HIV Infections, Infection, Human Immunodeficiency Virus
Conditions
Keywords
HIV -1, GSK1265744, maintenance phase, dose selection
Brief summary
The study is designed to select a dose of GSK1265744 primarily on the basis of antiviral activity and tolerability in HIV-1 infected, antiretroviral naive subjects. This study consists of two parts: Induction Phase: Approximately 200 subjects will be randomized (50 subjects in each of the 4 treatment arms). The Induction Phase consists of a 24 week dose-ranging evaluation of GSK1265744 at blinded doses of 10 mg, 30 mg and 60 mg once-daily and a control arm of open-label efavirenz (EFV) 600 mg once daily. The background dual nucleoside reverse transcriptase inhibitor (NRTI) antiretroviral therapy (ART) for all arms will be either abacavir/lamivudine (ABC/3TC) or tenofovir/emtricitabine (TDF/FTC) as selected by the Investigator. Subjects randomized to a GSK1265744 containing arm, who successfully complete 24 weeks on study and demonstrate virologic suppression (defined as having a plasma HIV-1 ribonucleic acid \[RNA\] \<50 copies per milliliter \[c/mL\] before Week 24, with no signs of virologic rebound) will become eligible for the Maintenance Phase of this study. Maintenance Phase: The background NRTIs will be discontinued and the subjects will continue their randomized dose of GSK1265744 in combination with rilpivirine (RPV) 25 mg once-daily for an additional 72 weeks. The Maintenance phase will evaluate the ability of this two drug ART regimen to maintain virologic suppression through Week 48, Week 72 and Week 96. Subjects randomized to the EFV arm will continue on their randomized regimen through Week 96. After completion of the maintenance phase, subjects could enroll in the Open-Label Phase to continue GSK1265744 + RPV treatment as long as they continue to derive clinical benefit and until it is locally approved and commercially available.
Interventions
DRUGGSK1265744 10 mg
GSK1265744 10 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase of the study and in combination with Rilpivirine 25 mg in the Maintenance Phase of the study.
DRUGGSK1265744 30 mg
GSK1265744 30 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase of the study and in combination with Rilpivirine 25 mg in the Maintenance Phase of the study.
DRUGGSK1265744 60 mg
GSK1265744 60 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase of the study and in combination with Rilpivirine 25 mg in the Maintenance Phase of the study.
DRUGEfavirenz 600 mg
Efavirenz 600 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase and Maintenance Phase of the study.
Rilpivirine 25 mg will be administered orally once daily in combination with GSK1265744 10 mg, 30 mg and 60 mg in the Maintenance Phase of the study.
DRUGPlacebo
Placebo matching to GSK1265744 will be administered along with GSK1265744 10 mg and 30 mg in the Induction phase and Maintenance phase of the study.
DRUGAbacavir/Lamivudine (ABC/3TC) or Tenofovir/Emtricitabine (TDF/FTC)
The background dual NRTI therapy for all arms in the Induction Phase and Efavirenz 600 mg arm in the Maintenance Phase will be either abacavir 600 mg + lamivudine 300 mg (ABC/3TC) or tenofovir 300 mg + emtricitabine 200 mg (TDF/FTC) as selected by the Investigator.
Sponsors
GlaxoSmithKline
ViiV Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HIV-1 infected male or female subjects \>= 18 years of age * Screening plasma HIV-1 RNA \>=1000 c/mL * CD4+ cell count \>=200 cells/millimeter (mm)\^3 * ART-naive defined as having =\<10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection * Female subjects of child bearing potential are eligible to enter if they are not pregnant and willing to use protocol-specified methods of contraception to prevent pregnancy during the study
Exclusion criteria
* Any evidence at screening of an active Centers for Disease and Prevention Control (CDC) Category C disease * Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening * History of ongoing or clinically relevant hepatitis within the previous 6 months, and subjects with moderate to severe hepatic impairment will be excluded * Women who are breastfeeding * Subject, who in the investigator's judgment, poses a significant suicide risk * Any clinically significant finding on screening or baseline electrocardiograph (ECG) * The presence of any specific laboratory abnormalities at Screening * History of cardiac disease * Clinically relevant pancreatitis * Subjects who are unlikely to complete the dosing schedule due to a pre-existing physical or mental condition * Any condition which impairs the absorption, distribution, metabolism or excretion of the investigational product * Any evidence of primary resistance based upon the presence of a major resistance associated mutation in the Screening HIV genotype, or any historical genotype * Treatment with any protocol-specified excluded medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (mL) at Week 48 Using the Missing, Switch, Discontinuation Equals Failure (MSDF) Algorithm | Week 48 | Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA \<50 copies/mL at Week 48 was determined using the MSDF algorithm based on the current US Food and Drug Administration (FDA) definition of Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. ITT-E Population comprised of all randomized participants who received at least one dose of investigational product. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96 | Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA \<400 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on randomized therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period. |
| Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312 | Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA \<50 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. |
| Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324 | Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA \<50 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period or open-label phase. |
| Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324 | Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed. |
| Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324 | Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. |
| Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease | Up to Week 324 | HIV-1 associated conditions were assessed according to the 1993 Centers for Disease Control and Prevention (CDC) Revised Classification System for HIV Infection in Adults. The clinical categories of HIV infection as per CDC system are class A=Asymptomatic HIV infection or lymphadenopathy or acute HIV infection; class B=symptomatic non-acquired immunodeficiency syndrome (AIDS) conditions and class C=AIDS indicator conditions. Number of participants experiencing disease progression is presented, where disease progression is defined as the progression from Baseline HIV disease status as follows: CDC class A at Baseline to CDC class C event; CDC Class B at Baseline to CDC Class C event; CDC Class C at Baseline to new CDC Class C event; and CDC class A, B or C at Baseline to death. |
| Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96 | CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed. |
| Change From Baseline in CD4+ Cell Count Over Time by Visit | Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324 | CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. |
| Number of Participants With Treatment Emergent Phenotypic Resistance | Up to Week 324 | Plasma samples were collected for drug resistance testing. Phenotypic resistance data for the following drugs under integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), NRTI and proteasome inhibitor drug classes is presented for participants with confirmed virologic failure: GSK1265744, Raltegravir \[RAL\], Delavirdine \[DLV\], Efavirenz \[EFV\], Etravirine \[ETR\], Nevirapine (NVP), RPV, 3TC, ABC, FTC, TDF, Zidovudine \[ZDV\], Stavudine \[d4T\], Didanosine \[ddI\], Atazanavir/ritonavir \[ATV/r\], Darunavir (DRV)/r, Fosamprenavir/r \[FPV/r\], Indinavir/r \[IDV/r\], Lopinavir/r \[LPV/r\], Nelfinavir \[NFV\], Ritonavir \[RTV\], Saquinavir/r \[SQV/r\], Tipranavir/r \[TPV/r\]. On-treatment Phenotypic Resistance population comprised of all participants in the ITT-E Population with available on-treatment phenotypic resistance data, excluding participants who are not protocol-defined virologic failures. |
| Number of Participants With Treatment Emergent Genotypic Mutations Associated With Development of Resistance | Up to Week 324 | Plasma samples were collected for drug resistance testing. The treatment emergent INI mutations associated with development of resistance to RAL, ELV, dolutegravir (DTG) or GSK1265744 and major resistance mutations to other classes (NRTI, NNRTI, PI) as defined by International AIDS society (IAS)-United States of America (USA) are presented. On-treatment Genotypic Resistance population comprised of all participants in the ITT-E Population with available on-treatment genotypic resistance data, excluding participants who are not protocol-defined virologic failures. |
| Number of Participants With Adherence to Study Treatment | Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312 | Number of participants with \>=90% adherence to study treatment based on pill count is summarized. |
| Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 16 and Week 24 Using MSDF Algorithm-Induction Phase | Week 16 and Week 24 | Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA \<50 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. |
| Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Weeks 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96 | Plasma samples were collected for quantitative analysis of HIV-1 RNA. The end point was determined using MSDF algorithm based on the current US FDA definition of Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. ITT-Maintenance Exposed (ME) Population comprised of all participants randomized to GSK1265744 and who received at least one dose of investigational product during maintenance phase of the study. |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Maintenance Phase | Week 24 to Week 96 | An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. Maintenance Safety Population comprised of all participants randomized to GSK1265744 and who were exposed to investigational products during the maintenance phase of the study with the exception of any participants with documented evidence of not having consumed any amount of investigational product. |
| Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Week 24 to Week 96 | Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotranferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), carbon dioxide(CO2)/bicarbonate, cholesterol, creatine kinase (CK), creatinine, glucose, low density lipoprotein (LDL) cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin and triglycerides. A toxicity is considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. |
| Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Week 24 to Week 96 | Blood samples were collected for the analysis of following hematology parameters: Activated Partial Thromboplastin Time (APTT), hemoglobin, international normalized ratio (INR), platelet count, prothrombin time (PT), total neutrophils and white blood cell (WBC) count. A toxicity is considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. |
| Number of Participants With AEs and SAEs Over Time | Up to Week 324 | An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. Safety Population comprised of all randomized participants who were exposed to investigational products with the exception of any participants with documented evidence of not having consumed any amount of investigational product. |
| Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Up to Week 324 | Blood samples were collected for the analysis of following clinical chemistry parameters: ALT, albumin, ALP, AST, CO2/bicarbonate, cholesterol, CK, creatinine, glucose, LDL cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin and triglycerides. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. |
| Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Up to Week 324 | Blood samples were collected for the analysis of following hematology parameters: APTT, hemoglobin, INR, platelet count, PT, total neutrophils and WBC count. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. |
| Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96 | Blood samples were collected for the analysis of ALT, AST and CK. Baseline value is the last pre-treatment value observed. |
| Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96 | Blood samples were collected for the analysis of creatinine and total bilirubin (T. bilirubin). Baseline value is the last pre-treatment value observed. |
| Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Baseline (Day 1), Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60 and 96 | Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. |
| Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96 | Blood samples were collected for the analysis of hemoglobin level. Baseline value is the last pre-treatment value observed. |
| Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96 | Blood samples were collected for the analysis of platelet count, total neutrophils (T. neutrophils) and WBC count. Baseline value is the last pre-treatment value observed. |
| Change From Baseline in ALT, AST and CK Over Time by Visit | Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324 | Blood samples were collected for the analysis of ALT, AST and CK. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. |
| Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324 | Blood samples were collected for the analysis of creatinine and total bilirubin. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. |
| Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Baseline (Day 1) and Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60, 96, 180, 204, 252 and 264 | Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. |
| Change From Baseline in Hemoglobin Level Over Time by Visit | Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324 | Blood samples were collected for the analysis of hemoglobin level. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. |
| Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324 | Blood samples were collected for the analysis of total neutrophils, platelet count and WBC count. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. |
| Percentage of Participants Who Discontinued Investigational Product Due to Adverse Events | Up to Week 324 | AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented. |
| Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings | Up to Week 324 | Twelve lead ECG was performed after the participants had rested in a semi-supine position for at least 5 minutes using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for worst case results at any time on-treatment is presented. |
| Number of Participants With AEs and SAEs-Induction Phase | Up to Week 24 | An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. |
| Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Up to Week 24 | Blood samples were collected for the analysis of following clinical chemistry parameters: ALT, albumin, ALP, AST, CO2/bicarbonate, chloride, cholesterol, CK, creatinine, glucose, high density lipoprotein (HDL) cholesterol, LDL cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin, triglycerides and urea/blood urea nitrogen (BUN). A toxicity was considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. |
| Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Up to Week 24 | Blood samples were collected for the analysis of following hematology parameters: APTT, basophils, eosinophils, hematocrit, hemoglobin, INR, lymphocytes, mean corpuscle volume (MCV), monocytes, platelet count, PT, red blood cell (RBC) count, total neutrophils and WBC count. A toxicity was considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. |
| Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Induction Phase | Up to Week 24 | AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented. |
| Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Maintenance Phase | Week 24 to Week 96 | AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented. |
| Area Under the Concentration Time Curve Over the Dosing Interval (AUC[0-tau]) for GSK1265744 at Week 2 | pre-dose, 1, 2, 3, 4, 8 and 24 hours post-dose at Week 2 | Blood samples for pharmacokinetic (PK) analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. The PK Summary Population comprised of all participants who received GSK1265744 or with Rilpivirine, underwent intensive and/or limited/sparse PK sampling during the study, and provided evaluable GSK1265744 and Rilpivirine plasma concentration data |
| Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96 | Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with HIV-1 RNA \<400 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. |
| Concentration at the End of a Dosing Interval (Ctau) for GSK1265744 at Week 2 | pre-dose, 1, 2, 3, 4, 8 and 24 hours post dose at Week 2 | Blood samples for PK analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. |
| AUC(0 to Tau) for Rilpivirine | pre-dose and 2 to 4 hours post-dose at Weeks 26 and 36 | Data was not collected for analysis of rilpivirine PK parameters. |
| Cmax for Rilpivirine | pre-dose and 2 to 4 hours post-dose at Weeks 26 and 36 | Data was not collected for analysis of rilpivirine PK parameters. |
| Ctau for Rilpivirine | pre-dose and 2 to 4 hours post-dose at Weeks 26 and 36 | Data was not collected for analysis of rilpivirine PK parameters. |
| Maximum Observed Concentration (Cmax) for GSK1265744 at Week 2 | pre-dose, 1, 2, 3, 4, 8 and 24 hours post-dose at Week 2 | Blood samples for PK analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. |
Countries
Canada, United States
Participant flow
Recruitment details
This was a multicenter, two part study in human immunodeficiency virus-1 (HIV-1) infected antiretroviral therapy (ART) naïve adult participants conducted across 48 sites in the United States (US) and Canada.
Pre-assignment details
A total of 324 participants were screened, of which 80 failed screening and 244 participants were randomized to one of the four treatment arms in a ratio of 1:1:1:1. Of the 244 randomized participants, only 243 received atleast one dose of study treatment and comprised the Intent-to-Treat-Exposed (ITT-E) Population.
Participants by arm
| Arm | Count |
|---|---|
| GSK1265744 10 mg Participants were administered one tablet of GSK1265744 10 milligrams (mg) and one tablet of placebo once daily along with investigator selected, fixed dose dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine ABC/3TC 600 mg/300 mg or tenofovir/emtricitabine TDF/FTC 300 mg/200 mg from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 10 mg and one tablet of placebo in combination with one tablet of rilpivirine (RPV) 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | 60 |
| GSK1265744 30 mg Participants were administered one tablet of GSK1265744 30 mg and one tablet of placebo once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received one tablet of GSK1265744 30 mg and one tablet of placebo in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | 60 |
| GSK1265744 60 mg Participants were administered two tablets of GSK1265744 30 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants received two tablets of GSK1265744 30 mg in combination with one tablet of RPV 25 mg once daily from Week 24 to Week 96. Participants continuing in the open-label phase of the study received one tablet of GSK1265744 30 mg along with RPV 25 mg once daily. All doses were administered orally with a meal. | 61 |
| Efavirenz 600 mg Participants were administered one tablet of efavirenz 600 mg once daily along with investigator selected, fixed dose dual NRTI therapy (either ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg) from Day 1 to Week 24 during the double-blind induction phase. In the Maintenance Phase (double-blind), eligible participants continued to receive one tablet of efavirenz 600 mg in combination with ABC/3TC or TDF/FTC once daily. Participants in this arm did not enter open-label phase and were considered to have completed the study after Week 96. | 62 |
| Total | 243 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Induction Phase (Day 1 to Week 24) | Adverse Event | 0 | 1 | 3 | 7 |
| Induction Phase (Day 1 to Week 24) | Lack of Efficacy | 4 | 1 | 2 | 3 |
| Induction Phase (Day 1 to Week 24) | Lost to Follow-up | 1 | 2 | 0 | 3 |
| Induction Phase (Day 1 to Week 24) | Physician Decision | 0 | 1 | 0 | 1 |
| Induction Phase (Day 1 to Week 24) | Protocol Violation | 2 | 1 | 1 | 0 |
| Induction Phase (Day 1 to Week 24) | Withdrawal by Subject | 1 | 1 | 0 | 1 |
| Maintenance Phase (Week 24 to Week 96) | Adverse Event | 1 | 0 | 1 | 2 |
| Maintenance Phase (Week 24 to Week 96) | Lack of Efficacy | 1 | 1 | 0 | 2 |
| Maintenance Phase (Week 24 to Week 96) | Lost to Follow-up | 2 | 0 | 1 | 2 |
| Maintenance Phase (Week 24 to Week 96) | Physician Decision | 0 | 1 | 0 | 0 |
| Maintenance Phase (Week 24 to Week 96) | Withdrawal by Subject | 2 | 3 | 1 | 0 |
| Open-label (Week 96 to Week 324) | Adverse Event | 3 | 2 | 1 | 0 |
| Open-label (Week 96 to Week 324) | Lack of Efficacy | 4 | 1 | 0 | 0 |
| Open-label (Week 96 to Week 324) | Lost to Follow-up | 5 | 4 | 5 | 0 |
| Open-label (Week 96 to Week 324) | Physician Decision | 0 | 1 | 1 | 0 |
| Open-label (Week 96 to Week 324) | Protocol Violation | 1 | 1 | 0 | 0 |
| Open-label (Week 96 to Week 324) | Site closed | 1 | 0 | 0 | 0 |
| Open-label (Week 96 to Week 324) | Withdrawal by Subject | 2 | 3 | 1 | 0 |
Baseline characteristics
| Characteristic | GSK1265744 10 mg | Total | Efavirenz 600 mg | GSK1265744 60 mg | GSK1265744 30 mg |
|---|---|---|---|---|---|
| Age, Continuous | 34.0 Years STANDARD_DEVIATION 9.91 | 35.1 Years STANDARD_DEVIATION 10.68 | 35.6 Years STANDARD_DEVIATION 12.3 | 36.2 Years STANDARD_DEVIATION 10.15 | 34.4 Years STANDARD_DEVIATION 10.24 |
| Race/Ethnicity, Customized Af Am/Af Her and Asian and White | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Af Am/Af Her & Nat Hawaiian/other Pacific islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Af Am/Af Her & White | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized African American (Af Am)/African Heritage (Her) | 21 Participants | 76 Participants | 20 Participants | 18 Participants | 17 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native (Nat) | 0 Participants | 4 Participants | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native & White | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian-Central/South Asian Her | 1 Participants | 3 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian-Japanese/East Asian/South East Asian Her | 0 Participants | 3 Participants | 0 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian & White | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 37 Participants | 151 Participants | 39 Participants | 36 Participants | 39 Participants |
| Sex: Female, Male Female | 3 Participants | 10 Participants | 1 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Male | 57 Participants | 233 Participants | 61 Participants | 57 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 | 0 / 61 | 0 / 62 | 0 / 52 | 0 / 53 | 0 / 55 | 0 / 47 | 0 / 46 | 1 / 47 | 1 / 51 | 0 / 0 |
| other Total, other adverse events | 46 / 60 | 47 / 60 | 50 / 61 | 54 / 62 | 35 / 52 | 44 / 53 | 47 / 55 | 33 / 47 | 32 / 46 | 38 / 47 | 40 / 51 | 0 / 0 |
| serious Total, serious adverse events | 2 / 60 | 0 / 60 | 2 / 61 | 2 / 62 | 5 / 52 | 5 / 53 | 5 / 55 | 2 / 47 | 7 / 46 | 8 / 47 | 5 / 51 | 0 / 0 |
Outcome results
Primary
Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (mL) at Week 48 Using the Missing, Switch, Discontinuation Equals Failure (MSDF) Algorithm
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA \<50 copies/mL at Week 48 was determined using the MSDF algorithm based on the current US Food and Drug Administration (FDA) definition of Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. ITT-E Population comprised of all randomized participants who received at least one dose of investigational product.
Time frame: Week 48
Population: ITT-E Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK1265744 10 mg | Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (mL) at Week 48 Using the Missing, Switch, Discontinuation Equals Failure (MSDF) Algorithm | 80 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (mL) at Week 48 Using the Missing, Switch, Discontinuation Equals Failure (MSDF) Algorithm | 80 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (mL) at Week 48 Using the Missing, Switch, Discontinuation Equals Failure (MSDF) Algorithm | 87 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (mL) at Week 48 Using the Missing, Switch, Discontinuation Equals Failure (MSDF) Algorithm | 71 Percentage of participants |
Secondary
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96
Blood samples were collected for the analysis of ALT, AST and CK. Baseline value is the last pre-treatment value observed.
Time frame: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 32; n=52, 53, 55, 45 | 21.9 International Units per Liter | Standard Deviation 7.74 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 28; n=51, 52, 52, 45 | 22.6 International Units per Liter | Standard Deviation 8.77 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 60; n=48, 47, 53, 44 | 21.4 International Units per Liter | Standard Deviation 17.7 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 32; n=52, 53, 55, 45 | 205.6 International Units per Liter | Standard Deviation 171.74 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 26; n=48, 50, 53, 45 | 28.4 International Units per Liter | Standard Deviation 28.28 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 24; n=56, 53, 56, 47 | 23.3 International Units per Liter | Standard Deviation 8.93 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 72; n=47, 47, 52, 42 | 19.9 International Units per Liter | Standard Deviation 9.98 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 12; n=58, 53, 57, 51 | 25.0 International Units per Liter | Standard Deviation 15.37 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 20; n=56, 54, 55, 49 | 26.0 International Units per Liter | Standard Deviation 20.71 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 16; n=57, 54, 57, 52 | 24.2 International Units per Liter | Standard Deviation 12.7 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 84; n=46, 48, 52, 42 | 20.1 International Units per Liter | Standard Deviation 11.56 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 96; n=45, 48, 52, 40 | 542.7 International Units per Liter | Standard Deviation 2451.57 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 12; n=58, 53, 57, 51 | 26.3 International Units per Liter | Standard Deviation 13.4 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 8; n=58, 55, 57, 54 | 28.7 International Units per Liter | Standard Deviation 31.34 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 96; n=45, 48, 52, 40 | 22.0 International Units per Liter | Standard Deviation 18.2 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 28; n=51, 52, 52, 45 | 213.4 International Units per Liter | Standard Deviation 182.12 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 4; n=58, 57, 59, 57 | 24.0 International Units per Liter | Standard Deviation 7.95 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 2; n=58, 56, 58, 58 | 25.6 International Units per Liter | Standard Deviation 8.36 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Baseline; n=60, 60, 61, 62 | 25.0 International Units per Liter | Standard Deviation 7.36 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 26; n=48, 50, 53, 45 | 344.1 International Units per Liter | Standard Deviation 606.1 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 16; n=57, 54, 57, 52 | 26.0 International Units per Liter | Standard Deviation 25.88 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 72; n=47, 47, 52, 42 | 182.5 International Units per Liter | Standard Deviation 148.31 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 24; n=56, 53, 56, 47 | 226.0 International Units per Liter | Standard Deviation 230.13 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 20; n=56, 54, 55, 49 | 342.7 International Units per Liter | Standard Deviation 953.66 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 20; n=56, 54, 55, 49 | 22.3 International Units per Liter | Standard Deviation 11.62 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 60; n=48, 47, 53, 44 | 315.7 International Units per Liter | Standard Deviation 730.27 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 16; n=57, 54, 57, 52 | 195.1 International Units per Liter | Standard Deviation 180.51 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Baseline; n=60, 60, 61, 62 | 23.9 International Units per Liter | Standard Deviation 12.38 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 24; n=56, 53, 56, 47 | 20.9 International Units per Liter | Standard Deviation 9.86 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 4; n=58, 57, 59, 57 | 23.1 International Units per Liter | Standard Deviation 14.31 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 12; n=58, 53, 57, 51 | 316.1 International Units per Liter | Standard Deviation 570.21 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 8; n=58, 55, 57, 54 | 413.3 International Units per Liter | Standard Deviation 1523.18 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 26; n=48, 50, 53, 45 | 24.2 International Units per Liter | Standard Deviation 16.54 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 84; n=46, 48, 52, 42 | 204.3 International Units per Liter | Standard Deviation 160.3 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 4; n=58, 57, 59, 57 | 196.7 International Units per Liter | Standard Deviation 159.74 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 2; n=58, 56, 58, 58 | 237.9 International Units per Liter | Standard Deviation 271.07 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 28; n=51, 52, 52, 45 | 20.4 International Units per Liter | Standard Deviation 11.47 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 48; n=51, 53, 54, 44 | 203.5 International Units per Liter | Standard Deviation 136.48 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Baseline; n=60, 60, 61, 62 | 197.3 International Units per Liter | Standard Deviation 178.83 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 96; n=45, 48, 52, 40 | 23.6 International Units per Liter | Standard Deviation 22.38 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 32; n=52, 53, 55, 45 | 19.5 International Units per Liter | Standard Deviation 9.83 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 40; n=52, 53, 55, 44 | 259.5 International Units per Liter | Standard Deviation 381.33 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 84; n=46, 48, 52, 42 | 22.3 International Units per Liter | Standard Deviation 8.1 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 72; n=47, 47, 52, 42 | 21.8 International Units per Liter | Standard Deviation 7.67 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 36; n=52, 52, 55, 45 | 23.4 International Units per Liter | Standard Deviation 26.79 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 8; n=58, 55, 57, 54 | 25.4 International Units per Liter | Standard Deviation 16.06 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 60; n=48, 47, 53, 44 | 23.4 International Units per Liter | Standard Deviation 10.41 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 48; n=51, 53, 54, 44 | 21.4 International Units per Liter | Standard Deviation 8.02 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 40; n=52, 53, 55, 44 | 22.7 International Units per Liter | Standard Deviation 18.13 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 2; n=58, 56, 58, 58 | 24.0 International Units per Liter | Standard Deviation 13.29 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 40; n=52, 53, 55, 44 | 24.7 International Units per Liter | Standard Deviation 14.04 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 36; n=52, 52, 55, 45 | 29.2 International Units per Liter | Standard Deviation 39.15 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 48; n=51, 53, 54, 44 | 18.4 International Units per Liter | Standard Deviation 8.32 |
| GSK1265744 10 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 36; n=52, 52, 55, 45 | 528.4 International Units per Liter | Standard Deviation 1984.77 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 12; n=58, 53, 57, 51 | 314.7 International Units per Liter | Standard Deviation 1116.09 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Baseline; n=60, 60, 61, 62 | 28.1 International Units per Liter | Standard Deviation 17.65 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 2; n=58, 56, 58, 58 | 26.3 International Units per Liter | Standard Deviation 17.81 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 4; n=58, 57, 59, 57 | 25.6 International Units per Liter | Standard Deviation 17.29 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 8; n=58, 55, 57, 54 | 29.3 International Units per Liter | Standard Deviation 23.15 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 12; n=58, 53, 57, 51 | 31.4 International Units per Liter | Standard Deviation 28.65 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 16; n=57, 54, 57, 52 | 28.5 International Units per Liter | Standard Deviation 27.79 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 20; n=56, 54, 55, 49 | 24.9 International Units per Liter | Standard Deviation 15.72 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 24; n=56, 53, 56, 47 | 27.5 International Units per Liter | Standard Deviation 23.9 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 26; n=48, 50, 53, 45 | 26.6 International Units per Liter | Standard Deviation 26.63 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 28; n=51, 52, 52, 45 | 26.5 International Units per Liter | Standard Deviation 26.66 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 32; n=52, 53, 55, 45 | 26.9 International Units per Liter | Standard Deviation 27.66 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 36; n=52, 52, 55, 45 | 24.7 International Units per Liter | Standard Deviation 17.44 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 40; n=52, 53, 55, 44 | 24.6 International Units per Liter | Standard Deviation 15.43 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 48; n=51, 53, 54, 44 | 24.8 International Units per Liter | Standard Deviation 15.91 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 60; n=48, 47, 53, 44 | 25.9 International Units per Liter | Standard Deviation 16.69 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 72; n=47, 47, 52, 42 | 30.7 International Units per Liter | Standard Deviation 28.68 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 84; n=46, 48, 52, 42 | 29.9 International Units per Liter | Standard Deviation 20.77 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 96; n=45, 48, 52, 40 | 48.7 International Units per Liter | Standard Deviation 153.96 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Baseline; n=60, 60, 61, 62 | 27.5 International Units per Liter | Standard Deviation 11.15 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 2; n=58, 56, 58, 58 | 26.6 International Units per Liter | Standard Deviation 11.38 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 4; n=58, 57, 59, 57 | 25.0 International Units per Liter | Standard Deviation 11.37 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 8; n=58, 55, 57, 54 | 29.5 International Units per Liter | Standard Deviation 23.47 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 12; n=58, 53, 57, 51 | 29.0 International Units per Liter | Standard Deviation 24.56 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 16; n=57, 54, 57, 52 | 29.2 International Units per Liter | Standard Deviation 24 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 20; n=56, 54, 55, 49 | 24.2 International Units per Liter | Standard Deviation 10.38 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 24; n=56, 53, 56, 47 | 27.2 International Units per Liter | Standard Deviation 17.43 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 26; n=48, 50, 53, 45 | 26.9 International Units per Liter | Standard Deviation 18.86 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 28; n=51, 52, 52, 45 | 26.7 International Units per Liter | Standard Deviation 16.58 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 32; n=52, 53, 55, 45 | 26.5 International Units per Liter | Standard Deviation 19.14 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 36; n=52, 52, 55, 45 | 25.4 International Units per Liter | Standard Deviation 12.5 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 40; n=52, 53, 55, 44 | 24.5 International Units per Liter | Standard Deviation 10.35 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 48; n=51, 53, 54, 44 | 24.3 International Units per Liter | Standard Deviation 12.32 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 60; n=48, 47, 53, 44 | 25.3 International Units per Liter | Standard Deviation 12.77 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 72; n=47, 47, 52, 42 | 31.0 International Units per Liter | Standard Deviation 22.8 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 84; n=46, 48, 52, 42 | 29.2 International Units per Liter | Standard Deviation 16.93 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 96; n=45, 48, 52, 40 | 47.7 International Units per Liter | Standard Deviation 150.51 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Baseline; n=60, 60, 61, 62 | 295.9 International Units per Liter | Standard Deviation 604.02 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 2; n=58, 56, 58, 58 | 276.1 International Units per Liter | Standard Deviation 468.74 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 4; n=58, 57, 59, 57 | 221.8 International Units per Liter | Standard Deviation 426.95 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 8; n=58, 55, 57, 54 | 427.2 International Units per Liter | Standard Deviation 1518.27 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 16; n=57, 54, 57, 52 | 427.3 International Units per Liter | Standard Deviation 1339.99 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 20; n=56, 54, 55, 49 | 202.1 International Units per Liter | Standard Deviation 309.41 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 24; n=56, 53, 56, 47 | 306.3 International Units per Liter | Standard Deviation 690.18 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 26; n=48, 50, 53, 45 | 267.7 International Units per Liter | Standard Deviation 516.53 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 28; n=51, 52, 52, 45 | 276.8 International Units per Liter | Standard Deviation 581.44 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 32; n=52, 53, 55, 45 | 248.8 International Units per Liter | Standard Deviation 525.79 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 36; n=52, 52, 55, 45 | 242.9 International Units per Liter | Standard Deviation 353.65 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 40; n=52, 53, 55, 44 | 225.4 International Units per Liter | Standard Deviation 342.5 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 48; n=51, 53, 54, 44 | 219.3 International Units per Liter | Standard Deviation 527.75 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 60; n=48, 47, 53, 44 | 215.5 International Units per Liter | Standard Deviation 340.37 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 72; n=47, 47, 52, 42 | 354.0 International Units per Liter | Standard Deviation 911.76 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 84; n=46, 48, 52, 42 | 329.2 International Units per Liter | Standard Deviation 724.97 |
| GSK1265744 30 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 96; n=45, 48, 52, 40 | 272.8 International Units per Liter | Standard Deviation 589.15 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 12; n=58, 53, 57, 51 | 211.8 International Units per Liter | Standard Deviation 174.07 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 84; n=46, 48, 52, 42 | 195.0 International Units per Liter | Standard Deviation 164.14 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 20; n=56, 54, 55, 49 | 30.3 International Units per Liter | Standard Deviation 24.34 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 32; n=52, 53, 55, 45 | 23.2 International Units per Liter | Standard Deviation 14.67 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 16; n=57, 54, 57, 52 | 213.3 International Units per Liter | Standard Deviation 190.94 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 40; n=52, 53, 55, 44 | 26.5 International Units per Liter | Standard Deviation 14.21 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 84; n=46, 48, 52, 42 | 25.2 International Units per Liter | Standard Deviation 9.11 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 2; n=58, 56, 58, 58 | 27.2 International Units per Liter | Standard Deviation 14.49 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 20; n=56, 54, 55, 49 | 485.3 International Units per Liter | Standard Deviation 1835.11 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 36; n=52, 52, 55, 45 | 255.2 International Units per Liter | Standard Deviation 275.74 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 16; n=57, 54, 57, 52 | 26.9 International Units per Liter | Standard Deviation 18.68 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 48; n=51, 53, 54, 44 | 24.8 International Units per Liter | Standard Deviation 19.6 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 24; n=56, 53, 56, 47 | 243.0 International Units per Liter | Standard Deviation 228.95 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 48; n=51, 53, 54, 44 | 219.8 International Units per Liter | Standard Deviation 195.62 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 96; n=45, 48, 52, 40 | 25.9 International Units per Liter | Standard Deviation 12.9 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 72; n=47, 47, 52, 42 | 247.7 International Units per Liter | Standard Deviation 348.72 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 26; n=48, 50, 53, 45 | 242.5 International Units per Liter | Standard Deviation 275.72 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 40; n=52, 53, 55, 44 | 292.6 International Units per Liter | Standard Deviation 360.32 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 12; n=58, 53, 57, 51 | 26.6 International Units per Liter | Standard Deviation 16.27 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 28; n=51, 52, 52, 45 | 24.8 International Units per Liter | Standard Deviation 14.94 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Baseline; n=60, 60, 61, 62 | 28.1 International Units per Liter | Standard Deviation 12.01 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 48; n=51, 53, 54, 44 | 24.2 International Units per Liter | Standard Deviation 9.26 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Baseline; n=60, 60, 61, 62 | 181.2 International Units per Liter | Standard Deviation 217.99 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 28; n=51, 52, 52, 45 | 290.4 International Units per Liter | Standard Deviation 457.59 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 2; n=58, 56, 58, 58 | 26.8 International Units per Liter | Standard Deviation 8.6 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 28; n=51, 52, 52, 45 | 25.5 International Units per Liter | Standard Deviation 11.24 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 96; n=45, 48, 52, 40 | 25.5 International Units per Liter | Standard Deviation 21.23 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 36; n=52, 52, 55, 45 | 24.2 International Units per Liter | Standard Deviation 15.6 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 4; n=58, 57, 59, 57 | 28.3 International Units per Liter | Standard Deviation 16.29 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 36; n=52, 52, 55, 45 | 26.4 International Units per Liter | Standard Deviation 11.38 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 2; n=58, 56, 58, 58 | 184.8 International Units per Liter | Standard Deviation 143.83 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 60; n=48, 47, 53, 44 | 30.4 International Units per Liter | Standard Deviation 21 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 8; n=58, 55, 57, 54 | 32.8 International Units per Liter | Standard Deviation 37.43 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 26; n=48, 50, 53, 45 | 23.5 International Units per Liter | Standard Deviation 10.77 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 84; n=46, 48, 52, 42 | 25.3 International Units per Liter | Standard Deviation 19.53 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Baseline; n=60, 60, 61, 62 | 28.5 International Units per Liter | Standard Deviation 20.6 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 12; n=58, 53, 57, 51 | 25.5 International Units per Liter | Standard Deviation 8.05 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 4; n=58, 57, 59, 57 | 180.5 International Units per Liter | Standard Deviation 174.8 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 32; n=52, 53, 55, 45 | 25.6 International Units per Liter | Standard Deviation 9.19 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 32; n=52, 53, 55, 45 | 311.3 International Units per Liter | Standard Deviation 437.31 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 16; n=57, 54, 57, 52 | 26.5 International Units per Liter | Standard Deviation 9.42 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 40; n=52, 53, 55, 44 | 25.8 International Units per Liter | Standard Deviation 23.5 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 72; n=47, 47, 52, 42 | 26.3 International Units per Liter | Standard Deviation 20.29 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 60; n=48, 47, 53, 44 | 399.6 International Units per Liter | Standard Deviation 923.74 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 20; n=56, 54, 55, 49 | 31.7 International Units per Liter | Standard Deviation 26.31 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 8; n=58, 55, 57, 54 | 451.7 International Units per Liter | Standard Deviation 1788.6 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 4; n=58, 57, 59, 57 | 30.3 International Units per Liter | Standard Deviation 24.25 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 8; n=58, 55, 57, 54 | 35.9 International Units per Liter | Standard Deviation 63.11 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 24; n=56, 53, 56, 47 | 28.6 International Units per Liter | Standard Deviation 14.12 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 24; n=56, 53, 56, 47 | 28.6 International Units per Liter | Standard Deviation 19.62 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 60; n=48, 47, 53, 44 | 28.1 International Units per Liter | Standard Deviation 26.7 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 96; n=45, 48, 52, 40 | 199.7 International Units per Liter | Standard Deviation 194.46 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 26; n=48, 50, 53, 45 | 24.5 International Units per Liter | Standard Deviation 6.64 |
| GSK1265744 60 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 72; n=47, 47, 52, 42 | 26.4 International Units per Liter | Standard Deviation 10.52 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 26; n=48, 50, 53, 45 | 25.8 International Units per Liter | Standard Deviation 12.21 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 28; n=51, 52, 52, 45 | 23.7 International Units per Liter | Standard Deviation 7.89 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 36; n=52, 52, 55, 45 | 303.1 International Units per Liter | Standard Deviation 615.91 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 32; n=52, 53, 55, 45 | 25.4 International Units per Liter | Standard Deviation 12.33 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 40; n=52, 53, 55, 44 | 23.4 International Units per Liter | Standard Deviation 10.92 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 4; n=58, 57, 59, 57 | 31.4 International Units per Liter | Standard Deviation 27.43 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 36; n=52, 52, 55, 45 | 26.3 International Units per Liter | Standard Deviation 13.66 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 40; n=52, 53, 55, 44 | 23.0 International Units per Liter | Standard Deviation 6.17 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 36; n=52, 52, 55, 45 | 23.5 International Units per Liter | Standard Deviation 10.53 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 48; n=51, 53, 54, 44 | 23.7 International Units per Liter | Standard Deviation 8.45 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 40; n=52, 53, 55, 44 | 150.2 International Units per Liter | Standard Deviation 96.11 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 60; n=48, 47, 53, 44 | 24.9 International Units per Liter | Standard Deviation 8.31 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 32; n=52, 53, 55, 45 | 23.1 International Units per Liter | Standard Deviation 10.19 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 72; n=47, 47, 52, 42 | 22.9 International Units per Liter | Standard Deviation 6.28 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 84; n=46, 48, 52, 42 | 258.6 International Units per Liter | Standard Deviation 650.38 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 84; n=46, 48, 52, 42 | 29.9 International Units per Liter | Standard Deviation 37.33 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 28; n=51, 52, 52, 45 | 24.2 International Units per Liter | Standard Deviation 13.67 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 96; n=45, 48, 52, 40 | 27.7 International Units per Liter | Standard Deviation 35.71 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 48; n=51, 53, 54, 44 | 146.3 International Units per Liter | Standard Deviation 88.07 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Baseline; n=60, 60, 61, 62 | 349.8 International Units per Liter | Standard Deviation 1521.09 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 26; n=48, 50, 53, 45 | 28.3 International Units per Liter | Standard Deviation 25.23 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 2; n=58, 56, 58, 58 | 30.0 International Units per Liter | Standard Deviation 26.73 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 2; n=58, 56, 58, 58 | 512.1 International Units per Liter | Standard Deviation 2788.37 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 4; n=58, 57, 59, 57 | 236.2 International Units per Liter | Standard Deviation 563.36 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 24; n=56, 53, 56, 47 | 25.7 International Units per Liter | Standard Deviation 13.31 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 8; n=58, 55, 57, 54 | 152.9 International Units per Liter | Standard Deviation 94.19 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 20; n=56, 54, 55, 49 | 27.0 International Units per Liter | Standard Deviation 15.71 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 12; n=58, 53, 57, 51 | 161.2 International Units per Liter | Standard Deviation 163.26 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 60; n=48, 47, 53, 44 | 168.0 International Units per Liter | Standard Deviation 154.36 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 16; n=57, 54, 57, 52 | 646.5 International Units per Liter | Standard Deviation 3471.23 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 16; n=57, 54, 57, 52 | 30.4 International Units per Liter | Standard Deviation 22.55 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 20; n=56, 54, 55, 49 | 528.2 International Units per Liter | Standard Deviation 2643.29 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 96; n=45, 48, 52, 40 | 281.1 International Units per Liter | Standard Deviation 903.71 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 24; n=56, 53, 56, 47 | 247.4 International Units per Liter | Standard Deviation 498.72 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 12; n=58, 53, 57, 51 | 25.7 International Units per Liter | Standard Deviation 17.44 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 26; n=48, 50, 53, 45 | 163.5 International Units per Liter | Standard Deviation 156.79 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 72; n=47, 47, 52, 42 | 120.5 International Units per Liter | Standard Deviation 59.89 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Baseline; n=60, 60, 61, 62 | 31.5 International Units per Liter | Standard Deviation 28.43 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 96; n=45, 48, 52, 40 | 24.3 International Units per Liter | Standard Deviation 22.84 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 2; n=58, 56, 58, 58 | 32.8 International Units per Liter | Standard Deviation 51.17 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 28; n=51, 52, 52, 45 | 154.7 International Units per Liter | Standard Deviation 168.77 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 4; n=58, 57, 59, 57 | 29.0 International Units per Liter | Standard Deviation 15.61 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 84; n=46, 48, 52, 42 | 27.1 International Units per Liter | Standard Deviation 32.55 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 8; n=58, 55, 57, 54 | 25.0 International Units per Liter | Standard Deviation 13.21 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 8; n=58, 55, 57, 54 | 24.4 International Units per Liter | Standard Deviation 5.73 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Baseline; n=60, 60, 61, 62 | 30.5 International Units per Liter | Standard Deviation 29.21 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 12; n=58, 53, 57, 51 | 24.4 International Units per Liter | Standard Deviation 9.49 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 72; n=47, 47, 52, 42 | 22.7 International Units per Liter | Standard Deviation 9.62 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 16; n=57, 54, 57, 52 | 36.7 International Units per Liter | Standard Deviation 71.83 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | CK; Week 32; n=52, 53, 55, 45 | 254.7 International Units per Liter | Standard Deviation 778.33 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 20; n=56, 54, 55, 49 | 28.7 International Units per Liter | Standard Deviation 28.75 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 60; n=48, 47, 53, 44 | 24.9 International Units per Liter | Standard Deviation 13.59 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | AST; Week 24; n=56, 53, 56, 47 | 26.1 International Units per Liter | Standard Deviation 9.61 |
| Efavirenz 600 mg | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 | ALT; Week 48; n=51, 53, 54, 44 | 22.6 International Units per Liter | Standard Deviation 10.92 |
Secondary
Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96
CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed.
Time frame: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1265744 10 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 96; n=46, 46, 52, 41 | 726.2 Cells per cubic millimeter | Standard Deviation 272.28 |
| GSK1265744 10 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 84; n=46, 48, 52, 42 | 718.3 Cells per cubic millimeter | Standard Deviation 212.59 |
| GSK1265744 10 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 12; n=58, 53, 57, 51 | 588.4 Cells per cubic millimeter | Standard Deviation 208.15 |
| GSK1265744 10 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 36; n=52, 53, 55, 45 | 638.7 Cells per cubic millimeter | Standard Deviation 198.05 |
| GSK1265744 10 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 48; n=51, 53, 54, 44 | 677.3 Cells per cubic millimeter | Standard Deviation 219.75 |
| GSK1265744 10 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 16; n=57, 54, 57, 52 | 608.3 Cells per cubic millimeter | Standard Deviation 200.34 |
| GSK1265744 10 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 32; n=52, 53, 55, 45 | 638.1 Cells per cubic millimeter | Standard Deviation 192.54 |
| GSK1265744 10 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 40; n=52, 53, 55, 45 | 650.2 Cells per cubic millimeter | Standard Deviation 218.4 |
| GSK1265744 10 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 20; n=56, 54, 56, 49 | 607.3 Cells per cubic millimeter | Standard Deviation 204.87 |
| GSK1265744 10 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Baseline; n=60, 60, 61, 62 | 445.5 Cells per cubic millimeter | Standard Deviation 155.6 |
| GSK1265744 10 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 2; n=57, 56, 59, 59 | 544.0 Cells per cubic millimeter | Standard Deviation 197.54 |
| GSK1265744 10 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 28; n=49, 52, 52, 45 | 652.2 Cells per cubic millimeter | Standard Deviation 225.32 |
| GSK1265744 10 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 24; n=56, 53, 56, 47 | 614.6 Cells per cubic millimeter | Standard Deviation 194.13 |
| GSK1265744 10 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 8; n=58, 56, 57, 55 | 576.6 Cells per cubic millimeter | Standard Deviation 196.55 |
| GSK1265744 10 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 4; n=58, 57, 59, 57 | 580.5 Cells per cubic millimeter | Standard Deviation 230.4 |
| GSK1265744 10 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 60; n=48, 47, 53, 44 | 668.1 Cells per cubic millimeter | Standard Deviation 222.61 |
| GSK1265744 10 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 26; n=48, 50, 53, 45 | 632.8 Cells per cubic millimeter | Standard Deviation 210.93 |
| GSK1265744 10 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 72; n=47, 48, 52, 42 | 683.2 Cells per cubic millimeter | Standard Deviation 242.75 |
| GSK1265744 30 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 26; n=48, 50, 53, 45 | 629.5 Cells per cubic millimeter | Standard Deviation 207.34 |
| GSK1265744 30 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 48; n=51, 53, 54, 44 | 687.2 Cells per cubic millimeter | Standard Deviation 227.06 |
| GSK1265744 30 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 28; n=49, 52, 52, 45 | 635.9 Cells per cubic millimeter | Standard Deviation 217.52 |
| GSK1265744 30 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 32; n=52, 53, 55, 45 | 650.8 Cells per cubic millimeter | Standard Deviation 209.66 |
| GSK1265744 30 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 40; n=52, 53, 55, 45 | 658.5 Cells per cubic millimeter | Standard Deviation 204.08 |
| GSK1265744 30 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 36; n=52, 53, 55, 45 | 658.6 Cells per cubic millimeter | Standard Deviation 226.51 |
| GSK1265744 30 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 4; n=58, 57, 59, 57 | 522.0 Cells per cubic millimeter | Standard Deviation 205.8 |
| GSK1265744 30 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 84; n=46, 48, 52, 42 | 736.9 Cells per cubic millimeter | Standard Deviation 271.85 |
| GSK1265744 30 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 8; n=58, 56, 57, 55 | 555.2 Cells per cubic millimeter | Standard Deviation 210.92 |
| GSK1265744 30 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Baseline; n=60, 60, 61, 62 | 444.9 Cells per cubic millimeter | Standard Deviation 190.98 |
| GSK1265744 30 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 12; n=58, 53, 57, 51 | 599.0 Cells per cubic millimeter | Standard Deviation 226.06 |
| GSK1265744 30 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 16; n=57, 54, 57, 52 | 595.8 Cells per cubic millimeter | Standard Deviation 197.47 |
| GSK1265744 30 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 96; n=46, 46, 52, 41 | 722.9 Cells per cubic millimeter | Standard Deviation 246.22 |
| GSK1265744 30 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 72; n=47, 48, 52, 42 | 651.3 Cells per cubic millimeter | Standard Deviation 217.19 |
| GSK1265744 30 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 20; n=56, 54, 56, 49 | 607.4 Cells per cubic millimeter | Standard Deviation 199.27 |
| GSK1265744 30 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 60; n=48, 47, 53, 44 | 720.9 Cells per cubic millimeter | Standard Deviation 268.74 |
| GSK1265744 30 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 24; n=56, 53, 56, 47 | 626.5 Cells per cubic millimeter | Standard Deviation 210.63 |
| GSK1265744 30 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 2; n=57, 56, 59, 59 | 525.1 Cells per cubic millimeter | Standard Deviation 181.29 |
| GSK1265744 60 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 72; n=47, 48, 52, 42 | 710.9 Cells per cubic millimeter | Standard Deviation 259.89 |
| GSK1265744 60 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 40; n=52, 53, 55, 45 | 667.6 Cells per cubic millimeter | Standard Deviation 187.3 |
| GSK1265744 60 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Baseline; n=60, 60, 61, 62 | 459.0 Cells per cubic millimeter | Standard Deviation 170.64 |
| GSK1265744 60 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 2; n=57, 56, 59, 59 | 549.3 Cells per cubic millimeter | Standard Deviation 206.68 |
| GSK1265744 60 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 4; n=58, 57, 59, 57 | 545.8 Cells per cubic millimeter | Standard Deviation 196.79 |
| GSK1265744 60 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 8; n=58, 56, 57, 55 | 544.3 Cells per cubic millimeter | Standard Deviation 176.01 |
| GSK1265744 60 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 12; n=58, 53, 57, 51 | 596.6 Cells per cubic millimeter | Standard Deviation 181 |
| GSK1265744 60 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 16; n=57, 54, 57, 52 | 599.7 Cells per cubic millimeter | Standard Deviation 166.77 |
| GSK1265744 60 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 20; n=56, 54, 56, 49 | 636.6 Cells per cubic millimeter | Standard Deviation 225.04 |
| GSK1265744 60 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 24; n=56, 53, 56, 47 | 658.0 Cells per cubic millimeter | Standard Deviation 253.19 |
| GSK1265744 60 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 26; n=48, 50, 53, 45 | 645.8 Cells per cubic millimeter | Standard Deviation 188.61 |
| GSK1265744 60 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 28; n=49, 52, 52, 45 | 653.3 Cells per cubic millimeter | Standard Deviation 261.11 |
| GSK1265744 60 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 32; n=52, 53, 55, 45 | 665.2 Cells per cubic millimeter | Standard Deviation 246.84 |
| GSK1265744 60 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 36; n=52, 53, 55, 45 | 720.3 Cells per cubic millimeter | Standard Deviation 257.85 |
| GSK1265744 60 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 48; n=51, 53, 54, 44 | 713.8 Cells per cubic millimeter | Standard Deviation 215.7 |
| GSK1265744 60 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 60; n=48, 47, 53, 44 | 719.8 Cells per cubic millimeter | Standard Deviation 219.04 |
| GSK1265744 60 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 84; n=46, 48, 52, 42 | 735.0 Cells per cubic millimeter | Standard Deviation 236.25 |
| GSK1265744 60 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 96; n=46, 46, 52, 41 | 743.1 Cells per cubic millimeter | Standard Deviation 242.23 |
| Efavirenz 600 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 26; n=48, 50, 53, 45 | 625.7 Cells per cubic millimeter | Standard Deviation 196.46 |
| Efavirenz 600 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 2; n=57, 56, 59, 59 | 487.0 Cells per cubic millimeter | Standard Deviation 222.84 |
| Efavirenz 600 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 48; n=51, 53, 54, 44 | 732.6 Cells per cubic millimeter | Standard Deviation 273.19 |
| Efavirenz 600 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 24; n=56, 53, 56, 47 | 599.5 Cells per cubic millimeter | Standard Deviation 219.52 |
| Efavirenz 600 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 20; n=56, 54, 56, 49 | 607.7 Cells per cubic millimeter | Standard Deviation 186.36 |
| Efavirenz 600 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Baseline; n=60, 60, 61, 62 | 456.5 Cells per cubic millimeter | Standard Deviation 196.11 |
| Efavirenz 600 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 60; n=48, 47, 53, 44 | 733.9 Cells per cubic millimeter | Standard Deviation 238.9 |
| Efavirenz 600 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 16; n=57, 54, 57, 52 | 594.4 Cells per cubic millimeter | Standard Deviation 212.63 |
| Efavirenz 600 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 12; n=58, 53, 57, 51 | 564.3 Cells per cubic millimeter | Standard Deviation 222.99 |
| Efavirenz 600 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 72; n=47, 48, 52, 42 | 722.5 Cells per cubic millimeter | Standard Deviation 263.47 |
| Efavirenz 600 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 8; n=58, 56, 57, 55 | 531.4 Cells per cubic millimeter | Standard Deviation 175.95 |
| Efavirenz 600 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 4; n=58, 57, 59, 57 | 509.9 Cells per cubic millimeter | Standard Deviation 198.21 |
| Efavirenz 600 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 96; n=46, 46, 52, 41 | 747.8 Cells per cubic millimeter | Standard Deviation 263.27 |
| Efavirenz 600 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 84; n=46, 48, 52, 42 | 744.7 Cells per cubic millimeter | Standard Deviation 250.9 |
| Efavirenz 600 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 36; n=52, 53, 55, 45 | 651.5 Cells per cubic millimeter | Standard Deviation 212.15 |
| Efavirenz 600 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 32; n=52, 53, 55, 45 | 663.8 Cells per cubic millimeter | Standard Deviation 257.25 |
| Efavirenz 600 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 40; n=52, 53, 55, 45 | 687.9 Cells per cubic millimeter | Standard Deviation 241.35 |
| Efavirenz 600 mg | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 | Week 28; n=49, 52, 52, 45 | 635.7 Cells per cubic millimeter | Standard Deviation 224.72 |
Secondary
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96
Blood samples were collected for the analysis of creatinine and total bilirubin (T. bilirubin). Baseline value is the last pre-treatment value observed.
Time frame: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 12; n=58, 53, 57, 51 | 83.8 Micromoles per liter | Standard Deviation 13.33 |
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Baseline; n=60, 60, 61, 62 | 80.4 Micromoles per liter | Standard Deviation 13.69 |
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 72; n=47, 47, 52, 42 | 10.8 Micromoles per liter | Standard Deviation 6.63 |
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 28; n=51, 52, 52, 45 | 83.0 Micromoles per liter | Standard Deviation 13.32 |
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 20; n=56, 54, 55, 49 | 9.0 Micromoles per liter | Standard Deviation 4.09 |
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 16; n=57, 54, 57, 52 | 9.6 Micromoles per liter | Standard Deviation 5.04 |
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 40; n=52, 53, 55, 44 | 10.8 Micromoles per liter | Standard Deviation 5.81 |
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 32; n=52, 53, 55, 45 | 83.8 Micromoles per liter | Standard Deviation 14.11 |
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 4; n=58, 57, 59, 57 | 9.4 Micromoles per liter | Standard Deviation 4.4 |
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 4; n=58, 57, 59, 57 | 82.9 Micromoles per liter | Standard Deviation 15.45 |
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 16; n=57, 54, 57, 52 | 83.4 Micromoles per liter | Standard Deviation 17.07 |
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 36; n=52, 52, 55, 45 | 83.5 Micromoles per liter | Standard Deviation 12.68 |
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 26; n=48, 50, 53, 45 | 10.6 Micromoles per liter | Standard Deviation 4.97 |
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 84; n=46, 48, 52, 42 | 11.7 Micromoles per liter | Standard Deviation 6.77 |
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 36; n=52, 52, 55, 45 | 10.3 Micromoles per liter | Standard Deviation 5.25 |
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 40; n=52, 53, 55, 44 | 83.3 Micromoles per liter | Standard Deviation 12.6 |
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 2; n=58, 56, 58, 58 | 9.2 Micromoles per liter | Standard Deviation 4.48 |
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 2; n=58, 56, 58, 58 | 83.8 Micromoles per liter | Standard Deviation 14.33 |
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 60; n=48, 47, 53, 44 | 11.2 Micromoles per liter | Standard Deviation 4.28 |
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 48; n=51, 53, 54, 44 | 83.4 Micromoles per liter | Standard Deviation 13.48 |
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 20; n=56, 54, 55, 49 | 83.2 Micromoles per liter | Standard Deviation 12.95 |
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 24; n=56, 53, 56, 47 | 9.6 Micromoles per liter | Standard Deviation 5.18 |
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 32; n=52, 53, 55, 45 | 9.8 Micromoles per liter | Standard Deviation 4.91 |
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 60; n=48, 47, 53, 44 | 83.9 Micromoles per liter | Standard Deviation 13.85 |
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 8; n=58, 55, 57, 54 | 9.3 Micromoles per liter | Standard Deviation 4.5 |
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 96; n=45, 48, 52, 40 | 10.3 Micromoles per liter | Standard Deviation 5.29 |
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 24; n=56, 53, 56, 47 | 83.2 Micromoles per liter | Standard Deviation 13.07 |
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 72; n=47, 47, 52, 42 | 84.5 Micromoles per liter | Standard Deviation 12.46 |
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Baseline; n=60, 60, 61, 62 | 9.2 Micromoles per liter | Standard Deviation 4.65 |
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 12; n=58, 53, 57, 51 | 9.5 Micromoles per liter | Standard Deviation 5.16 |
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 84; n=46, 48, 52, 42 | 85.0 Micromoles per liter | Standard Deviation 15.06 |
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 48; n=51, 53, 54, 44 | 10.0 Micromoles per liter | Standard Deviation 4.96 |
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 26; n=48, 50, 53, 45 | 83.4 Micromoles per liter | Standard Deviation 13.45 |
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 28; n=51, 52, 52, 45 | 10.3 Micromoles per liter | Standard Deviation 4.87 |
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 96; n=45, 48, 52, 40 | 82.0 Micromoles per liter | Standard Deviation 11.46 |
| GSK1265744 10 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 8; n=58, 55, 57, 54 | 82.9 Micromoles per liter | Standard Deviation 13.79 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 96; n=45, 48, 52, 40 | 86.4 Micromoles per liter | Standard Deviation 17.24 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 26; n=48, 50, 53, 45 | 9.9 Micromoles per liter | Standard Deviation 5.83 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Baseline; n=60, 60, 61, 62 | 9.4 Micromoles per liter | Standard Deviation 4.59 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 2; n=58, 56, 58, 58 | 9.1 Micromoles per liter | Standard Deviation 4.5 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 24; n=56, 53, 56, 47 | 9.8 Micromoles per liter | Standard Deviation 5.09 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 4; n=58, 57, 59, 57 | 9.3 Micromoles per liter | Standard Deviation 4.47 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 12; n=58, 53, 57, 51 | 82.7 Micromoles per liter | Standard Deviation 14.96 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 20; n=56, 54, 55, 49 | 9.0 Micromoles per liter | Standard Deviation 4.91 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 12; n=58, 53, 57, 51 | 8.9 Micromoles per liter | Standard Deviation 3.79 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 60; n=48, 47, 53, 44 | 9.8 Micromoles per liter | Standard Deviation 3.75 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 16; n=57, 54, 57, 52 | 8.5 Micromoles per liter | Standard Deviation 3.9 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 16; n=57, 54, 57, 52 | 82.3 Micromoles per liter | Standard Deviation 14.56 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 84; n=46, 48, 52, 42 | 9.9 Micromoles per liter | Standard Deviation 4.35 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 20; n=56, 54, 55, 49 | 82.0 Micromoles per liter | Standard Deviation 14.42 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 8; n=58, 55, 57, 54 | 9.0 Micromoles per liter | Standard Deviation 3.33 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 48; n=51, 53, 54, 44 | 9.6 Micromoles per liter | Standard Deviation 3.86 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 24; n=56, 53, 56, 47 | 83.3 Micromoles per liter | Standard Deviation 15.56 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 96; n=45, 48, 52, 40 | 9.9 Micromoles per liter | Standard Deviation 4.58 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 26; n=48, 50, 53, 45 | 82.6 Micromoles per liter | Standard Deviation 14.15 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 40; n=52, 53, 55, 44 | 11.2 Micromoles per liter | Standard Deviation 7.04 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 28; n=51, 52, 52, 45 | 83.8 Micromoles per liter | Standard Deviation 14.84 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Baseline; n=60, 60, 61, 62 | 80.5 Micromoles per liter | Standard Deviation 13.55 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 32; n=52, 53, 55, 45 | 82.6 Micromoles per liter | Standard Deviation 13.48 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 36; n=52, 52, 55, 45 | 10.1 Micromoles per liter | Standard Deviation 5.47 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 36; n=52, 52, 55, 45 | 84.6 Micromoles per liter | Standard Deviation 13.22 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 40; n=52, 53, 55, 44 | 83.2 Micromoles per liter | Standard Deviation 13.04 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 32; n=52, 53, 55, 45 | 9.8 Micromoles per liter | Standard Deviation 4.8 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 48; n=51, 53, 54, 44 | 83.1 Micromoles per liter | Standard Deviation 14.55 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 2; n=58, 56, 58, 58 | 83.3 Micromoles per liter | Standard Deviation 14.1 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 60; n=48, 47, 53, 44 | 83.0 Micromoles per liter | Standard Deviation 14.31 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 4; n=58, 57, 59, 57 | 83.0 Micromoles per liter | Standard Deviation 14.55 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 28; n=51, 52, 52, 45 | 10.2 Micromoles per liter | Standard Deviation 5.9 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 72; n=47, 47, 52, 42 | 86.1 Micromoles per liter | Standard Deviation 14.95 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 8; n=58, 55, 57, 54 | 82.2 Micromoles per liter | Standard Deviation 13.03 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 84; n=46, 48, 52, 42 | 84.8 Micromoles per liter | Standard Deviation 17.41 |
| GSK1265744 30 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 72; n=47, 47, 52, 42 | 10.0 Micromoles per liter | Standard Deviation 4.89 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 26; n=48, 50, 53, 45 | 12.0 Micromoles per liter | Standard Deviation 5.11 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 8; n=58, 55, 57, 54 | 83.5 Micromoles per liter | Standard Deviation 14.41 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Baseline; n=60, 60, 61, 62 | 79.9 Micromoles per liter | Standard Deviation 14.11 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 4; n=58, 57, 59, 57 | 84.2 Micromoles per liter | Standard Deviation 14.28 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 12; n=58, 53, 57, 51 | 84.1 Micromoles per liter | Standard Deviation 14.64 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 16; n=57, 54, 57, 52 | 82.4 Micromoles per liter | Standard Deviation 14.16 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 20; n=56, 54, 55, 49 | 86.1 Micromoles per liter | Standard Deviation 14.34 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 24; n=56, 53, 56, 47 | 85.2 Micromoles per liter | Standard Deviation 13.93 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 26; n=48, 50, 53, 45 | 87.0 Micromoles per liter | Standard Deviation 13.82 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 28; n=51, 52, 52, 45 | 85.6 Micromoles per liter | Standard Deviation 13.96 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 32; n=52, 53, 55, 45 | 85.7 Micromoles per liter | Standard Deviation 14.34 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 36; n=52, 52, 55, 45 | 86.7 Micromoles per liter | Standard Deviation 16.21 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 40; n=52, 53, 55, 44 | 85.4 Micromoles per liter | Standard Deviation 14.38 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 48; n=51, 53, 54, 44 | 85.0 Micromoles per liter | Standard Deviation 14.54 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 60; n=48, 47, 53, 44 | 85.2 Micromoles per liter | Standard Deviation 14.57 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 72; n=47, 47, 52, 42 | 87.3 Micromoles per liter | Standard Deviation 14.95 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 84; n=46, 48, 52, 42 | 87.3 Micromoles per liter | Standard Deviation 13.15 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 96; n=45, 48, 52, 40 | 88.5 Micromoles per liter | Standard Deviation 14.75 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Baseline; n=60, 60, 61, 62 | 10.5 Micromoles per liter | Standard Deviation 5.48 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 2; n=58, 56, 58, 58 | 10.0 Micromoles per liter | Standard Deviation 5.92 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 4; n=58, 57, 59, 57 | 9.8 Micromoles per liter | Standard Deviation 6.05 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 8; n=58, 55, 57, 54 | 10.1 Micromoles per liter | Standard Deviation 5.55 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 12; n=58, 53, 57, 51 | 10.2 Micromoles per liter | Standard Deviation 5.47 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 16; n=57, 54, 57, 52 | 10.4 Micromoles per liter | Standard Deviation 4.88 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 20; n=56, 54, 55, 49 | 10.4 Micromoles per liter | Standard Deviation 5.49 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 24; n=56, 53, 56, 47 | 10.0 Micromoles per liter | Standard Deviation 4.52 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 2; n=58, 56, 58, 58 | 84.6 Micromoles per liter | Standard Deviation 15.27 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 28; n=51, 52, 52, 45 | 11.4 Micromoles per liter | Standard Deviation 4.77 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 32; n=52, 53, 55, 45 | 11.7 Micromoles per liter | Standard Deviation 6.7 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 36; n=52, 52, 55, 45 | 12.2 Micromoles per liter | Standard Deviation 6.08 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 40; n=52, 53, 55, 44 | 12.3 Micromoles per liter | Standard Deviation 6.67 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 48; n=51, 53, 54, 44 | 10.4 Micromoles per liter | Standard Deviation 4.91 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 60; n=48, 47, 53, 44 | 11.6 Micromoles per liter | Standard Deviation 6.28 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 72; n=47, 47, 52, 42 | 11.4 Micromoles per liter | Standard Deviation 5.87 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 84; n=46, 48, 52, 42 | 12.0 Micromoles per liter | Standard Deviation 5.64 |
| GSK1265744 60 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 96; n=45, 48, 52, 40 | 12.5 Micromoles per liter | Standard Deviation 5.61 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 26; n=48, 50, 53, 45 | 6.8 Micromoles per liter | Standard Deviation 2.19 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 84; n=46, 48, 52, 42 | 79.7 Micromoles per liter | Standard Deviation 11.2 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 60; n=48, 47, 53, 44 | 77.9 Micromoles per liter | Standard Deviation 11.13 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 2; n=58, 56, 58, 58 | 83.8 Micromoles per liter | Standard Deviation 15.29 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 28; n=51, 52, 52, 45 | 6.4 Micromoles per liter | Standard Deviation 1.51 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 48; n=51, 53, 54, 44 | 79.0 Micromoles per liter | Standard Deviation 12.52 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 40; n=52, 53, 55, 44 | 79.2 Micromoles per liter | Standard Deviation 15.99 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 72; n=47, 47, 52, 42 | 6.5 Micromoles per liter | Standard Deviation 1.4 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 32; n=52, 53, 55, 45 | 6.6 Micromoles per liter | Standard Deviation 1.74 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 36; n=52, 52, 55, 45 | 78.4 Micromoles per liter | Standard Deviation 10.87 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 32; n=52, 53, 55, 45 | 78.1 Micromoles per liter | Standard Deviation 9.9 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Baseline; n=60, 60, 61, 62 | 83.1 Micromoles per liter | Standard Deviation 13.41 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 36; n=52, 52, 55, 45 | 6.5 Micromoles per liter | Standard Deviation 1.71 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 28; n=51, 52, 52, 45 | 78.5 Micromoles per liter | Standard Deviation 10.34 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 26; n=48, 50, 53, 45 | 78.6 Micromoles per liter | Standard Deviation 9.61 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 72; n=47, 47, 52, 42 | 77.7 Micromoles per liter | Standard Deviation 11.44 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 40; n=52, 53, 55, 44 | 6.3 Micromoles per liter | Standard Deviation 1.53 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 24; n=56, 53, 56, 47 | 80.0 Micromoles per liter | Standard Deviation 20.74 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 20; n=56, 54, 55, 49 | 79.5 Micromoles per liter | Standard Deviation 11.72 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 96; n=45, 48, 52, 40 | 6.8 Micromoles per liter | Standard Deviation 1.8 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 48; n=51, 53, 54, 44 | 6.6 Micromoles per liter | Standard Deviation 1.65 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 16; n=57, 54, 57, 52 | 79.6 Micromoles per liter | Standard Deviation 11.83 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 12; n=58, 53, 57, 51 | 81.1 Micromoles per liter | Standard Deviation 12.83 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 84; n=46, 48, 52, 42 | 6.6 Micromoles per liter | Standard Deviation 2.27 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 16; n=57, 54, 57, 52 | 7.0 Micromoles per liter | Standard Deviation 2.61 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 12; n=58, 53, 57, 51 | 7.0 Micromoles per liter | Standard Deviation 2.57 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 8; n=58, 55, 57, 54 | 6.3 Micromoles per liter | Standard Deviation 1.46 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 60; n=48, 47, 53, 44 | 7.0 Micromoles per liter | Standard Deviation 2.13 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 20; n=56, 54, 55, 49 | 6.8 Micromoles per liter | Standard Deviation 1.67 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 4; n=58, 57, 59, 57 | 6.4 Micromoles per liter | Standard Deviation 1.61 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 2; n=58, 56, 58, 58 | 6.8 Micromoles per liter | Standard Deviation 1.71 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 8; n=58, 55, 57, 54 | 82.4 Micromoles per liter | Standard Deviation 13.94 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Week 24; n=56, 53, 56, 47 | 6.6 Micromoles per liter | Standard Deviation 1.6 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | T. Bilirubin; Baseline; n=60, 60, 61, 62 | 9.7 Micromoles per liter | Standard Deviation 4.42 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 96; n=45, 48, 52, 40 | 81.0 Micromoles per liter | Standard Deviation 10.1 |
| Efavirenz 600 mg | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 | Creatinine; Week 4; n=58, 57, 59, 57 | 83.1 Micromoles per liter | Standard Deviation 14.22 |
Secondary
Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96
Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed.
Time frame: Baseline (Day 1), Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60 and 96
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1265744 10 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Week 24; n=52, 53, 55, 46 | 127.9 Milliliters per minute | Standard Deviation 30.9 |
| GSK1265744 10 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Week 16; n=55, 53, 56, 49 | 132.4 Milliliters per minute | Standard Deviation 50.97 |
| GSK1265744 10 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Week 2; n=1, 1, 0, 3 | 96.0 Milliliters per minute | — |
| GSK1265744 10 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Week 8; n=2, 1, 1, 1 | 125.0 Milliliters per minute | Standard Deviation 35.36 |
| GSK1265744 10 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Week 4; n=58, 57, 59, 57 | 129.3 Milliliters per minute | Standard Deviation 31.29 |
| GSK1265744 10 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Baseline; n=60, 60, 61, 62 | 131.0 Milliliters per minute | Standard Deviation 28.18 |
| GSK1265744 10 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Week 96; n=45, 48, 52, 40 | 130.8 Milliliters per minute | Standard Deviation 40.8 |
| GSK1265744 10 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Week 48; n=51, 50, 54, 44 | 127.0 Milliliters per minute | Standard Deviation 30.01 |
| GSK1265744 10 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Week 20; n=2, 0, 0, 1 | 137.0 Milliliters per minute | Standard Deviation 11.31 |
| GSK1265744 30 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Week 2; n=1, 1, 0, 3 | 106.0 Milliliters per minute | — |
| GSK1265744 30 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Week 40; n=0, 1, 0, 0 | 180.0 Milliliters per minute | — |
| GSK1265744 30 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Week 48; n=51, 50, 54, 44 | 139.2 Milliliters per minute | Standard Deviation 42.07 |
| GSK1265744 30 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Week 96; n=45, 48, 52, 40 | 137.7 Milliliters per minute | Standard Deviation 45.07 |
| GSK1265744 30 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Week 4; n=58, 57, 59, 57 | 132.5 Milliliters per minute | Standard Deviation 42.28 |
| GSK1265744 30 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Week 8; n=2, 1, 1, 1 | 124.0 Milliliters per minute | — |
| GSK1265744 30 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Week 16; n=55, 53, 56, 49 | 139.4 Milliliters per minute | Standard Deviation 42.3 |
| GSK1265744 30 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Baseline; n=60, 60, 61, 62 | 135.2 Milliliters per minute | Standard Deviation 41.33 |
| GSK1265744 30 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Week 24; n=52, 53, 55, 46 | 132.8 Milliliters per minute | Standard Deviation 39.93 |
| GSK1265744 30 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Week 26; n=0, 1, 0, 0 | 147.0 Milliliters per minute | — |
| GSK1265744 60 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Week 24; n=52, 53, 55, 46 | 120.7 Milliliters per minute | Standard Deviation 27.41 |
| GSK1265744 60 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Week 96; n=45, 48, 52, 40 | 116.6 Milliliters per minute | Standard Deviation 27.05 |
| GSK1265744 60 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Baseline; n=60, 60, 61, 62 | 128.3 Milliliters per minute | Standard Deviation 33.51 |
| GSK1265744 60 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Week 8; n=2, 1, 1, 1 | 143.0 Milliliters per minute | — |
| GSK1265744 60 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Week 4; n=58, 57, 59, 57 | 122.4 Milliliters per minute | Standard Deviation 33 |
| GSK1265744 60 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Week 48; n=51, 50, 54, 44 | 122.3 Milliliters per minute | Standard Deviation 29.21 |
| GSK1265744 60 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Week 16; n=55, 53, 56, 49 | 123.9 Milliliters per minute | Standard Deviation 31.85 |
| Efavirenz 600 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Week 96; n=45, 48, 52, 40 | 134.8 Milliliters per minute | Standard Deviation 43.35 |
| Efavirenz 600 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Week 60; n=0, 0, 0, 1 | 144.0 Milliliters per minute | — |
| Efavirenz 600 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Week 2; n=1, 1, 0, 3 | 99.0 Milliliters per minute | Standard Deviation 31 |
| Efavirenz 600 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Week 4; n=58, 57, 59, 57 | 127.0 Milliliters per minute | Standard Deviation 35.64 |
| Efavirenz 600 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Week 8; n=2, 1, 1, 1 | 101.0 Milliliters per minute | — |
| Efavirenz 600 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Week 16; n=55, 53, 56, 49 | 132.3 Milliliters per minute | Standard Deviation 39.97 |
| Efavirenz 600 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Week 20; n=2, 0, 0, 1 | 122.0 Milliliters per minute | — |
| Efavirenz 600 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Week 24; n=52, 53, 55, 46 | 135.1 Milliliters per minute | Standard Deviation 38.98 |
| Efavirenz 600 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Week 48; n=51, 50, 54, 44 | 131.0 Milliliters per minute | Standard Deviation 44.41 |
| Efavirenz 600 mg | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 | Baseline; n=60, 60, 61, 62 | 125.6 Milliliters per minute | Standard Deviation 35.3 |
Secondary
Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96
Blood samples were collected for the analysis of hemoglobin level. Baseline value is the last pre-treatment value observed.
Time frame: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1265744 10 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 28; n=50, 52, 52, 45 | 143.7 Grams per liter | Standard Deviation 13.2 |
| GSK1265744 10 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 26; n=48, 50, 53, 45 | 144.4 Grams per liter | Standard Deviation 13.3 |
| GSK1265744 10 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 16; n=57, 54, 57, 52 | 143.5 Grams per liter | Standard Deviation 11.77 |
| GSK1265744 10 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 96; n=46, 46, 52, 41 | 144.9 Grams per liter | Standard Deviation 12.41 |
| GSK1265744 10 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 24; n=56, 53, 56, 47 | 144.8 Grams per liter | Standard Deviation 12.66 |
| GSK1265744 10 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 20; n=56, 54, 55, 49 | 144.3 Grams per liter | Standard Deviation 13.33 |
| GSK1265744 10 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 72; n=47, 48, 52, 42 | 143.9 Grams per liter | Standard Deviation 10.24 |
| GSK1265744 10 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 60; n=48, 47, 52, 44 | 144.5 Grams per liter | Standard Deviation 9.91 |
| GSK1265744 10 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 4; n=57, 57, 59, 57 | 141.9 Grams per liter | Standard Deviation 13.39 |
| GSK1265744 10 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Baseline; n=60, 60, 61, 62 | 141.9 Grams per liter | Standard Deviation 12.46 |
| GSK1265744 10 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 48; n=51, 53, 54, 44 | 142.9 Grams per liter | Standard Deviation 9.15 |
| GSK1265744 10 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 40; n=51, 53, 55, 45 | 142.2 Grams per liter | Standard Deviation 11.06 |
| GSK1265744 10 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 8; n=58, 56, 56, 55 | 144.9 Grams per liter | Standard Deviation 13.1 |
| GSK1265744 10 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 84; n=46, 48, 51, 42 | 145.6 Grams per liter | Standard Deviation 11 |
| GSK1265744 10 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 36; n=52, 53, 55, 44 | 142.3 Grams per liter | Standard Deviation 11.07 |
| GSK1265744 10 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 32; n=51, 53, 55, 45 | 144.6 Grams per liter | Standard Deviation 9.53 |
| GSK1265744 10 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 12; n=58, 53, 57, 51 | 144.3 Grams per liter | Standard Deviation 12.19 |
| GSK1265744 10 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 2; n=57, 56, 59, 59 | 142.0 Grams per liter | Standard Deviation 13.84 |
| GSK1265744 30 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 4; n=57, 57, 59, 57 | 143.5 Grams per liter | Standard Deviation 11.69 |
| GSK1265744 30 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Baseline; n=60, 60, 61, 62 | 143.2 Grams per liter | Standard Deviation 10.66 |
| GSK1265744 30 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 2; n=57, 56, 59, 59 | 142.8 Grams per liter | Standard Deviation 11.68 |
| GSK1265744 30 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 8; n=58, 56, 56, 55 | 147.7 Grams per liter | Standard Deviation 11.88 |
| GSK1265744 30 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 12; n=58, 53, 57, 51 | 147.4 Grams per liter | Standard Deviation 10.6 |
| GSK1265744 30 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 16; n=57, 54, 57, 52 | 146.5 Grams per liter | Standard Deviation 10.71 |
| GSK1265744 30 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 20; n=56, 54, 55, 49 | 146.9 Grams per liter | Standard Deviation 11.23 |
| GSK1265744 30 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 24; n=56, 53, 56, 47 | 147.8 Grams per liter | Standard Deviation 10.69 |
| GSK1265744 30 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 26; n=48, 50, 53, 45 | 145.8 Grams per liter | Standard Deviation 11.63 |
| GSK1265744 30 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 28; n=50, 52, 52, 45 | 146.8 Grams per liter | Standard Deviation 10.89 |
| GSK1265744 30 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 32; n=51, 53, 55, 45 | 146.1 Grams per liter | Standard Deviation 10.44 |
| GSK1265744 30 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 36; n=52, 53, 55, 44 | 145.9 Grams per liter | Standard Deviation 11.24 |
| GSK1265744 30 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 40; n=51, 53, 55, 45 | 145.2 Grams per liter | Standard Deviation 11.03 |
| GSK1265744 30 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 48; n=51, 53, 54, 44 | 145.7 Grams per liter | Standard Deviation 10.59 |
| GSK1265744 30 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 60; n=48, 47, 52, 44 | 148.3 Grams per liter | Standard Deviation 10.96 |
| GSK1265744 30 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 72; n=47, 48, 52, 42 | 148.1 Grams per liter | Standard Deviation 10.15 |
| GSK1265744 30 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 84; n=46, 48, 51, 42 | 147.7 Grams per liter | Standard Deviation 10.04 |
| GSK1265744 30 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 96; n=46, 46, 52, 41 | 147.1 Grams per liter | Standard Deviation 11.06 |
| GSK1265744 60 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 12; n=58, 53, 57, 51 | 149.1 Grams per liter | Standard Deviation 11.25 |
| GSK1265744 60 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 28; n=50, 52, 52, 45 | 149.3 Grams per liter | Standard Deviation 10.15 |
| GSK1265744 60 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 32; n=51, 53, 55, 45 | 150.5 Grams per liter | Standard Deviation 11.19 |
| GSK1265744 60 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 8; n=58, 56, 56, 55 | 148.6 Grams per liter | Standard Deviation 12.1 |
| GSK1265744 60 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 96; n=46, 46, 52, 41 | 150.8 Grams per liter | Standard Deviation 10.37 |
| GSK1265744 60 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 36; n=52, 53, 55, 44 | 149.8 Grams per liter | Standard Deviation 11.26 |
| GSK1265744 60 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 84; n=46, 48, 51, 42 | 150.3 Grams per liter | Standard Deviation 10.38 |
| GSK1265744 60 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 40; n=51, 53, 55, 45 | 149.2 Grams per liter | Standard Deviation 11.71 |
| GSK1265744 60 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 4; n=57, 57, 59, 57 | 147.3 Grams per liter | Standard Deviation 12.13 |
| GSK1265744 60 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 48; n=51, 53, 54, 44 | 146.5 Grams per liter | Standard Deviation 12.48 |
| GSK1265744 60 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Baseline; n=60, 60, 61, 62 | 146.6 Grams per liter | Standard Deviation 13.41 |
| GSK1265744 60 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 60; n=48, 47, 52, 44 | 149.8 Grams per liter | Standard Deviation 10.82 |
| GSK1265744 60 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 2; n=57, 56, 59, 59 | 145.9 Grams per liter | Standard Deviation 12.05 |
| GSK1265744 60 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 20; n=56, 54, 55, 49 | 149.8 Grams per liter | Standard Deviation 11.11 |
| GSK1265744 60 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 16; n=57, 54, 57, 52 | 148.7 Grams per liter | Standard Deviation 11.08 |
| GSK1265744 60 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 24; n=56, 53, 56, 47 | 150.4 Grams per liter | Standard Deviation 11.65 |
| GSK1265744 60 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 72; n=47, 48, 52, 42 | 149.6 Grams per liter | Standard Deviation 11.46 |
| GSK1265744 60 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 26; n=48, 50, 53, 45 | 149.8 Grams per liter | Standard Deviation 11.47 |
| Efavirenz 600 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 20; n=56, 54, 55, 49 | 147.2 Grams per liter | Standard Deviation 12.18 |
| Efavirenz 600 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 72; n=47, 48, 52, 42 | 147.7 Grams per liter | Standard Deviation 11.22 |
| Efavirenz 600 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 48; n=51, 53, 54, 44 | 145.4 Grams per liter | Standard Deviation 12.24 |
| Efavirenz 600 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 28; n=50, 52, 52, 45 | 145.9 Grams per liter | Standard Deviation 13.17 |
| Efavirenz 600 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 8; n=58, 56, 56, 55 | 148.1 Grams per liter | Standard Deviation 12.32 |
| Efavirenz 600 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Baseline; n=60, 60, 61, 62 | 145.4 Grams per liter | Standard Deviation 12.39 |
| Efavirenz 600 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 2; n=57, 56, 59, 59 | 146.4 Grams per liter | Standard Deviation 13.49 |
| Efavirenz 600 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 32; n=51, 53, 55, 45 | 145.9 Grams per liter | Standard Deviation 11.41 |
| Efavirenz 600 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 12; n=58, 53, 57, 51 | 149.2 Grams per liter | Standard Deviation 13.14 |
| Efavirenz 600 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 96; n=46, 46, 52, 41 | 147.0 Grams per liter | Standard Deviation 11.03 |
| Efavirenz 600 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 60; n=48, 47, 52, 44 | 147.6 Grams per liter | Standard Deviation 12.73 |
| Efavirenz 600 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 36; n=52, 53, 55, 44 | 145.0 Grams per liter | Standard Deviation 10.73 |
| Efavirenz 600 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 4; n=57, 57, 59, 57 | 146.6 Grams per liter | Standard Deviation 13.06 |
| Efavirenz 600 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 16; n=57, 54, 57, 52 | 147.6 Grams per liter | Standard Deviation 12.05 |
| Efavirenz 600 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 26; n=48, 50, 53, 45 | 148.2 Grams per liter | Standard Deviation 12.32 |
| Efavirenz 600 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 40; n=51, 53, 55, 45 | 145.1 Grams per liter | Standard Deviation 9.98 |
| Efavirenz 600 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 24; n=56, 53, 56, 47 | 148.5 Grams per liter | Standard Deviation 11.31 |
| Efavirenz 600 mg | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 | Week 84; n=46, 48, 51, 42 | 147.0 Grams per liter | Standard Deviation 11.77 |
Secondary
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit
Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed.
Time frame: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Population: ITT-E Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 24; n=56, 53, 56, 48 | 1.615 Log10 copies per milliliter | Standard Deviation 0.101 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 96; n=45, 48, 52, 40 | 1.681 Log10 copies per milliliter | Standard Deviation 0.2783 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 240; n=31, 39, 45, 0 | 1.596 Log10 copies per milliliter | Standard Deviation 0.0268 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 84; n=46, 48, 52, 42 | 1.645 Log10 copies per milliliter | Standard Deviation 0.1838 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 72; n=47, 48, 52, 42 | 1.625 Log10 copies per milliliter | Standard Deviation 0.1584 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 26; n=48, 50, 53, 44 | 1.595 Log10 copies per milliliter | Standard Deviation 0.027 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 300; n=31, 37, 44, 0 | 1.601 Log10 copies per milliliter | Standard Deviation 0.0551 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 60; n=48, 48, 53, 44 | 1.648 Log10 copies per milliliter | Standard Deviation 0.2643 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 48; n=51, 53, 54, 44 | 1.686 Log10 copies per milliliter | Standard Deviation 0.4077 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 28; n=51, 52, 52, 45 | 1.591 Log10 copies per milliliter | Standard Deviation 0 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 228; n=32, 39, 47, 0 | 1.591 Log10 copies per milliliter | Standard Deviation 0 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 40; n=52, 53, 55, 45 | 1.612 Log10 copies per milliliter | Standard Deviation 0.1206 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 36; n=52, 53, 55, 45 | 1.604 Log10 copies per milliliter | Standard Deviation 0.0782 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 32; n=52, 53, 55, 45 | 1.609 Log10 copies per milliliter | Standard Deviation 0.0955 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 216; n=33, 39, 47, 0 | 1.591 Log10 copies per milliliter | Standard Deviation 0 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 252; n=31, 38, 47, 0 | 1.591 Log10 copies per milliliter | Standard Deviation 0 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 2; n=57, 56, 59, 59 | 1.883 Log10 copies per milliliter | Standard Deviation 0.4551 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 204; n=34, 39, 47, 0 | 1.628 Log10 copies per milliliter | Standard Deviation 0.2162 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 192; n=36, 40, 47, 0 | 1.689 Log10 copies per milliliter | Standard Deviation 0.4119 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 312; n=31, 33, 43, 0 | 1.597 Log10 copies per milliliter | Standard Deviation 0.0214 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 324; n=3, 4, 3, 0 | 1.591 Log10 copies per milliliter | Standard Deviation 0 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 288; n=30, 38, 45, 0 | 1.591 Log10 copies per milliliter | Standard Deviation 0 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 180; n=36, 41, 47, 0 | 1.613 Log10 copies per milliliter | Standard Deviation 0.1324 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 168; n=35, 43, 47, 0 | 1.665 Log10 copies per milliliter | Standard Deviation 0.3351 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 4; n=58, 57, 59, 57 | 1.706 Log10 copies per milliliter | Standard Deviation 0.3245 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 156; n=37, 42, 49, 0 | 1.634 Log10 copies per milliliter | Standard Deviation 0.185 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 8; n=59, 56, 57, 55 | 1.695 Log10 copies per milliliter | Standard Deviation 0.4114 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 276; n=31, 38, 45, 0 | 1.591 Log10 copies per milliliter | Standard Deviation 0 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 144; n=37, 45, 47, 0 | 1.682 Log10 copies per milliliter | Standard Deviation 0.4027 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 12; n=58, 52, 57, 51 | 1.643 Log10 copies per milliliter | Standard Deviation 0.2506 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 264; n=32, 38, 47, 0 | 1.591 Log10 copies per milliliter | Standard Deviation 0 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 132; n=40, 46, 49, 0 | 1.646 Log10 copies per milliliter | Standard Deviation 0.2491 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 16; n=57, 54, 57, 52 | 1.619 Log10 copies per milliliter | Standard Deviation 0.1418 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Baseline; n=60, 60, 61, 62 | 4.424 Log10 copies per milliliter | Standard Deviation 0.5834 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 120; n=41, 46, 49, 0 | 1.638 Log10 copies per milliliter | Standard Deviation 0.2216 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 108; n=43, 46, 49, 0 | 1.634 Log10 copies per milliliter | Standard Deviation 0.1979 |
| GSK1265744 10 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 20; n=56, 54, 56, 47 | 1.623 Log10 copies per milliliter | Standard Deviation 0.1175 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 240; n=31, 39, 45, 0 | 1.601 Log10 copies per milliliter | Standard Deviation 0.0465 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Baseline; n=60, 60, 61, 62 | 4.270 Log10 copies per milliliter | Standard Deviation 0.6359 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 4; n=58, 57, 59, 57 | 1.731 Log10 copies per milliliter | Standard Deviation 0.4141 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 96; n=45, 48, 52, 40 | 1.603 Log10 copies per milliliter | Standard Deviation 0.0861 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 252; n=31, 38, 47, 0 | 1.599 Log10 copies per milliliter | Standard Deviation 0.0461 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 312; n=31, 33, 43, 0 | 1.600 Log10 copies per milliliter | Standard Deviation 0.0494 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 2; n=57, 56, 59, 59 | 1.984 Log10 copies per milliliter | Standard Deviation 0.5786 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 8; n=59, 56, 57, 55 | 1.666 Log10 copies per milliliter | Standard Deviation 0.3676 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 12; n=58, 52, 57, 51 | 1.618 Log10 copies per milliliter | Standard Deviation 0.0786 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 16; n=57, 54, 57, 52 | 1.602 Log10 copies per milliliter | Standard Deviation 0.0354 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 20; n=56, 54, 56, 47 | 1.596 Log10 copies per milliliter | Standard Deviation 0.0346 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 24; n=56, 53, 56, 48 | 1.597 Log10 copies per milliliter | Standard Deviation 0.036 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 26; n=48, 50, 53, 44 | 1.602 Log10 copies per milliliter | Standard Deviation 0.0434 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 28; n=51, 52, 52, 45 | 1.607 Log10 copies per milliliter | Standard Deviation 0.0565 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 32; n=52, 53, 55, 45 | 1.620 Log10 copies per milliliter | Standard Deviation 0.1277 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 36; n=52, 53, 55, 45 | 1.610 Log10 copies per milliliter | Standard Deviation 0.107 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 40; n=52, 53, 55, 45 | 1.618 Log10 copies per milliliter | Standard Deviation 0.1214 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 48; n=51, 53, 54, 44 | 1.654 Log10 copies per milliliter | Standard Deviation 0.3673 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 60; n=48, 48, 53, 44 | 1.598 Log10 copies per milliliter | Standard Deviation 0.03 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 72; n=47, 48, 52, 42 | 1.697 Log10 copies per milliliter | Standard Deviation 0.4705 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 84; n=46, 48, 52, 42 | 1.643 Log10 copies per milliliter | Standard Deviation 0.2896 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 108; n=43, 46, 49, 0 | 1.609 Log10 copies per milliliter | Standard Deviation 0.0885 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 120; n=41, 46, 49, 0 | 1.591 Log10 copies per milliliter | Standard Deviation 0 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 132; n=40, 46, 49, 0 | 1.631 Log10 copies per milliliter | Standard Deviation 0.2097 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 144; n=37, 45, 47, 0 | 1.698 Log10 copies per milliliter | Standard Deviation 0.594 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 156; n=37, 42, 49, 0 | 1.603 Log10 copies per milliliter | Standard Deviation 0.052 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 168; n=35, 43, 47, 0 | 1.642 Log10 copies per milliliter | Standard Deviation 0.2908 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 180; n=36, 41, 47, 0 | 1.591 Log10 copies per milliliter | Standard Deviation 0 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 192; n=36, 40, 47, 0 | 1.591 Log10 copies per milliliter | Standard Deviation 0 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 204; n=34, 39, 47, 0 | 1.595 Log10 copies per milliliter | Standard Deviation 0.0252 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 216; n=33, 39, 47, 0 | 1.592 Log10 copies per milliliter | Standard Deviation 0.0052 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 228; n=32, 39, 47, 0 | 1.591 Log10 copies per milliliter | Standard Deviation 0 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 264; n=32, 38, 47, 0 | 1.591 Log10 copies per milliliter | Standard Deviation 0 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 276; n=31, 38, 45, 0 | 1.591 Log10 copies per milliliter | Standard Deviation 0 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 288; n=30, 38, 45, 0 | 1.592 Log10 copies per milliliter | Standard Deviation 0.0052 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 300; n=31, 37, 44, 0 | 1.591 Log10 copies per milliliter | Standard Deviation 0 |
| GSK1265744 30 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 324; n=3, 4, 3, 0 | 1.591 Log10 copies per milliliter | Standard Deviation 0 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 24; n=56, 53, 56, 48 | 1.603 Log10 copies per milliliter | Standard Deviation 0.0532 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 84; n=46, 48, 52, 42 | 1.592 Log10 copies per milliliter | Standard Deviation 0.0059 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 300; n=31, 37, 44, 0 | 1.625 Log10 copies per milliliter | Standard Deviation 0.1753 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 4; n=58, 57, 59, 57 | 1.725 Log10 copies per milliliter | Standard Deviation 0.275 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 192; n=36, 40, 47, 0 | 1.699 Log10 copies per milliliter | Standard Deviation 0.6971 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 252; n=31, 38, 47, 0 | 1.593 Log10 copies per milliliter | Standard Deviation 0.0157 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Baseline; n=60, 60, 61, 62 | 4.428 Log10 copies per milliliter | Standard Deviation 0.6418 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 204; n=34, 39, 47, 0 | 1.634 Log10 copies per milliliter | Standard Deviation 0.2936 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 156; n=37, 42, 49, 0 | 1.619 Log10 copies per milliliter | Standard Deviation 0.1833 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 288; n=30, 38, 45, 0 | 1.591 Log10 copies per milliliter | Standard Deviation 0 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 32; n=52, 53, 55, 45 | 1.618 Log10 copies per milliliter | Standard Deviation 0.1742 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 216; n=33, 39, 47, 0 | 1.634 Log10 copies per milliliter | Standard Deviation 0.2948 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 36; n=52, 53, 55, 45 | 1.606 Log10 copies per milliliter | Standard Deviation 0.0722 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 28; n=51, 52, 52, 45 | 1.591 Log10 copies per milliliter | Standard Deviation 0 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 40; n=52, 53, 55, 45 | 1.608 Log10 copies per milliliter | Standard Deviation 0.0752 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 48; n=51, 53, 54, 44 | 1.598 Log10 copies per milliliter | Standard Deviation 0.0508 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 26; n=48, 50, 53, 44 | 1.594 Log10 copies per milliliter | Standard Deviation 0.0194 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 228; n=32, 39, 47, 0 | 1.625 Log10 copies per milliliter | Standard Deviation 0.2351 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 60; n=48, 48, 53, 44 | 1.594 Log10 copies per milliliter | Standard Deviation 0.0205 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 72; n=47, 48, 52, 42 | 1.591 Log10 copies per milliliter | Standard Deviation 0 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 20; n=56, 54, 56, 47 | 1.599 Log10 copies per milliliter | Standard Deviation 0.0591 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 96; n=45, 48, 52, 40 | 1.596 Log10 copies per milliliter | Standard Deviation 0.0227 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 240; n=31, 39, 45, 0 | 1.591 Log10 copies per milliliter | Standard Deviation 0 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 108; n=43, 46, 49, 0 | 1.591 Log10 copies per milliliter | Standard Deviation 0 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 16; n=57, 54, 57, 52 | 1.616 Log10 copies per milliliter | Standard Deviation 0.0956 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 120; n=41, 46, 49, 0 | 1.618 Log10 copies per milliliter | Standard Deviation 0.1884 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 12; n=58, 52, 57, 51 | 1.641 Log10 copies per milliliter | Standard Deviation 0.2033 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 324; n=3, 4, 3, 0 | 1.591 Log10 copies per milliliter | Standard Deviation 0 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 132; n=40, 46, 49, 0 | 1.591 Log10 copies per milliliter | Standard Deviation 0 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 8; n=59, 56, 57, 55 | 1.666 Log10 copies per milliliter | Standard Deviation 0.3926 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 264; n=32, 38, 47, 0 | 1.617 Log10 copies per milliliter | Standard Deviation 0.1788 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 144; n=37, 45, 47, 0 | 1.630 Log10 copies per milliliter | Standard Deviation 0.2656 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 312; n=31, 33, 43, 0 | 1.591 Log10 copies per milliliter | Standard Deviation 0 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 168; n=35, 43, 47, 0 | 1.603 Log10 copies per milliliter | Standard Deviation 0.081 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 2; n=57, 56, 59, 59 | 1.939 Log10 copies per milliliter | Standard Deviation 0.5071 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 276; n=31, 38, 45, 0 | 1.618 Log10 copies per milliliter | Standard Deviation 0.1398 |
| GSK1265744 60 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 180; n=36, 41, 47, 0 | 1.600 Log10 copies per milliliter | Standard Deviation 0.0584 |
| Efavirenz 600 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 84; n=46, 48, 52, 42 | 1.591 Log10 copies per milliliter | Standard Deviation 0.0017 |
| Efavirenz 600 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Baseline; n=60, 60, 61, 62 | 4.290 Log10 copies per milliliter | Standard Deviation 0.6683 |
| Efavirenz 600 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 60; n=48, 48, 53, 44 | 1.657 Log10 copies per milliliter | Standard Deviation 0.3948 |
| Efavirenz 600 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 16; n=57, 54, 57, 52 | 1.697 Log10 copies per milliliter | Standard Deviation 0.3277 |
| Efavirenz 600 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 32; n=52, 53, 55, 45 | 1.614 Log10 copies per milliliter | Standard Deviation 0.1022 |
| Efavirenz 600 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 28; n=51, 52, 52, 45 | 1.600 Log10 copies per milliliter | Standard Deviation 0.0451 |
| Efavirenz 600 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 48; n=51, 53, 54, 44 | 1.596 Log10 copies per milliliter | Standard Deviation 0.0247 |
| Efavirenz 600 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 12; n=58, 52, 57, 51 | 1.758 Log10 copies per milliliter | Standard Deviation 0.4082 |
| Efavirenz 600 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 24; n=56, 53, 56, 48 | 1.610 Log10 copies per milliliter | Standard Deviation 0.0902 |
| Efavirenz 600 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 36; n=52, 53, 55, 45 | 1.607 Log10 copies per milliliter | Standard Deviation 0.1068 |
| Efavirenz 600 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 20; n=56, 54, 56, 47 | 1.649 Log10 copies per milliliter | Standard Deviation 0.1962 |
| Efavirenz 600 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 96; n=45, 48, 52, 40 | 1.598 Log10 copies per milliliter | Standard Deviation 0.0467 |
| Efavirenz 600 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 72; n=47, 48, 52, 42 | 1.592 Log10 copies per milliliter | Standard Deviation 0.0065 |
| Efavirenz 600 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 40; n=52, 53, 55, 45 | 1.607 Log10 copies per milliliter | Standard Deviation 0.065 |
| Efavirenz 600 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 26; n=48, 50, 53, 44 | 1.610 Log10 copies per milliliter | Standard Deviation 0.0742 |
| Efavirenz 600 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 4; n=58, 57, 59, 57 | 2.201 Log10 copies per milliliter | Standard Deviation 0.578 |
| Efavirenz 600 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 8; n=59, 56, 57, 55 | 1.950 Log10 copies per milliliter | Standard Deviation 0.5636 |
| Efavirenz 600 mg | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit | Week 2; n=57, 56, 59, 59 | 2.415 Log10 copies per milliliter | Standard Deviation 0.5717 |
Secondary
Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96
Blood samples were collected for the analysis of platelet count, total neutrophils (T. neutrophils) and WBC count. Baseline value is the last pre-treatment value observed.
Time frame: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Baseline; n=60, 60, 61, 62 | 212.5 Giga cells per liter | Standard Deviation 53.22 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 96; n=46, 46, 52, 41 | 3.466 Giga cells per liter | Standard Deviation 1.1229 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 84; n=46, 48, 51, 42 | 3.245 Giga cells per liter | Standard Deviation 1.4593 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 16; n=57, 54, 57, 52 | 3.078 Giga cells per liter | Standard Deviation 1.5948 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 24; n=56, 53, 56, 47 | 3.151 Giga cells per liter | Standard Deviation 1.2378 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 72; n=47, 48, 52, 42 | 3.197 Giga cells per liter | Standard Deviation 1.2931 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 60; n=48, 47, 52, 44 | 3.164 Giga cells per liter | Standard Deviation 1.3804 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 20; n=56, 54, 55, 49 | 2.958 Giga cells per liter | Standard Deviation 1.2918 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 12; n=58, 53, 57, 51 | 5.41 Giga cells per liter | Standard Deviation 1.56 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 48; n=51, 53, 54, 44 | 3.138 Giga cells per liter | Standard Deviation 1.3751 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 8; n=58, 56, 56, 55 | 5.44 Giga cells per liter | Standard Deviation 1.751 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 40; n=51, 53, 55, 45 | 3.155 Giga cells per liter | Standard Deviation 1.3417 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 36; n=52, 53, 55, 44 | 3.162 Giga cells per liter | Standard Deviation 1.1538 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 26; n=48, 50, 53, 45 | 2.885 Giga cells per liter | Standard Deviation 1.0874 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 26; n=48, 50, 53, 45 | 5.30 Giga cells per liter | Standard Deviation 1.294 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 32; n=51, 53, 55, 45 | 2.797 Giga cells per liter | Standard Deviation 0.949 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 28; n=50, 52, 52, 45 | 3.183 Giga cells per liter | Standard Deviation 1.0674 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 4; n=57, 57, 59, 57 | 5.24 Giga cells per liter | Standard Deviation 1.802 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 2; n=57, 56, 59, 59 | 5.32 Giga cells per liter | Standard Deviation 1.602 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 40; n=51, 53, 55, 45 | 5.63 Giga cells per liter | Standard Deviation 1.607 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Baseline; n=60, 60, 61, 62 | 5.06 Giga cells per liter | Standard Deviation 1.552 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 48; n=51, 53, 54, 44 | 5.51 Giga cells per liter | Standard Deviation 1.663 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 24; n=56, 53, 56, 47 | 5.57 Giga cells per liter | Standard Deviation 1.558 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 84; n=46, 48, 51, 42 | 224.8 Giga cells per liter | Standard Deviation 52.36 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 72; n=47, 48, 52, 42 | 234.0 Giga cells per liter | Standard Deviation 52.53 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 60; n=48, 47, 52, 44 | 5.73 Giga cells per liter | Standard Deviation 1.749 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 20; n=56, 54, 55, 49 | 5.46 Giga cells per liter | Standard Deviation 1.486 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Baseline; n=60, 60, 61, 62 | 2.643 Giga cells per liter | Standard Deviation 1.1237 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 60; n=48, 47, 51, 44 | 232.5 Giga cells per liter | Standard Deviation 57 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 96; n=46, 45, 51, 41 | 237.1 Giga cells per liter | Standard Deviation 58.94 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 48; n=51, 52, 53, 44 | 225.6 Giga cells per liter | Standard Deviation 60.05 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 40; n=51, 53, 54, 45 | 224.9 Giga cells per liter | Standard Deviation 52.93 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 36; n=52, 53, 55, 44 | 220.0 Giga cells per liter | Standard Deviation 47.58 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 2; n=57, 56, 59, 59 | 2.723 Giga cells per liter | Standard Deviation 1.1402 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 32; n=51, 52, 55, 45 | 220.5 Giga cells per liter | Standard Deviation 55.37 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 36; n=52, 53, 55, 44 | 5.64 Giga cells per liter | Standard Deviation 1.461 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 28; n=50, 52, 52, 45 | 223.3 Giga cells per liter | Standard Deviation 50.28 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 26; n=48, 50, 53, 45 | 224.9 Giga cells per liter | Standard Deviation 56.06 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 4; n=57, 57, 59, 57 | 2.685 Giga cells per liter | Standard Deviation 1.2477 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 24; n=56, 53, 56, 47 | 226.1 Giga cells per liter | Standard Deviation 52.17 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 84; n=46, 48, 51, 42 | 5.91 Giga cells per liter | Standard Deviation 1.845 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 32; n=51, 53, 55, 45 | 5.30 Giga cells per liter | Standard Deviation 1.399 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 20; n=56, 54, 55, 49 | 231.3 Giga cells per liter | Standard Deviation 55.14 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 8; n=58, 56, 56, 55 | 2.899 Giga cells per liter | Standard Deviation 1.2111 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 16; n=57, 54, 57, 52 | 5.56 Giga cells per liter | Standard Deviation 1.895 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 16; n=57, 54, 57, 52 | 230.0 Giga cells per liter | Standard Deviation 59.33 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 12; n=58, 53, 57, 51 | 227.2 Giga cells per liter | Standard Deviation 49.64 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 8; n=58, 56, 56, 55 | 224.5 Giga cells per liter | Standard Deviation 50.94 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 12; n=58, 53, 57, 51 | 2.812 Giga cells per liter | Standard Deviation 1.1377 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 4; n=57, 57, 59, 57 | 225.2 Giga cells per liter | Standard Deviation 52.94 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 72; n=47, 48, 52, 42 | 5.80 Giga cells per liter | Standard Deviation 1.671 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 96; n=46, 46, 52, 41 | 6.14 Giga cells per liter | Standard Deviation 1.622 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 28; n=50, 52, 52, 45 | 5.71 Giga cells per liter | Standard Deviation 1.426 |
| GSK1265744 10 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 2; n=57, 56, 59, 59 | 225.0 Giga cells per liter | Standard Deviation 54.84 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 4; n=57, 57, 59, 57 | 2.771 Giga cells per liter | Standard Deviation 1.2587 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 40; n=51, 53, 55, 45 | 5.61 Giga cells per liter | Standard Deviation 1.687 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 72; n=47, 48, 52, 42 | 5.71 Giga cells per liter | Standard Deviation 1.55 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 32; n=51, 53, 55, 45 | 5.63 Giga cells per liter | Standard Deviation 1.456 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 36; n=52, 53, 55, 44 | 5.48 Giga cells per liter | Standard Deviation 1.756 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 48; n=51, 53, 54, 44 | 5.72 Giga cells per liter | Standard Deviation 1.695 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 60; n=48, 47, 52, 44 | 5.93 Giga cells per liter | Standard Deviation 1.677 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Baseline; n=60, 60, 61, 62 | 2.891 Giga cells per liter | Standard Deviation 1.4383 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 2; n=57, 56, 59, 59 | 2.776 Giga cells per liter | Standard Deviation 1.0729 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 84; n=46, 48, 51, 42 | 6.11 Giga cells per liter | Standard Deviation 1.718 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 8; n=58, 56, 56, 55 | 2.802 Giga cells per liter | Standard Deviation 1.1296 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 12; n=58, 53, 57, 51 | 2.933 Giga cells per liter | Standard Deviation 1.5977 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 96; n=46, 46, 52, 41 | 6.15 Giga cells per liter | Standard Deviation 1.933 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 16; n=57, 54, 57, 52 | 2.716 Giga cells per liter | Standard Deviation 1.1022 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 20; n=56, 54, 55, 49 | 2.904 Giga cells per liter | Standard Deviation 1.1794 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 24; n=56, 53, 56, 47 | 2.996 Giga cells per liter | Standard Deviation 1.5425 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 26; n=48, 50, 53, 45 | 2.958 Giga cells per liter | Standard Deviation 1.2097 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 28; n=50, 52, 52, 45 | 3.005 Giga cells per liter | Standard Deviation 1.0029 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 32; n=51, 53, 55, 45 | 3.036 Giga cells per liter | Standard Deviation 1.1931 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 36; n=52, 53, 55, 44 | 2.916 Giga cells per liter | Standard Deviation 1.2331 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 40; n=51, 53, 55, 45 | 3.065 Giga cells per liter | Standard Deviation 1.2945 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 48; n=51, 53, 54, 44 | 3.132 Giga cells per liter | Standard Deviation 1.1976 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 60; n=48, 47, 52, 44 | 3.333 Giga cells per liter | Standard Deviation 1.5642 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 72; n=47, 48, 52, 42 | 3.131 Giga cells per liter | Standard Deviation 1.2337 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 84; n=46, 48, 51, 42 | 3.385 Giga cells per liter | Standard Deviation 1.3591 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 96; n=46, 46, 52, 41 | 3.540 Giga cells per liter | Standard Deviation 1.787 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Baseline; n=60, 60, 61, 62 | 202.3 Giga cells per liter | Standard Deviation 51.74 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 2; n=57, 56, 59, 59 | 222.0 Giga cells per liter | Standard Deviation 48.82 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 4; n=57, 57, 59, 57 | 222.4 Giga cells per liter | Standard Deviation 52.61 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 8; n=58, 56, 56, 55 | 228.4 Giga cells per liter | Standard Deviation 57.01 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 12; n=58, 53, 57, 51 | 216.4 Giga cells per liter | Standard Deviation 52.46 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 16; n=57, 54, 57, 52 | 212.4 Giga cells per liter | Standard Deviation 54.22 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 20; n=56, 54, 55, 49 | 215.5 Giga cells per liter | Standard Deviation 47.03 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 24; n=56, 53, 56, 47 | 219.7 Giga cells per liter | Standard Deviation 50.75 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 26; n=48, 50, 53, 45 | 215.5 Giga cells per liter | Standard Deviation 53.1 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 28; n=50, 52, 52, 45 | 217.0 Giga cells per liter | Standard Deviation 56.54 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 32; n=51, 52, 55, 45 | 214.0 Giga cells per liter | Standard Deviation 46.66 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 36; n=52, 53, 55, 44 | 212.1 Giga cells per liter | Standard Deviation 51.61 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 40; n=51, 53, 54, 45 | 210.1 Giga cells per liter | Standard Deviation 55.87 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 48; n=51, 52, 53, 44 | 221.2 Giga cells per liter | Standard Deviation 56.12 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 60; n=48, 47, 51, 44 | 219.8 Giga cells per liter | Standard Deviation 55.01 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 72; n=47, 48, 52, 42 | 224.4 Giga cells per liter | Standard Deviation 50.06 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 84; n=46, 48, 51, 42 | 218.8 Giga cells per liter | Standard Deviation 49.15 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 96; n=46, 45, 51, 41 | 221.8 Giga cells per liter | Standard Deviation 57.95 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Baseline; n=60, 60, 61, 62 | 5.19 Giga cells per liter | Standard Deviation 1.632 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 2; n=57, 56, 59, 59 | 5.30 Giga cells per liter | Standard Deviation 1.448 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 4; n=57, 57, 59, 57 | 5.17 Giga cells per liter | Standard Deviation 1.604 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 8; n=58, 56, 56, 55 | 5.30 Giga cells per liter | Standard Deviation 1.556 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 12; n=58, 53, 57, 51 | 5.50 Giga cells per liter | Standard Deviation 1.794 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 16; n=57, 54, 57, 52 | 5.20 Giga cells per liter | Standard Deviation 1.337 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 20; n=56, 54, 55, 49 | 5.41 Giga cells per liter | Standard Deviation 1.354 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 24; n=56, 53, 56, 47 | 5.53 Giga cells per liter | Standard Deviation 1.993 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 26; n=48, 50, 53, 45 | 5.50 Giga cells per liter | Standard Deviation 1.642 |
| GSK1265744 30 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 28; n=50, 52, 52, 45 | 5.53 Giga cells per liter | Standard Deviation 1.493 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 24; n=56, 53, 56, 47 | 210.9 Giga cells per liter | Standard Deviation 56.34 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 60; n=48, 47, 51, 44 | 212.2 Giga cells per liter | Standard Deviation 53.68 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 4; n=57, 57, 59, 57 | 204.6 Giga cells per liter | Standard Deviation 57.51 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 12; n=58, 53, 57, 51 | 209.2 Giga cells per liter | Standard Deviation 51.62 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 96; n=46, 46, 52, 41 | 6.01 Giga cells per liter | Standard Deviation 1.489 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 72; n=47, 48, 52, 42 | 212.2 Giga cells per liter | Standard Deviation 52.59 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 26; n=48, 50, 53, 45 | 199.4 Giga cells per liter | Standard Deviation 60.65 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 48; n=51, 53, 54, 44 | 5.41 Giga cells per liter | Standard Deviation 1.314 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 28; n=50, 52, 52, 45 | 5.38 Giga cells per liter | Standard Deviation 1.542 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 84; n=46, 48, 51, 42 | 210.1 Giga cells per liter | Standard Deviation 51.72 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 24; n=56, 53, 56, 47 | 5.28 Giga cells per liter | Standard Deviation 1.367 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 96; n=46, 45, 51, 41 | 210.6 Giga cells per liter | Standard Deviation 57.34 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 8; n=58, 56, 56, 55 | 2.738 Giga cells per liter | Standard Deviation 1.1533 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 2; n=57, 56, 59, 59 | 2.598 Giga cells per liter | Standard Deviation 1.1295 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 16; n=57, 54, 57, 52 | 4.97 Giga cells per liter | Standard Deviation 1.108 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Baseline; n=60, 60, 61, 62 | 4.72 Giga cells per liter | Standard Deviation 1.332 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 28; n=50, 52, 52, 45 | 209.8 Giga cells per liter | Standard Deviation 56.65 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 12; n=58, 53, 57, 51 | 5.34 Giga cells per liter | Standard Deviation 1.524 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 72; n=47, 48, 52, 42 | 5.73 Giga cells per liter | Standard Deviation 1.297 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 28; n=50, 52, 52, 45 | 2.989 Giga cells per liter | Standard Deviation 1.4078 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 16; n=57, 54, 57, 52 | 209.5 Giga cells per liter | Standard Deviation 50.32 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 26; n=48, 50, 53, 45 | 2.830 Giga cells per liter | Standard Deviation 1.0354 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 48; n=51, 53, 54, 44 | 3.004 Giga cells per liter | Standard Deviation 1.172 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 32; n=51, 53, 55, 45 | 3.167 Giga cells per liter | Standard Deviation 1.3992 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 32; n=51, 52, 55, 45 | 207.8 Giga cells per liter | Standard Deviation 53.33 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 84; n=46, 48, 51, 42 | 6.05 Giga cells per liter | Standard Deviation 1.469 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 2; n=57, 56, 59, 59 | 5.02 Giga cells per liter | Standard Deviation 1.355 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 36; n=52, 53, 55, 44 | 3.010 Giga cells per liter | Standard Deviation 1.0698 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 32; n=51, 53, 55, 45 | 5.57 Giga cells per liter | Standard Deviation 1.72 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 24; n=56, 53, 56, 47 | 2.884 Giga cells per liter | Standard Deviation 1.0047 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 8; n=58, 56, 56, 55 | 211.5 Giga cells per liter | Standard Deviation 56.8 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 40; n=51, 53, 55, 45 | 3.050 Giga cells per liter | Standard Deviation 1.0745 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 36; n=52, 53, 55, 44 | 204.2 Giga cells per liter | Standard Deviation 54.34 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 20; n=56, 54, 55, 49 | 2.989 Giga cells per liter | Standard Deviation 1.6589 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 36; n=52, 53, 55, 44 | 5.56 Giga cells per liter | Standard Deviation 1.303 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 20; n=56, 54, 55, 49 | 205.4 Giga cells per liter | Standard Deviation 48.4 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 8; n=58, 56, 56, 55 | 5.04 Giga cells per liter | Standard Deviation 1.23 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 60; n=48, 47, 52, 44 | 3.200 Giga cells per liter | Standard Deviation 1.2159 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 4; n=57, 57, 59, 57 | 2.649 Giga cells per liter | Standard Deviation 1.0692 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 16; n=57, 54, 57, 52 | 2.665 Giga cells per liter | Standard Deviation 1.0287 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 4; n=57, 57, 59, 57 | 5.02 Giga cells per liter | Standard Deviation 1.342 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 72; n=47, 48, 52, 42 | 3.163 Giga cells per liter | Standard Deviation 1.0874 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 40; n=51, 53, 54, 45 | 199.3 Giga cells per liter | Standard Deviation 52.37 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 2; n=57, 56, 59, 59 | 204.8 Giga cells per liter | Standard Deviation 50.51 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Baseline; n=60, 60, 61, 62 | 2.487 Giga cells per liter | Standard Deviation 1.024 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 84; n=46, 48, 51, 42 | 3.512 Giga cells per liter | Standard Deviation 1.3176 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 20; n=56, 54, 55, 49 | 5.39 Giga cells per liter | Standard Deviation 1.877 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 12; n=58, 53, 57, 51 | 2.822 Giga cells per liter | Standard Deviation 1.3294 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 48; n=51, 52, 53, 44 | 209.9 Giga cells per liter | Standard Deviation 56.81 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 96; n=46, 46, 52, 41 | 3.494 Giga cells per liter | Standard Deviation 1.279 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 40; n=51, 53, 55, 45 | 5.45 Giga cells per liter | Standard Deviation 1.255 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 60; n=48, 47, 52, 44 | 5.63 Giga cells per liter | Standard Deviation 1.491 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 26; n=48, 50, 53, 45 | 5.29 Giga cells per liter | Standard Deviation 1.315 |
| GSK1265744 60 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Baseline; n=60, 60, 61, 62 | 190.0 Giga cells per liter | Standard Deviation 55.71 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 40; n=51, 53, 55, 45 | 5.51 Giga cells per liter | Standard Deviation 1.808 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 2; n=57, 56, 59, 59 | 216.2 Giga cells per liter | Standard Deviation 52.6 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 84; n=46, 48, 51, 42 | 5.78 Giga cells per liter | Standard Deviation 1.658 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 8; n=58, 56, 56, 55 | 5.02 Giga cells per liter | Standard Deviation 1.195 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 4; n=57, 57, 59, 57 | 216.0 Giga cells per liter | Standard Deviation 55.41 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 8; n=58, 56, 56, 55 | 209.8 Giga cells per liter | Standard Deviation 48.62 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 8; n=58, 56, 56, 55 | 2.746 Giga cells per liter | Standard Deviation 0.9969 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 26; n=48, 50, 53, 45 | 5.08 Giga cells per liter | Standard Deviation 1.381 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 12; n=58, 53, 57, 51 | 213.7 Giga cells per liter | Standard Deviation 50.65 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 16; n=57, 54, 57, 52 | 211.4 Giga cells per liter | Standard Deviation 50.56 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 4; n=57, 57, 59, 57 | 2.848 Giga cells per liter | Standard Deviation 1.8642 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 12; n=58, 53, 57, 51 | 5.27 Giga cells per liter | Standard Deviation 1.899 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 20; n=56, 54, 55, 49 | 214.9 Giga cells per liter | Standard Deviation 51.41 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 72; n=47, 48, 52, 42 | 5.84 Giga cells per liter | Standard Deviation 2.104 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 24; n=56, 53, 56, 47 | 220.9 Giga cells per liter | Standard Deviation 67.67 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 2; n=57, 56, 59, 59 | 3.207 Giga cells per liter | Standard Deviation 1.6307 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 20; n=56, 54, 55, 49 | 3.187 Giga cells per liter | Standard Deviation 1.6424 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 26; n=48, 50, 53, 45 | 214.4 Giga cells per liter | Standard Deviation 53.9 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 28; n=50, 52, 52, 45 | 215.4 Giga cells per liter | Standard Deviation 57.81 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 16; n=57, 54, 57, 52 | 5.13 Giga cells per liter | Standard Deviation 1.48 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 32; n=51, 52, 55, 45 | 212.6 Giga cells per liter | Standard Deviation 52.27 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Baseline; n=60, 60, 61, 62 | 2.441 Giga cells per liter | Standard Deviation 1.1548 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 84; n=46, 48, 51, 42 | 216.5 Giga cells per liter | Standard Deviation 53.09 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 36; n=52, 53, 55, 44 | 209.8 Giga cells per liter | Standard Deviation 52.54 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 60; n=48, 47, 52, 44 | 5.75 Giga cells per liter | Standard Deviation 1.608 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 40; n=51, 53, 54, 45 | 217.7 Giga cells per liter | Standard Deviation 54.4 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 48; n=51, 52, 53, 44 | 220.3 Giga cells per liter | Standard Deviation 52.52 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 20; n=56, 54, 55, 49 | 5.50 Giga cells per liter | Standard Deviation 1.763 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 60; n=48, 47, 51, 44 | 230.5 Giga cells per liter | Standard Deviation 56.39 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 48; n=51, 53, 54, 44 | 5.53 Giga cells per liter | Standard Deviation 1.818 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 48; n=51, 53, 54, 44 | 3.134 Giga cells per liter | Standard Deviation 1.6646 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 72; n=47, 48, 52, 42 | 225.9 Giga cells per liter | Standard Deviation 52.62 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Week 96; n=46, 45, 51, 41 | 214.0 Giga cells per liter | Standard Deviation 51.1 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | Platelet count; Baseline; n=60, 60, 61, 62 | 200.1 Giga cells per liter | Standard Deviation 52.36 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 24; n=56, 53, 56, 47 | 5.34 Giga cells per liter | Standard Deviation 1.854 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Baseline; n=60, 60, 61, 62 | 4.70 Giga cells per liter | Standard Deviation 1.388 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 26; n=48, 50, 53, 45 | 2.886 Giga cells per liter | Standard Deviation 1.3159 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 36; n=52, 53, 55, 44 | 5.17 Giga cells per liter | Standard Deviation 1.312 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 28; n=50, 52, 52, 45 | 2.916 Giga cells per liter | Standard Deviation 1.0731 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 32; n=51, 53, 55, 45 | 3.174 Giga cells per liter | Standard Deviation 1.715 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 24; n=56, 53, 56, 47 | 3.142 Giga cells per liter | Standard Deviation 1.6483 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 36; n=52, 53, 55, 44 | 2.914 Giga cells per liter | Standard Deviation 1.253 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 2; n=57, 56, 59, 59 | 5.45 Giga cells per liter | Standard Deviation 1.856 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 40; n=51, 53, 55, 45 | 3.187 Giga cells per liter | Standard Deviation 1.6006 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 16; n=57, 54, 57, 52 | 2.858 Giga cells per liter | Standard Deviation 1.1909 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 28; n=50, 52, 52, 45 | 5.14 Giga cells per liter | Standard Deviation 1.254 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 60; n=48, 47, 52, 44 | 3.269 Giga cells per liter | Standard Deviation 1.3866 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 72; n=47, 48, 52, 42 | 3.361 Giga cells per liter | Standard Deviation 1.8047 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 12; n=58, 53, 57, 51 | 2.979 Giga cells per liter | Standard Deviation 1.7673 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 4; n=57, 57, 59, 57 | 5.02 Giga cells per liter | Standard Deviation 1.993 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 84; n=46, 48, 51, 42 | 3.259 Giga cells per liter | Standard Deviation 1.6532 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 32; n=51, 53, 55, 45 | 5.48 Giga cells per liter | Standard Deviation 1.939 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | T. neutrophils; Week 96; n=46, 46, 52, 41 | 3.297 Giga cells per liter | Standard Deviation 1.4509 |
| Efavirenz 600 mg | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 | WBC count; Week 96; n=46, 46, 52, 41 | 5.75 Giga cells per liter | Standard Deviation 1.556 |
Secondary
Area Under the Concentration Time Curve Over the Dosing Interval (AUC[0-tau]) for GSK1265744 at Week 2
Blood samples for pharmacokinetic (PK) analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. The PK Summary Population comprised of all participants who received GSK1265744 or with Rilpivirine, underwent intensive and/or limited/sparse PK sampling during the study, and provided evaluable GSK1265744 and Rilpivirine plasma concentration data
Time frame: pre-dose, 1, 2, 3, 4, 8 and 24 hours post-dose at Week 2
Population: PK Summary Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| GSK1265744 10 mg | Area Under the Concentration Time Curve Over the Dosing Interval (AUC[0-tau]) for GSK1265744 at Week 2 | 45.69 Hours*micrograms per milliliter | Geometric Coefficient of Variation 32 |
| GSK1265744 30 mg | Area Under the Concentration Time Curve Over the Dosing Interval (AUC[0-tau]) for GSK1265744 at Week 2 | 133.74 Hours*micrograms per milliliter | Geometric Coefficient of Variation 32 |
| GSK1265744 60 mg | Area Under the Concentration Time Curve Over the Dosing Interval (AUC[0-tau]) for GSK1265744 at Week 2 | 227.58 Hours*micrograms per milliliter | Geometric Coefficient of Variation 57 |
Secondary
AUC(0 to Tau) for Rilpivirine
Data was not collected for analysis of rilpivirine PK parameters.
Time frame: pre-dose and 2 to 4 hours post-dose at Weeks 26 and 36
Population: PK Summary Population. Data were not collected for rilpivirine PK parameters since this drug has been approved already for treatment and the PK of the drug has been well characterized
Secondary
Change From Baseline in ALT, AST and CK Over Time by Visit
Blood samples were collected for the analysis of ALT, AST and CK. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
Time frame: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Population: Safety Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 264; n=32, 38, 47, 0 | 3.3 International Units per Liter | Standard Deviation 19.88 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 144; n=37, 45, 47, 0 | 10.6 International Units per Liter | Standard Deviation 143.04 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 192; n=36, 39, 47, 0 | -1.5 International Units per Liter | Standard Deviation 8.89 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 276; n=31, 38, 45, 0 | 3.3 International Units per Liter | Standard Deviation 19.97 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 180; n=36, 41, 47, 0 | -1.9 International Units per Liter | Standard Deviation 7.91 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 288; n=31, 38, 45, 0 | 6.6 International Units per Liter | Standard Deviation 24.89 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 132; n=40, 46, 49, 0 | 30.6 International Units per Liter | Standard Deviation 198.34 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 168; n=35, 43, 47, 0 | -0.8 International Units per Liter | Standard Deviation 8.95 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 300; n=30, 37, 44, 0 | 4.8 International Units per Liter | Standard Deviation 25.46 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 24; n=56, 53, 56, 47 | -2.1 International Units per Liter | Standard Deviation 7.93 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 156; n=37, 42, 49, 0 | -3.0 International Units per Liter | Standard Deviation 8.78 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 312; n=31, 34, 43, 0 | 5.5 International Units per Liter | Standard Deviation 25.29 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 2; n=58, 56, 58, 58 | 0.1 International Units per Liter | Standard Deviation 7.47 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 144; n=37, 45, 47, 0 | -3.4 International Units per Liter | Standard Deviation 8.19 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 324; n=3, 4, 3, 0 | 17.7 International Units per Liter | Standard Deviation 40.15 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 120; n=40, 45, 48, 0 | 11.5 International Units per Liter | Standard Deviation 229.39 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 132; n=40, 46, 49, 0 | -0.2 International Units per Liter | Standard Deviation 11.5 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 2; n=58, 56, 58, 58 | 0.7 International Units per Liter | Standard Deviation 6.11 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 108; n=43, 46, 48, 0 | 64.2 International Units per Liter | Standard Deviation 339.96 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 120; n=40, 45, 48, 0 | 0.1 International Units per Liter | Standard Deviation 13.16 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 108; n=43, 46, 48, 0 | -1.0 International Units per Liter | Standard Deviation 10.89 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 4; n=58, 57, 59, 57 | -1.0 International Units per Liter | Standard Deviation 5.96 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 26; n=48, 50, 53, 45 | 1.1 International Units per Liter | Standard Deviation 16.32 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 96; n=45, 48, 52, 40 | -0.8 International Units per Liter | Standard Deviation 22.39 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 84; n=46, 48, 52, 42 | -2.2 International Units per Liter | Standard Deviation 7.56 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 8; n=58, 55, 57, 54 | 4.2 International Units per Liter | Standard Deviation 30.51 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 300; n=30, 37, 44, 0 | 25.3 International Units per Liter | Standard Deviation 129.65 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 72; n=47, 47, 52, 42 | -2.7 International Units per Liter | Standard Deviation 6.7 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 60; n=48, 47, 53, 44 | -0.9 International Units per Liter | Standard Deviation 9.05 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 12; n=58, 53, 57, 50 | 1.3 International Units per Liter | Standard Deviation 10.43 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 96; n=45, 48, 52, 40 | 335.4 International Units per Liter | Standard Deviation 2431.93 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 48; n=51, 53, 54, 44 | -3.3 International Units per Liter | Standard Deviation 7.99 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 40; n=52, 53, 55, 44 | 0.1 International Units per Liter | Standard Deviation 13.12 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 16; n=57, 54, 57, 52 | -0.7 International Units per Liter | Standard Deviation 10.43 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 84; n=46, 48, 52, 42 | -0.7 International Units per Liter | Standard Deviation 147.67 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 36; n=52, 52, 55, 45 | 4.6 International Units per Liter | Standard Deviation 38.77 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 32; n=52, 53, 55, 45 | -2.7 International Units per Liter | Standard Deviation 5.77 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 20; n=56, 54, 55, 49 | 1.3 International Units per Liter | Standard Deviation 18.94 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 28; n=51, 52, 52, 45 | -2.3 International Units per Liter | Standard Deviation 7.87 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 28; n=51, 52, 52, 45 | -2.0 International Units per Liter | Standard Deviation 6.39 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 26; n=48, 50, 53, 45 | 3.3 International Units per Liter | Standard Deviation 28.47 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 24; n=56, 53, 56, 47 | -1.4 International Units per Liter | Standard Deviation 7.81 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 264; n=32, 38, 47, 0 | 1.9 International Units per Liter | Standard Deviation 135.22 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 72; n=47, 47, 52, 42 | -19.8 International Units per Liter | Standard Deviation 152.46 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 60; n=48, 47, 53, 44 | 115.4 International Units per Liter | Standard Deviation 743.67 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 32; n=52, 53, 55, 45 | -3.1 International Units per Liter | Standard Deviation 8.55 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 48; n=51, 53, 54, 44 | -1.3 International Units per Liter | Standard Deviation 173.8 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 36; n=52, 52, 55, 45 | 0.8 International Units per Liter | Standard Deviation 23.68 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 252; n=31, 38, 46, 0 | 24.6 International Units per Liter | Standard Deviation 96.4 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 40; n=52, 53, 55, 44 | 57.1 International Units per Liter | Standard Deviation 350.15 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 36; n=52, 52, 55, 45 | 325.9 International Units per Liter | Standard Deviation 1995.64 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 40; n=52, 53, 55, 44 | 0.1 International Units per Liter | Standard Deviation 15.48 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 4; n=58, 57, 59, 57 | -0.7 International Units per Liter | Standard Deviation 8.94 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 32; n=52, 53, 55, 45 | 3.1 International Units per Liter | Standard Deviation 159.46 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 28; n=51, 52, 52, 45 | 9.8 International Units per Liter | Standard Deviation 179.35 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 48; n=51, 53, 54, 44 | -4.1 International Units per Liter | Standard Deviation 9.03 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 288; n=31, 38, 45, 0 | 21.6 International Units per Liter | Standard Deviation 139.26 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 60; n=48, 47, 53, 44 | -1.0 International Units per Liter | Standard Deviation 15.72 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 240; n=30, 39, 46, 0 | 1.2 International Units per Liter | Standard Deviation 118.21 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 26; n=48, 50, 53, 45 | 133.7 International Units per Liter | Standard Deviation 612.97 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 24; n=56, 53, 56, 47 | 27.5 International Units per Liter | Standard Deviation 241.96 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 72; n=47, 47, 52, 42 | -2.8 International Units per Liter | Standard Deviation 9.92 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 228; n=32, 39, 47, 0 | 64.0 International Units per Liter | Standard Deviation 332.07 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 20; n=56, 54, 55, 49 | 144.2 International Units per Liter | Standard Deviation 969.11 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 84; n=46, 48, 52, 42 | -2.4 International Units per Liter | Standard Deviation 10.87 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 8; n=58, 55, 57, 54 | 2.2 International Units per Liter | Standard Deviation 10.71 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 16; n=57, 54, 57, 52 | -2.0 International Units per Liter | Standard Deviation 177.01 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 12; n=58, 53, 57, 51 | 120.6 International Units per Liter | Standard Deviation 551.72 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 96; n=45, 48, 52, 40 | -0.4 International Units per Liter | Standard Deviation 18.47 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 276; n=31, 38, 45, 0 | 39.9 International Units per Liter | Standard Deviation 258.45 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 8; n=58, 55, 57, 54 | 216.9 International Units per Liter | Standard Deviation 1495.44 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 4; n=58, 57, 59, 57 | -2.3 International Units per Liter | Standard Deviation 125.78 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 108; n=43, 46, 48, 0 | 0.5 International Units per Liter | Standard Deviation 11.41 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 216; n=33, 39, 46, 0 | 43.2 International Units per Liter | Standard Deviation 232.12 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 2; n=58, 56, 58, 58 | 40.0 International Units per Liter | Standard Deviation 234.19 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 120; n=40, 45, 48, 0 | 4.4 International Units per Liter | Standard Deviation 23.14 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 204; n=34, 39, 47, 0 | 79.1 International Units per Liter | Standard Deviation 253.58 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 324; n=3, 4, 3, 0 | 2.7 International Units per Liter | Standard Deviation 12.66 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 132; n=40, 46, 49, 0 | 4.3 International Units per Liter | Standard Deviation 23.58 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 12; n=58, 53, 57, 51 | 1.2 International Units per Liter | Standard Deviation 8.91 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 312; n=31, 34, 43, 0 | 11.7 International Units per Liter | Standard Deviation 82.61 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 156; n=37, 42, 49, 0 | -0.5 International Units per Liter | Standard Deviation 13.86 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 144; n=37, 45, 47, 0 | 0.1 International Units per Liter | Standard Deviation 13.01 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 300; n=30, 37, 44, 0 | -2.0 International Units per Liter | Standard Deviation 9.56 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 168; n=35, 43, 47, 0 | 2.3 International Units per Liter | Standard Deviation 11.4 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 192; n=36, 39, 47, 0 | 5.2 International Units per Liter | Standard Deviation 123.98 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 288; n=31, 38, 45, 0 | -1.4 International Units per Liter | Standard Deviation 11.87 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 180; n=36, 41, 47, 0 | 1.7 International Units per Liter | Standard Deviation 12.96 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 180; n=36, 41, 47, 0 | 22.4 International Units per Liter | Standard Deviation 120.72 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 276; n=31, 38, 45, 0 | -1.5 International Units per Liter | Standard Deviation 10 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 192; n=36, 39, 47, 0 | 4.9 International Units per Liter | Standard Deviation 17.56 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 16; n=57, 54, 57, 52 | 2.1 International Units per Liter | Standard Deviation 19.92 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 264; n=32, 38, 47, 0 | -1.6 International Units per Liter | Standard Deviation 10.61 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 204; n=34, 39, 47, 0 | 1.9 International Units per Liter | Standard Deviation 11.42 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 324; n=3, 4, 3, 0 | -1.3 International Units per Liter | Standard Deviation 168.42 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 252; n=31, 38, 46, 0 | -2.2 International Units per Liter | Standard Deviation 10.89 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 216; n=33, 39, 46, 0 | 1.7 International Units per Liter | Standard Deviation 11.28 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 168; n=35, 43, 47, 0 | 27.7 International Units per Liter | Standard Deviation 149.18 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 240; n=30, 39, 46, 0 | -1.0 International Units per Liter | Standard Deviation 21.51 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 228; n=32, 39, 47, 0 | 36.8 International Units per Liter | Standard Deviation 162.51 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 156; n=37, 42, 49, 0 | -5.3 International Units per Liter | Standard Deviation 178.55 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 228; n=32, 39, 47, 0 | 13.5 International Units per Liter | Standard Deviation 72.97 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 240; n=30, 39, 46, 0 | 5.3 International Units per Liter | Standard Deviation 38.37 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 20; n=56, 54, 55, 49 | -0.7 International Units per Liter | Standard Deviation 8.58 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 216; n=33, 39, 46, 0 | -2.7 International Units per Liter | Standard Deviation 6.4 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 252; n=31, 38, 46, 0 | 2.0 International Units per Liter | Standard Deviation 18.06 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 312; n=31, 34, 43, 0 | 727.5 International Units per Liter | Standard Deviation 4047.61 |
| GSK1265744 10 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 204; n=34, 39, 47, 0 | -1.7 International Units per Liter | Standard Deviation 7.88 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 144; n=37, 45, 47, 0 | -72.4 International Units per Liter | Standard Deviation 637.65 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 144; n=37, 45, 47, 0 | -3.4 International Units per Liter | Standard Deviation 17.81 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 276; n=31, 38, 45, 0 | 2.9 International Units per Liter | Standard Deviation 31.3 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 2; n=58, 56, 58, 58 | -2.1 International Units per Liter | Standard Deviation 12.74 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 4; n=58, 57, 59, 57 | -2.6 International Units per Liter | Standard Deviation 12.13 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 8; n=58, 55, 57, 54 | 0.5 International Units per Liter | Standard Deviation 18.49 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 12; n=58, 53, 57, 51 | 2.7 International Units per Liter | Standard Deviation 24.7 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 16; n=57, 54, 57, 52 | 0.1 International Units per Liter | Standard Deviation 27.07 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 20; n=56, 54, 55, 49 | -3.6 International Units per Liter | Standard Deviation 14.07 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 24; n=56, 53, 56, 47 | -1.2 International Units per Liter | Standard Deviation 20.79 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 26; n=48, 50, 53, 45 | -2.6 International Units per Liter | Standard Deviation 24.31 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 28; n=51, 52, 52, 45 | -2.3 International Units per Liter | Standard Deviation 25.4 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 36; n=52, 52, 55, 45 | -4.2 International Units per Liter | Standard Deviation 17.84 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 40; n=52, 53, 55, 44 | -4.1 International Units per Liter | Standard Deviation 15.85 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 48; n=51, 53, 54, 44 | -3.8 International Units per Liter | Standard Deviation 17.77 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 60; n=48, 47, 53, 44 | -2.6 International Units per Liter | Standard Deviation 17.74 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 72; n=47, 47, 52, 42 | 2.7 International Units per Liter | Standard Deviation 30.95 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 84; n=46, 48, 52, 42 | 1.9 International Units per Liter | Standard Deviation 22.6 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 96; n=45, 48, 52, 40 | 20.6 International Units per Liter | Standard Deviation 154.71 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 108; n=43, 46, 48, 0 | -2.7 International Units per Liter | Standard Deviation 20.04 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 120; n=40, 45, 48, 0 | -2.6 International Units per Liter | Standard Deviation 18.42 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 132; n=40, 46, 49, 0 | -3.0 International Units per Liter | Standard Deviation 20.18 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 156; n=37, 42, 49, 0 | -1.8 International Units per Liter | Standard Deviation 19.51 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 168; n=35, 43, 47, 0 | -1.1 International Units per Liter | Standard Deviation 19.14 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 180; n=36, 41, 47, 0 | -2.8 International Units per Liter | Standard Deviation 15.68 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 192; n=36, 39, 47, 0 | -3.3 International Units per Liter | Standard Deviation 16.07 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 204; n=34, 39, 47, 0 | -1.7 International Units per Liter | Standard Deviation 16.25 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 216; n=33, 39, 46, 0 | -3.0 International Units per Liter | Standard Deviation 13.37 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 228; n=32, 39, 47, 0 | -1.1 International Units per Liter | Standard Deviation 13.68 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 240; n=30, 39, 46, 0 | -0.1 International Units per Liter | Standard Deviation 16.56 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 252; n=31, 38, 46, 0 | 2.8 International Units per Liter | Standard Deviation 22.54 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 264; n=32, 38, 47, 0 | 0.7 International Units per Liter | Standard Deviation 23.29 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 288; n=31, 38, 45, 0 | 1.2 International Units per Liter | Standard Deviation 27.16 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 300; n=30, 37, 44, 0 | -1.4 International Units per Liter | Standard Deviation 19.21 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 312; n=31, 34, 43, 0 | 7.6 International Units per Liter | Standard Deviation 42.61 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 324; n=3, 4, 3, 0 | 1.3 International Units per Liter | Standard Deviation 8.73 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 2; n=58, 56, 58, 58 | -1.3 International Units per Liter | Standard Deviation 11.2 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 4; n=58, 57, 59, 57 | -2.8 International Units per Liter | Standard Deviation 8.97 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 8; n=58, 55, 57, 54 | 1.5 International Units per Liter | Standard Deviation 22.15 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 12; n=58, 53, 57, 50 | 1.6 International Units per Liter | Standard Deviation 21.65 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 16; n=57, 54, 57, 52 | 1.9 International Units per Liter | Standard Deviation 23.46 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 20; n=56, 54, 55, 49 | -3.1 International Units per Liter | Standard Deviation 10.44 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 24; n=56, 53, 56, 47 | -0.3 International Units per Liter | Standard Deviation 15.64 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 26; n=48, 50, 53, 45 | -0.9 International Units per Liter | Standard Deviation 16.1 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 28; n=51, 52, 52, 45 | -0.2 International Units per Liter | Standard Deviation 15.51 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 32; n=52, 53, 55, 45 | -1.0 International Units per Liter | Standard Deviation 16.15 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 36; n=52, 52, 55, 45 | -2.1 International Units per Liter | Standard Deviation 12.13 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 40; n=52, 53, 55, 44 | -2.9 International Units per Liter | Standard Deviation 10.87 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 48; n=51, 53, 54, 44 | -3.2 International Units per Liter | Standard Deviation 12.28 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 60; n=48, 47, 53, 44 | -2.0 International Units per Liter | Standard Deviation 13.06 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 72; n=47, 47, 52, 42 | 3.7 International Units per Liter | Standard Deviation 24.41 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 84; n=46, 48, 52, 42 | 2.0 International Units per Liter | Standard Deviation 19.02 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 96; n=45, 48, 52, 40 | 20.5 International Units per Liter | Standard Deviation 150.1 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 108; n=43, 46, 48, 0 | -4.0 International Units per Liter | Standard Deviation 11.71 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 120; n=40, 45, 48, 0 | -2.5 International Units per Liter | Standard Deviation 13.44 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 132; n=40, 46, 49, 0 | -3.9 International Units per Liter | Standard Deviation 12.4 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 144; n=37, 45, 47, 0 | -4.3 International Units per Liter | Standard Deviation 13.76 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 156; n=37, 42, 49, 0 | -3.2 International Units per Liter | Standard Deviation 13.94 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 168; n=35, 43, 47, 0 | -3.4 International Units per Liter | Standard Deviation 12.15 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 180; n=36, 41, 47, 0 | -4.2 International Units per Liter | Standard Deviation 12.71 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 192; n=36, 39, 47, 0 | -5.3 International Units per Liter | Standard Deviation 11 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 204; n=34, 39, 47, 0 | -4.8 International Units per Liter | Standard Deviation 10.98 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 216; n=33, 39, 46, 0 | -4.9 International Units per Liter | Standard Deviation 11.54 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 228; n=32, 39, 47, 0 | -5.9 International Units per Liter | Standard Deviation 11.78 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 240; n=30, 39, 46, 0 | -5.3 International Units per Liter | Standard Deviation 11.7 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 252; n=31, 38, 46, 0 | -2.1 International Units per Liter | Standard Deviation 15.31 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 264; n=32, 38, 47, 0 | -4.3 International Units per Liter | Standard Deviation 15.09 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 276; n=31, 38, 45, 0 | -3.3 International Units per Liter | Standard Deviation 14.38 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 288; n=31, 38, 45, 0 | -3.6 International Units per Liter | Standard Deviation 14.93 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 300; n=30, 37, 44, 0 | -5.3 International Units per Liter | Standard Deviation 13.01 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 312; n=31, 34, 43, 0 | -2.3 International Units per Liter | Standard Deviation 17.39 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 324; n=3, 4, 3, 0 | -5.3 International Units per Liter | Standard Deviation 14.59 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 2; n=58, 56, 58, 58 | -32.2 International Units per Liter | Standard Deviation 664.29 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 4; n=58, 57, 59, 57 | -82.0 International Units per Liter | Standard Deviation 586.36 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 8; n=58, 55, 57, 54 | 115.8 International Units per Liter | Standard Deviation 1625.63 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 12; n=58, 53, 57, 51 | 39.8 International Units per Liter | Standard Deviation 1035.75 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 16; n=57, 54, 57, 52 | 156.3 International Units per Liter | Standard Deviation 1399.82 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 20; n=56, 54, 55, 49 | -68.9 International Units per Liter | Standard Deviation 542.73 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 24; n=56, 53, 56, 47 | 32.4 International Units per Liter | Standard Deviation 800.5 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 26; n=48, 50, 53, 45 | -16.3 International Units per Liter | Standard Deviation 616.41 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 28; n=51, 52, 52, 45 | 74.1 International Units per Liter | Standard Deviation 542.07 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 32; n=52, 53, 55, 45 | -25.1 International Units per Liter | Standard Deviation 605.67 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 36; n=52, 52, 55, 45 | -33.6 International Units per Liter | Standard Deviation 572.93 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 40; n=52, 53, 55, 44 | -48.6 International Units per Liter | Standard Deviation 502.19 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 48; n=51, 53, 54, 44 | -54.7 International Units per Liter | Standard Deviation 612.26 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 60; n=48, 47, 53, 44 | -80.1 International Units per Liter | Standard Deviation 598.41 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 72; n=47, 47, 52, 42 | 53.8 International Units per Liter | Standard Deviation 1031.26 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 84; n=46, 48, 52, 42 | 33.6 International Units per Liter | Standard Deviation 900.48 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 96; n=45, 48, 52, 40 | -22.8 International Units per Liter | Standard Deviation 768.54 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 108; n=43, 46, 48, 0 | -88.5 International Units per Liter | Standard Deviation 592.61 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 120; n=40, 45, 48, 0 | -48.9 International Units per Liter | Standard Deviation 614.32 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 132; n=40, 46, 49, 0 | -41.3 International Units per Liter | Standard Deviation 654.65 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 32; n=52, 53, 55, 45 | -1.7 International Units per Liter | Standard Deviation 25.75 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 156; n=37, 42, 49, 0 | -87.9 International Units per Liter | Standard Deviation 626.53 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 168; n=35, 43, 47, 0 | -60.7 International Units per Liter | Standard Deviation 648.64 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 180; n=36, 41, 47, 0 | -16.4 International Units per Liter | Standard Deviation 769.12 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 192; n=36, 39, 47, 0 | -98.5 International Units per Liter | Standard Deviation 666.21 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 204; n=34, 39, 47, 0 | -101.8 International Units per Liter | Standard Deviation 642.05 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 216; n=33, 39, 46, 0 | -74.4 International Units per Liter | Standard Deviation 658.64 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 228; n=32, 39, 47, 0 | -129.0 International Units per Liter | Standard Deviation 640.89 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 240; n=30, 39, 46, 0 | -108.1 International Units per Liter | Standard Deviation 646.43 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 252; n=31, 38, 46, 0 | -110.1 International Units per Liter | Standard Deviation 645.37 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 264; n=32, 38, 47, 0 | -31.3 International Units per Liter | Standard Deviation 819.97 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 276; n=31, 38, 45, 0 | -126.5 International Units per Liter | Standard Deviation 639.63 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 288; n=31, 38, 45, 0 | -98.5 International Units per Liter | Standard Deviation 642.79 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 300; n=30, 37, 44, 0 | -100.7 International Units per Liter | Standard Deviation 684.43 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 312; n=31, 34, 43, 0 | -141.3 International Units per Liter | Standard Deviation 681.29 |
| GSK1265744 30 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 324; n=3, 4, 3, 0 | -195.0 International Units per Liter | Standard Deviation 417.89 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 20; n=56, 54, 55, 49 | 3.0 International Units per Liter | Standard Deviation 18.56 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 252; n=31, 38, 46, 0 | -1.6 International Units per Liter | Standard Deviation 20.95 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 264; n=32, 38, 47, 0 | 38.9 International Units per Liter | Standard Deviation 137.9 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 204; n=34, 39, 47, 0 | -4.5 International Units per Liter | Standard Deviation 12.04 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 240; n=30, 39, 46, 0 | -0.7 International Units per Liter | Standard Deviation 18.2 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 144; n=37, 45, 47, 0 | 68.7 International Units per Liter | Standard Deviation 192.2 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 216; n=33, 39, 46, 0 | -4.3 International Units per Liter | Standard Deviation 13.42 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 228; n=32, 39, 47, 0 | 0.5 International Units per Liter | Standard Deviation 17.72 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 228; n=32, 39, 47, 0 | 40.4 International Units per Liter | Standard Deviation 133.68 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 40; n=52, 53, 55, 44 | 103.5 International Units per Liter | Standard Deviation 390.1 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 4; n=58, 57, 59, 57 | 1.7 International Units per Liter | Standard Deviation 22.01 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 48; n=51, 53, 54, 44 | 28.6 International Units per Liter | Standard Deviation 196.37 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 32; n=52, 53, 55, 45 | -4.0 International Units per Liter | Standard Deviation 13.9 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 60; n=48, 47, 53, 44 | 206.2 International Units per Liter | Standard Deviation 880.62 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 28; n=51, 52, 52, 45 | -2.9 International Units per Liter | Standard Deviation 17.79 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 240; n=30, 39, 46, 0 | 92.0 International Units per Liter | Standard Deviation 285.12 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 72; n=47, 47, 52, 42 | 67.6 International Units per Liter | Standard Deviation 311.66 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 24; n=56, 53, 56, 47 | 1.5 International Units per Liter | Standard Deviation 15.03 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 26; n=48, 50, 53, 45 | -1.7 International Units per Liter | Standard Deviation 8.21 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 20; n=56, 54, 55, 49 | 4.6 International Units per Liter | Standard Deviation 23.87 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 28; n=51, 52, 52, 45 | -1.9 International Units per Liter | Standard Deviation 13.67 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 84; n=46, 48, 52, 42 | 14.9 International Units per Liter | Standard Deviation 211.36 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 32; n=52, 53, 55, 45 | -1.4 International Units per Liter | Standard Deviation 9.19 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 16; n=57, 54, 57, 52 | -0.6 International Units per Liter | Standard Deviation 8.03 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 36; n=52, 52, 55, 45 | -0.6 International Units per Liter | Standard Deviation 11.86 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 26; n=48, 50, 53, 45 | -1.7 International Units per Liter | Standard Deviation 13.07 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 40; n=52, 53, 55, 44 | -0.5 International Units per Liter | Standard Deviation 14.4 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 12; n=58, 53, 57, 50 | -1.7 International Units per Liter | Standard Deviation 8.91 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 300; n=30, 37, 44, 0 | 56.0 International Units per Liter | Standard Deviation 195.62 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 48; n=51, 53, 54, 44 | -3.0 International Units per Liter | Standard Deviation 8.28 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 96; n=45, 48, 52, 40 | 19.6 International Units per Liter | Standard Deviation 249.41 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 60; n=48, 47, 53, 44 | 3.0 International Units per Liter | Standard Deviation 18.7 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 8; n=58, 55, 57, 54 | 5.3 International Units per Liter | Standard Deviation 36.86 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 72; n=47, 47, 52, 42 | -0.5 International Units per Liter | Standard Deviation 9.75 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 84; n=46, 48, 52, 42 | -1.8 International Units per Liter | Standard Deviation 9.46 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 4; n=58, 57, 59, 57 | 0.1 International Units per Liter | Standard Deviation 14.56 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 252; n=31, 38, 46, 0 | 62.5 International Units per Liter | Standard Deviation 201.59 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 96; n=45, 48, 52, 40 | -1.0 International Units per Liter | Standard Deviation 12.58 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 108; n=43, 46, 48, 0 | 100.3 International Units per Liter | Standard Deviation 546.46 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 108; n=43, 46, 48, 0 | 0.6 International Units per Liter | Standard Deviation 22.77 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 2; n=58, 56, 58, 58 | -1.6 International Units per Liter | Standard Deviation 8.85 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 24; n=56, 53, 56, 47 | 1.4 International Units per Liter | Standard Deviation 19.49 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 120; n=40, 45, 48, 0 | -2.4 International Units per Liter | Standard Deviation 10.9 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 324; n=3, 4, 3, 0 | 1.0 International Units per Liter | Standard Deviation 4.36 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 2; n=58, 56, 58, 58 | -1.5 International Units per Liter | Standard Deviation 14.75 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 132; n=40, 46, 49, 0 | 0.7 International Units per Liter | Standard Deviation 32.61 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 312; n=31, 34, 43, 0 | 0.0 International Units per Liter | Standard Deviation 22.51 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 120; n=40, 45, 48, 0 | 61.4 International Units per Liter | Standard Deviation 304.98 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 144; n=37, 45, 47, 0 | -3.9 International Units per Liter | Standard Deviation 9.45 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 300; n=30, 37, 44, 0 | -1.8 International Units per Liter | Standard Deviation 24.06 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 156; n=37, 42, 49, 0 | -4.1 International Units per Liter | Standard Deviation 13.08 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 288; n=31, 38, 45, 0 | 1.9 International Units per Liter | Standard Deviation 26.19 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 48; n=51, 53, 54, 44 | -2.4 International Units per Liter | Standard Deviation 14.6 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 168; n=35, 43, 47, 0 | -3.8 International Units per Liter | Standard Deviation 13.44 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 276; n=31, 38, 45, 0 | 1.1 International Units per Liter | Standard Deviation 23.92 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 132; n=40, 46, 49, 0 | 649.6 International Units per Liter | Standard Deviation 3895.73 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 180; n=36, 41, 47, 0 | -2.9 International Units per Liter | Standard Deviation 17.09 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 264; n=32, 38, 47, 0 | 2.0 International Units per Liter | Standard Deviation 29.6 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 192; n=36, 39, 47, 0 | 0.1 International Units per Liter | Standard Deviation 20.52 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 228; n=32, 39, 47, 0 | -2.8 International Units per Liter | Standard Deviation 10.14 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 216; n=33, 39, 46, 0 | -2.7 International Units per Liter | Standard Deviation 26.9 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 132; n=40, 46, 49, 0 | -3.8 International Units per Liter | Standard Deviation 17.8 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 240; n=30, 39, 46, 0 | -3.4 International Units per Liter | Standard Deviation 11.32 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 204; n=34, 39, 47, 0 | -3.4 International Units per Liter | Standard Deviation 24 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 156; n=37, 42, 49, 0 | 73.3 International Units per Liter | Standard Deviation 396.95 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 252; n=31, 38, 46, 0 | -3.9 International Units per Liter | Standard Deviation 11.09 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 192; n=36, 39, 47, 0 | 1.3 International Units per Liter | Standard Deviation 35.53 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 16; n=57, 54, 57, 52 | -0.3 International Units per Liter | Standard Deviation 13.36 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 264; n=32, 38, 47, 0 | -2.9 International Units per Liter | Standard Deviation 12.87 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 180; n=36, 41, 47, 0 | -1.2 International Units per Liter | Standard Deviation 31.69 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 324; n=3, 4, 3, 0 | 102.7 International Units per Liter | Standard Deviation 157.82 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 276; n=31, 38, 45, 0 | -1.4 International Units per Liter | Standard Deviation 12.8 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 168; n=35, 43, 47, 0 | -3.6 International Units per Liter | Standard Deviation 24.29 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 168; n=35, 43, 47, 0 | 74.4 International Units per Liter | Standard Deviation 492.75 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 288; n=31, 38, 45, 0 | -2.2 International Units per Liter | Standard Deviation 12.98 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 156; n=37, 42, 49, 0 | -2.2 International Units per Liter | Standard Deviation 27.94 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 300; n=30, 37, 44, 0 | -4.1 International Units per Liter | Standard Deviation 12.07 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 144; n=37, 45, 47, 0 | -1.8 International Units per Liter | Standard Deviation 15.4 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 276; n=31, 38, 45, 0 | 146.4 International Units per Liter | Standard Deviation 350.73 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 312; n=31, 34, 43, 0 | -0.3 International Units per Liter | Standard Deviation 14.27 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 120; n=40, 45, 48, 0 | -3.7 International Units per Liter | Standard Deviation 15.82 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 180; n=36, 41, 47, 0 | 62.8 International Units per Liter | Standard Deviation 325.34 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 324; n=3, 4, 3, 0 | -6.7 International Units per Liter | Standard Deviation 4.16 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 108; n=43, 46, 48, 0 | -0.7 International Units per Liter | Standard Deviation 20.63 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 12; n=58, 53, 57, 51 | -0.6 International Units per Liter | Standard Deviation 13.4 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 2; n=58, 56, 58, 58 | 0.4 International Units per Liter | Standard Deviation 183.47 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 72; n=47, 47, 52, 42 | -0.9 International Units per Liter | Standard Deviation 15.27 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 4; n=58, 57, 59, 57 | -2.9 International Units per Liter | Standard Deviation 227.73 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 96; n=45, 48, 52, 40 | -1.7 International Units per Liter | Standard Deviation 17.12 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 192; n=36, 39, 47, 0 | 98.6 International Units per Liter | Standard Deviation 393.41 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 8; n=58, 55, 57, 54 | 266.7 International Units per Liter | Standard Deviation 1787.23 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 12; n=58, 53, 57, 51 | 27.1 International Units per Liter | Standard Deviation 208.15 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 84; n=46, 48, 52, 42 | -2.0 International Units per Liter | Standard Deviation 16.9 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 312; n=31, 34, 43, 0 | 209.4 International Units per Liter | Standard Deviation 862.1 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 16; n=57, 54, 57, 52 | 28.6 International Units per Liter | Standard Deviation 218.04 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 204; n=34, 39, 47, 0 | 48.3 International Units per Liter | Standard Deviation 148.37 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 20; n=56, 54, 55, 49 | 298.9 International Units per Liter | Standard Deviation 1661.14 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 8; n=58, 55, 57, 54 | 8.0 International Units per Liter | Standard Deviation 56.59 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 24; n=56, 53, 56, 47 | 55.9 International Units per Liter | Standard Deviation 252.05 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 60; n=48, 47, 53, 44 | 0.5 International Units per Liter | Standard Deviation 18.13 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 288; n=31, 38, 45, 0 | 43.4 International Units per Liter | Standard Deviation 172.08 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 26; n=48, 50, 53, 45 | 54.4 International Units per Liter | Standard Deviation 316.26 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 216; n=33, 39, 46, 0 | 41.9 International Units per Liter | Standard Deviation 177.16 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 28; n=51, 52, 52, 45 | 96.8 International Units per Liter | Standard Deviation 475.89 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 40; n=52, 53, 55, 44 | -1.4 International Units per Liter | Standard Deviation 15.96 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 32; n=52, 53, 55, 45 | 122.1 International Units per Liter | Standard Deviation 364.15 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 36; n=52, 52, 55, 45 | 66.1 International Units per Liter | Standard Deviation 276.38 |
| GSK1265744 60 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 36; n=52, 52, 55, 45 | -3.0 International Units per Liter | Standard Deviation 15.31 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 16; n=57, 54, 57, 52 | -1.6 International Units per Liter | Standard Deviation 38.9 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 26; n=48, 50, 53, 45 | -3.7 International Units per Liter | Standard Deviation 41.02 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 24; n=56, 53, 56, 47 | -6.0 International Units per Liter | Standard Deviation 33.13 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 24; n=56, 53, 56, 47 | 103.9 International Units per Liter | Standard Deviation 482.18 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 26; n=48, 50, 53, 45 | -2.6 International Units per Liter | Standard Deviation 17.81 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 48; n=51, 53, 54, 44 | -4.4 International Units per Liter | Standard Deviation 16.67 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 2; n=58, 56, 58, 58 | -1.3 International Units per Liter | Standard Deviation 23.63 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 26; n=48, 50, 53, 45 | 21.2 International Units per Liter | Standard Deviation 162.22 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 40; n=52, 53, 55, 44 | -8.0 International Units per Liter | Standard Deviation 32.36 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 8; n=58, 55, 57, 54 | -7.3 International Units per Liter | Standard Deviation 29.65 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 28; n=51, 52, 52, 45 | -5.1 International Units per Liter | Standard Deviation 15.42 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 28; n=51, 52, 52, 45 | 4.1 International Units per Liter | Standard Deviation 159.24 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 16; n=57, 54, 57, 52 | 4.4 International Units per Liter | Standard Deviation 79.53 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 4; n=58, 57, 59, 57 | 0.1 International Units per Liter | Standard Deviation 29.43 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 20; n=56, 54, 55, 49 | -4.8 International Units per Liter | Standard Deviation 34.09 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 32; n=52, 53, 55, 45 | 110.3 International Units per Liter | Standard Deviation 794.67 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 36; n=52, 52, 55, 45 | -8.2 International Units per Liter | Standard Deviation 32.34 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 48; n=51, 53, 54, 44 | -8.6 International Units per Liter | Standard Deviation 34.8 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 12; n=58, 53, 57, 51 | -6.3 International Units per Liter | Standard Deviation 33.57 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 84; n=46, 48, 52, 42 | 2.3 International Units per Liter | Standard Deviation 40.93 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 36; n=52, 52, 55, 45 | 158.7 International Units per Liter | Standard Deviation 625.32 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 32; n=52, 53, 55, 45 | -2.8 International Units per Liter | Standard Deviation 17.86 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 60; n=48, 47, 53, 44 | -3.2 International Units per Liter | Standard Deviation 17.49 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 84; n=46, 48, 52, 42 | 123.9 International Units per Liter | Standard Deviation 598.22 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 40; n=52, 53, 55, 44 | 3.8 International Units per Liter | Standard Deviation 128.31 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 32; n=52, 53, 55, 45 | -8.6 International Units per Liter | Standard Deviation 34.85 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 96; n=45, 48, 52, 40 | -0.3 International Units per Liter | Standard Deviation 25.99 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 36; n=52, 52, 55, 45 | -1.9 International Units per Liter | Standard Deviation 17.93 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 48; n=51, 53, 54, 44 | 2.8 International Units per Liter | Standard Deviation 124.04 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 2; n=58, 56, 58, 58 | 159.8 International Units per Liter | Standard Deviation 3217.64 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 96; n=45, 48, 52, 40 | -7.6 International Units per Liter | Standard Deviation 20.22 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 28; n=51, 52, 52, 45 | -8.1 International Units per Liter | Standard Deviation 33.92 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 12; n=58, 53, 57, 50 | -7.9 International Units per Liter | Standard Deviation 32.18 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 4; n=58, 57, 59, 57 | -120.3 International Units per Liter | Standard Deviation 1656.37 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 96; n=45, 48, 52, 40 | 143.9 International Units per Liter | Standard Deviation 903.29 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 60; n=48, 47, 53, 44 | 24.5 International Units per Liter | Standard Deviation 158.37 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 2; n=58, 56, 58, 58 | 0.9 International Units per Liter | Standard Deviation 58.63 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 8; n=58, 55, 57, 54 | -212.8 International Units per Liter | Standard Deviation 1579.19 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 84; n=46, 48, 52, 42 | -4.0 International Units per Liter | Standard Deviation 49.06 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 8; n=58, 55, 57, 54 | -6.3 International Units per Liter | Standard Deviation 29.64 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 40; n=52, 53, 55, 44 | -5.1 International Units per Liter | Standard Deviation 14.94 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 12; n=58, 53, 57, 51 | -220.1 International Units per Liter | Standard Deviation 1656.33 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 72; n=47, 47, 52, 42 | -4.6 International Units per Liter | Standard Deviation 15.69 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 72; n=47, 47, 52, 42 | -14.3 International Units per Liter | Standard Deviation 92.49 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 4; n=58, 57, 59, 57 | -2.9 International Units per Liter | Standard Deviation 31.52 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 16; n=57, 54, 57, 52 | 269.7 International Units per Liter | Standard Deviation 3855.01 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 72; n=47, 47, 52, 42 | -8.5 International Units per Liter | Standard Deviation 36.32 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 24; n=56, 53, 56, 47 | -2.1 International Units per Liter | Standard Deviation 13.59 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | AST; Week 20; n=56, 54, 55, 49 | -3.6 International Units per Liter | Standard Deviation 41.56 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | CK; Week 20; n=56, 54, 55, 49 | 135.3 International Units per Liter | Standard Deviation 3115.23 |
| Efavirenz 600 mg | Change From Baseline in ALT, AST and CK Over Time by Visit | ALT; Week 60; n=48, 47, 53, 44 | -6.3 International Units per Liter | Standard Deviation 36.82 |
Secondary
Change From Baseline in CD4+ Cell Count Over Time by Visit
CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
Time frame: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Population: ITT-E Population.Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 180; n=36, 41, 47, 0 | 338.0 Cells per cubic millimeter | Standard Deviation 218.72 |
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 132; n=40, 46, 49, 0 | 297.1 Cells per cubic millimeter | Standard Deviation 167.59 |
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 264; n=32, 38, 47, 0 | 344.4 Cells per cubic millimeter | Standard Deviation 160.38 |
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 8; n=58, 56, 57, 55 | 129.9 Cells per cubic millimeter | Standard Deviation 123.47 |
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 28; n=49, 52, 52, 45 | 205.0 Cells per cubic millimeter | Standard Deviation 164.91 |
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 192; n=35, 40, 47, 0 | 300.8 Cells per cubic millimeter | Standard Deviation 168.24 |
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 120; n=41, 46, 49, 0 | 266.1 Cells per cubic millimeter | Standard Deviation 173.09 |
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 288; n=30, 38, 45, 0 | 411.0 Cells per cubic millimeter | Standard Deviation 161.93 |
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 32; n=52, 53, 55, 45 | 191.4 Cells per cubic millimeter | Standard Deviation 151.79 |
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 144; n=37, 45, 46, 0 | 330.7 Cells per cubic millimeter | Standard Deviation 225.42 |
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 2; n=57, 56, 59, 59 | 92.6 Cells per cubic millimeter | Standard Deviation 112.44 |
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 204; n=34, 39, 47, 0 | 369.5 Cells per cubic millimeter | Standard Deviation 196.17 |
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 36; n=52, 53, 55, 45 | 192.0 Cells per cubic millimeter | Standard Deviation 165.97 |
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 16; n=57, 54, 57, 52 | 159.3 Cells per cubic millimeter | Standard Deviation 115.36 |
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 312; n=30, 34, 43, 0 | 335.0 Cells per cubic millimeter | Standard Deviation 176.73 |
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 276; n=31, 38, 46, 0 | 398.3 Cells per cubic millimeter | Standard Deviation 250.45 |
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 40; n=52, 53, 55, 45 | 203.6 Cells per cubic millimeter | Standard Deviation 171.74 |
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 156; n=37, 42, 49, 0 | 334.5 Cells per cubic millimeter | Standard Deviation 213.79 |
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 26; n=48, 50, 53, 45 | 186.4 Cells per cubic millimeter | Standard Deviation 153.99 |
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 216; n=33, 39, 47, 0 | 397.0 Cells per cubic millimeter | Standard Deviation 202.03 |
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 48; n=51, 53, 54, 44 | 235.1 Cells per cubic millimeter | Standard Deviation 179.89 |
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 324; n=3, 4, 3, 0 | 402.0 Cells per cubic millimeter | Standard Deviation 197.55 |
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 20; n=56, 54, 56, 49 | 165.2 Cells per cubic millimeter | Standard Deviation 146.9 |
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 252; n=31, 38, 47, 0 | 400.3 Cells per cubic millimeter | Standard Deviation 183.36 |
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 60; n=48, 47, 53, 44 | 217.7 Cells per cubic millimeter | Standard Deviation 152.92 |
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 168; n=35, 43, 47, 0 | 338.1 Cells per cubic millimeter | Standard Deviation 252.13 |
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 4; n=58, 57, 59, 57 | 136.4 Cells per cubic millimeter | Standard Deviation 157.36 |
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 228; n=32, 39, 47, 0 | 331.8 Cells per cubic millimeter | Standard Deviation 168.64 |
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 72; n=47, 48, 52, 42 | 232.0 Cells per cubic millimeter | Standard Deviation 191.05 |
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 300; n=30, 37, 44, 0 | 437.7 Cells per cubic millimeter | Standard Deviation 196.33 |
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 24; n=56, 53, 56, 47 | 172.5 Cells per cubic millimeter | Standard Deviation 112.04 |
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 240; n=32, 39, 47, 0 | 356.5 Cells per cubic millimeter | Standard Deviation 195.99 |
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 84; n=46, 48, 52, 42 | 261.5 Cells per cubic millimeter | Standard Deviation 171.65 |
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 12; n=58, 53, 57, 51 | 140.5 Cells per cubic millimeter | Standard Deviation 142.86 |
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 108; n=43, 46, 49, 0 | 296.2 Cells per cubic millimeter | Standard Deviation 215.21 |
| GSK1265744 10 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 96; n=46, 46, 52, 41 | 269.4 Cells per cubic millimeter | Standard Deviation 204.32 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 216; n=33, 39, 47, 0 | 373.4 Cells per cubic millimeter | Standard Deviation 188.28 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 96; n=46, 46, 52, 41 | 267.5 Cells per cubic millimeter | Standard Deviation 196.27 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 108; n=43, 46, 49, 0 | 304.3 Cells per cubic millimeter | Standard Deviation 195.3 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 120; n=41, 46, 49, 0 | 279.3 Cells per cubic millimeter | Standard Deviation 181.1 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 8; n=58, 56, 57, 55 | 117.8 Cells per cubic millimeter | Standard Deviation 132.19 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 132; n=40, 46, 49, 0 | 305.2 Cells per cubic millimeter | Standard Deviation 184.98 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 144; n=37, 45, 46, 0 | 308.9 Cells per cubic millimeter | Standard Deviation 224.63 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 156; n=37, 42, 49, 0 | 319.2 Cells per cubic millimeter | Standard Deviation 182.15 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 312; n=30, 34, 43, 0 | 433.0 Cells per cubic millimeter | Standard Deviation 264.63 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 180; n=36, 41, 47, 0 | 348.6 Cells per cubic millimeter | Standard Deviation 203.73 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 12; n=58, 53, 57, 51 | 140.8 Cells per cubic millimeter | Standard Deviation 165.02 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 192; n=35, 40, 47, 0 | 351.0 Cells per cubic millimeter | Standard Deviation 205.56 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 204; n=34, 39, 47, 0 | 332.9 Cells per cubic millimeter | Standard Deviation 179.28 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 16; n=57, 54, 57, 52 | 142.2 Cells per cubic millimeter | Standard Deviation 145.64 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 168; n=35, 43, 47, 0 | 332.4 Cells per cubic millimeter | Standard Deviation 222.37 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 300; n=30, 37, 44, 0 | 404.4 Cells per cubic millimeter | Standard Deviation 239.11 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 20; n=56, 54, 56, 49 | 153.8 Cells per cubic millimeter | Standard Deviation 150.4 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 24; n=56, 53, 56, 47 | 180.9 Cells per cubic millimeter | Standard Deviation 161.43 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 228; n=32, 39, 47, 0 | 366.5 Cells per cubic millimeter | Standard Deviation 231.25 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 26; n=48, 50, 53, 45 | 177.7 Cells per cubic millimeter | Standard Deviation 146.84 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 288; n=30, 38, 45, 0 | 383.5 Cells per cubic millimeter | Standard Deviation 279.75 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 28; n=49, 52, 52, 45 | 188.1 Cells per cubic millimeter | Standard Deviation 132.08 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 264; n=32, 38, 47, 0 | 365.0 Cells per cubic millimeter | Standard Deviation 210 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 32; n=52, 53, 55, 45 | 205.2 Cells per cubic millimeter | Standard Deviation 145.53 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 276; n=31, 38, 46, 0 | 350.3 Cells per cubic millimeter | Standard Deviation 210.98 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 36; n=52, 53, 55, 45 | 213.0 Cells per cubic millimeter | Standard Deviation 144.89 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 2; n=57, 56, 59, 59 | 79.5 Cells per cubic millimeter | Standard Deviation 118.15 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 40; n=52, 53, 55, 45 | 212.8 Cells per cubic millimeter | Standard Deviation 180.38 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 252; n=31, 38, 47, 0 | 343.7 Cells per cubic millimeter | Standard Deviation 196.09 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 48; n=51, 53, 54, 44 | 241.6 Cells per cubic millimeter | Standard Deviation 182.9 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 324; n=3, 4, 3, 0 | 276.0 Cells per cubic millimeter | Standard Deviation 278.28 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 60; n=48, 47, 53, 44 | 269.4 Cells per cubic millimeter | Standard Deviation 188.34 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 240; n=32, 39, 47, 0 | 395.9 Cells per cubic millimeter | Standard Deviation 205.55 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 72; n=47, 48, 52, 42 | 201.4 Cells per cubic millimeter | Standard Deviation 206.54 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 4; n=58, 57, 59, 57 | 76.9 Cells per cubic millimeter | Standard Deviation 107.01 |
| GSK1265744 30 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 84; n=46, 48, 52, 42 | 287.0 Cells per cubic millimeter | Standard Deviation 207.1 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 324; n=3, 4, 3, 0 | 272.0 Cells per cubic millimeter | Standard Deviation 277.44 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 132; n=40, 46, 49, 0 | 313.2 Cells per cubic millimeter | Standard Deviation 168.3 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 2; n=57, 56, 59, 59 | 91.7 Cells per cubic millimeter | Standard Deviation 127.92 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 4; n=58, 57, 59, 57 | 88.2 Cells per cubic millimeter | Standard Deviation 110.01 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 8; n=58, 56, 57, 55 | 90.5 Cells per cubic millimeter | Standard Deviation 148.25 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 12; n=58, 53, 57, 51 | 145.2 Cells per cubic millimeter | Standard Deviation 142.24 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 16; n=57, 54, 57, 52 | 148.3 Cells per cubic millimeter | Standard Deviation 131.81 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 20; n=56, 54, 56, 49 | 182.6 Cells per cubic millimeter | Standard Deviation 142.18 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 24; n=56, 53, 56, 47 | 204.0 Cells per cubic millimeter | Standard Deviation 166.78 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 26; n=48, 50, 53, 45 | 194.7 Cells per cubic millimeter | Standard Deviation 149.66 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 28; n=49, 52, 52, 45 | 193.3 Cells per cubic millimeter | Standard Deviation 154.43 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 32; n=52, 53, 55, 45 | 209.9 Cells per cubic millimeter | Standard Deviation 157.56 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 36; n=52, 53, 55, 45 | 265.0 Cells per cubic millimeter | Standard Deviation 169.42 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 40; n=52, 53, 55, 45 | 212.3 Cells per cubic millimeter | Standard Deviation 114.67 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 48; n=51, 53, 54, 44 | 259.0 Cells per cubic millimeter | Standard Deviation 154.21 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 60; n=48, 47, 53, 44 | 266.1 Cells per cubic millimeter | Standard Deviation 156.03 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 72; n=47, 48, 52, 42 | 254.0 Cells per cubic millimeter | Standard Deviation 189.26 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 84; n=46, 48, 52, 42 | 278.1 Cells per cubic millimeter | Standard Deviation 166.11 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 96; n=46, 46, 52, 41 | 286.2 Cells per cubic millimeter | Standard Deviation 181.5 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 108; n=43, 46, 49, 0 | 288.4 Cells per cubic millimeter | Standard Deviation 184.61 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 120; n=41, 46, 49, 0 | 307.2 Cells per cubic millimeter | Standard Deviation 225.39 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 144; n=37, 45, 46, 0 | 322.4 Cells per cubic millimeter | Standard Deviation 224.57 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 156; n=37, 42, 49, 0 | 320.4 Cells per cubic millimeter | Standard Deviation 187.58 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 168; n=35, 43, 47, 0 | 361.3 Cells per cubic millimeter | Standard Deviation 198.98 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 180; n=36, 41, 47, 0 | 384.2 Cells per cubic millimeter | Standard Deviation 192.86 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 192; n=35, 40, 47, 0 | 342.3 Cells per cubic millimeter | Standard Deviation 204.83 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 204; n=34, 39, 47, 0 | 340.0 Cells per cubic millimeter | Standard Deviation 191.82 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 216; n=33, 39, 47, 0 | 357.8 Cells per cubic millimeter | Standard Deviation 199.87 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 228; n=32, 39, 47, 0 | 383.7 Cells per cubic millimeter | Standard Deviation 253.17 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 240; n=32, 39, 47, 0 | 408.4 Cells per cubic millimeter | Standard Deviation 201.05 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 252; n=31, 38, 47, 0 | 383.1 Cells per cubic millimeter | Standard Deviation 217.2 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 264; n=32, 38, 47, 0 | 391.8 Cells per cubic millimeter | Standard Deviation 222 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 276; n=31, 38, 46, 0 | 362.2 Cells per cubic millimeter | Standard Deviation 243.3 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 288; n=30, 38, 45, 0 | 337.1 Cells per cubic millimeter | Standard Deviation 187.13 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 300; n=30, 37, 44, 0 | 353.5 Cells per cubic millimeter | Standard Deviation 200.23 |
| GSK1265744 60 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 312; n=30, 34, 43, 0 | 407.0 Cells per cubic millimeter | Standard Deviation 178.06 |
| Efavirenz 600 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 12; n=58, 53, 57, 51 | 103.4 Cells per cubic millimeter | Standard Deviation 125.39 |
| Efavirenz 600 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 8; n=58, 56, 57, 55 | 65.6 Cells per cubic millimeter | Standard Deviation 120.25 |
| Efavirenz 600 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 36; n=52, 53, 55, 45 | 185.2 Cells per cubic millimeter | Standard Deviation 152.91 |
| Efavirenz 600 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 32; n=52, 53, 55, 45 | 197.4 Cells per cubic millimeter | Standard Deviation 170.48 |
| Efavirenz 600 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 24; n=56, 53, 56, 47 | 143.4 Cells per cubic millimeter | Standard Deviation 145.18 |
| Efavirenz 600 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 28; n=49, 52, 52, 45 | 178.2 Cells per cubic millimeter | Standard Deviation 150.25 |
| Efavirenz 600 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 26; n=48, 50, 53, 45 | 166.4 Cells per cubic millimeter | Standard Deviation 145.11 |
| Efavirenz 600 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 4; n=58, 57, 59, 57 | 46.0 Cells per cubic millimeter | Standard Deviation 106.35 |
| Efavirenz 600 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 96; n=46, 46, 52, 41 | 281.7 Cells per cubic millimeter | Standard Deviation 232.9 |
| Efavirenz 600 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 84; n=46, 48, 52, 42 | 279.4 Cells per cubic millimeter | Standard Deviation 191.3 |
| Efavirenz 600 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 20; n=56, 54, 56, 49 | 149.0 Cells per cubic millimeter | Standard Deviation 117.44 |
| Efavirenz 600 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 16; n=57, 54, 57, 52 | 135.5 Cells per cubic millimeter | Standard Deviation 153.48 |
| Efavirenz 600 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 72; n=47, 48, 52, 42 | 257.1 Cells per cubic millimeter | Standard Deviation 216.41 |
| Efavirenz 600 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 60; n=48, 47, 53, 44 | 263.8 Cells per cubic millimeter | Standard Deviation 181.15 |
| Efavirenz 600 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 2; n=57, 56, 59, 59 | 24.8 Cells per cubic millimeter | Standard Deviation 138.47 |
| Efavirenz 600 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 48; n=51, 53, 54, 44 | 262.5 Cells per cubic millimeter | Standard Deviation 201.33 |
| Efavirenz 600 mg | Change From Baseline in CD4+ Cell Count Over Time by Visit | Week 40; n=52, 53, 55, 45 | 221.5 Cells per cubic millimeter | Standard Deviation 188.99 |
Secondary
Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit
Blood samples were collected for the analysis of creatinine and total bilirubin. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
Time frame: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Population: Safety Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 12; n=58, 53, 57, 51 | 3.39 Micromoles per liter | Standard Deviation 8.591 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 4; n=58, 57, 59, 57 | 2.24 Micromoles per liter | Standard Deviation 6.889 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 132; n=40, 46, 49, 0 | 3.76 Micromoles per liter | Standard Deviation 8.272 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 156; n=37, 42, 49, 0 | 1.6 Micromoles per liter | Standard Deviation 5.07 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 312; n=31, 34, 43, 0 | 1.4 Micromoles per liter | Standard Deviation 5.3 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 144; n=37, 45, 47, 0 | 5.99 Micromoles per liter | Standard Deviation 11.083 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 72; n=47, 47, 52, 42 | 1.5 Micromoles per liter | Standard Deviation 6.05 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 20; n=56, 54, 55, 49 | 2.54 Micromoles per liter | Standard Deviation 6.384 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 156; n=37, 42, 49, 0 | 5.28 Micromoles per liter | Standard Deviation 8.225 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 26; n=48, 50, 53, 45 | 1.1 Micromoles per liter | Standard Deviation 4.97 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 264; n=32, 38, 47, 0 | 0.4 Micromoles per liter | Standard Deviation 5.76 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 168; n=35, 43, 47, 0 | 6.57 Micromoles per liter | Standard Deviation 8.702 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 324; n=3, 4, 3, 0 | 5.3 Micromoles per liter | Standard Deviation 4.16 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 84; n=46, 48, 52, 42 | 2.3 Micromoles per liter | Standard Deviation 5.09 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 180; n=36, 41, 47, 0 | 5.89 Micromoles per liter | Standard Deviation 6.964 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 180; n=36, 41, 47, 0 | 1.1 Micromoles per liter | Standard Deviation 5.54 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 60; n=48, 47, 53, 44 | 3.28 Micromoles per liter | Standard Deviation 7.507 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 192; n=36, 39, 47, 0 | 6.90 Micromoles per liter | Standard Deviation 9.792 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 144; n=37, 45, 47, 0 | 0.7 Micromoles per liter | Standard Deviation 4.7 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 24; n=56, 53, 56, 47 | 2.52 Micromoles per liter | Standard Deviation 7.225 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 204; n=34, 39, 47, 0 | 6.21 Micromoles per liter | Standard Deviation 9.019 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 96; n=45, 48, 52, 40 | 1.0 Micromoles per liter | Standard Deviation 4.15 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 36; n=52, 52, 55, 45 | 1.2 Micromoles per liter | Standard Deviation 4.94 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 216; n=33, 39, 46, 0 | 8.34 Micromoles per liter | Standard Deviation 7.736 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 24; n=56, 53, 56, 47 | 0.5 Micromoles per liter | Standard Deviation 4.26 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 276; n=31, 38, 45, 0 | 0.7 Micromoles per liter | Standard Deviation 3.52 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 228; n=32, 39, 47, 0 | 7.16 Micromoles per liter | Standard Deviation 10.365 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 108; n=43, 46, 48, 0 | 0.7 Micromoles per liter | Standard Deviation 4.86 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 300; n=30, 37, 44, 0 | 1.1 Micromoles per liter | Standard Deviation 4.22 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 240; n=30, 39, 46, 0 | 8.48 Micromoles per liter | Standard Deviation 10.016 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 192; n=36, 39, 47, 0 | 0.7 Micromoles per liter | Standard Deviation 5.88 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 26; n=48, 50, 53, 45 | 2.74 Micromoles per liter | Standard Deviation 7.75 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 252; n=31, 38, 46, 0 | 6.96 Micromoles per liter | Standard Deviation 8.206 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 40; n=52, 53, 55, 44 | 1.6 Micromoles per liter | Standard Deviation 5.03 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 120; n=40, 45, 48, 0 | 0.9 Micromoles per liter | Standard Deviation 4.96 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 264; n=32, 38, 47, 0 | 5.97 Micromoles per liter | Standard Deviation 7.51 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 28; n=51, 52, 52, 45 | 1.1 Micromoles per liter | Standard Deviation 4.39 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 48; n=51, 53, 54, 44 | 2.75 Micromoles per liter | Standard Deviation 9.061 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 276; n=31, 38, 45, 0 | 7.89 Micromoles per liter | Standard Deviation 8.309 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 132; n=40, 46, 49, 0 | 1.0 Micromoles per liter | Standard Deviation 6.16 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 72; n=47, 47, 52, 42 | 3.89 Micromoles per liter | Standard Deviation 7.917 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 288; n=31, 38, 45, 0 | 8.81 Micromoles per liter | Standard Deviation 8.348 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 168; n=35, 43, 47, 0 | 1.1 Micromoles per liter | Standard Deviation 5.37 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 28; n=51, 52, 52, 45 | 2.22 Micromoles per liter | Standard Deviation 6.606 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 300; n=30, 37, 44, 0 | 10.49 Micromoles per liter | Standard Deviation 8.321 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 40; n=52, 53, 55, 44 | 2.83 Micromoles per liter | Standard Deviation 7.966 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 252; n=31, 38, 46, 0 | 1.4 Micromoles per liter | Standard Deviation 5.71 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 312; n=31, 34, 43, 0 | 7.98 Micromoles per liter | Standard Deviation 8.645 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 84; n=46, 48, 52, 42 | 4.58 Micromoles per liter | Standard Deviation 9.834 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 8; n=58, 55, 57, 54 | 2.38 Micromoles per liter | Standard Deviation 8.371 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 324; n=3, 4, 3, 0 | 15.90 Micromoles per liter | Standard Deviation 6.636 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 48; n=51, 53, 54, 44 | 0.9 Micromoles per liter | Standard Deviation 4.58 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 288; n=31, 38, 45, 0 | 0.5 Micromoles per liter | Standard Deviation 5.06 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 2; n=58, 56, 58, 58 | 0.0 Micromoles per liter | Standard Deviation 3.2 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 20; n=56, 54, 55, 49 | -0.1 Micromoles per liter | Standard Deviation 3.96 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 32; n=52, 53, 55, 45 | 3.36 Micromoles per liter | Standard Deviation 8.462 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 2; n=58, 56, 58, 58 | 3.36 Micromoles per liter | Standard Deviation 7.519 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 4; n=58, 57, 59, 57 | 0.1 Micromoles per liter | Standard Deviation 3.39 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 96; n=45, 48, 52, 40 | 1.90 Micromoles per liter | Standard Deviation 11.248 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 204; n=34, 39, 47, 0 | 1.1 Micromoles per liter | Standard Deviation 5.31 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 228; n=32, 39, 47, 0 | 1.6 Micromoles per liter | Standard Deviation 4.61 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 8; n=58, 55, 57, 54 | 0.0 Micromoles per liter | Standard Deviation 3.99 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 16; n=57, 54, 57, 52 | 2.91 Micromoles per liter | Standard Deviation 11.874 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 240; n=30, 39, 46, 0 | 1.2 Micromoles per liter | Standard Deviation 4.92 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 108; n=43, 46, 48, 0 | 5.87 Micromoles per liter | Standard Deviation 9.133 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 12; n=58, 53, 57, 51 | 0.4 Micromoles per liter | Standard Deviation 5.43 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 60; n=48, 47, 53, 44 | 1.9 Micromoles per liter | Standard Deviation 4.31 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 32; n=52, 53, 55, 45 | 0.7 Micromoles per liter | Standard Deviation 3.79 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 216; n=33, 39, 46, 0 | 0.5 Micromoles per liter | Standard Deviation 5.08 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 16; n=57, 54, 57, 52 | 0.4 Micromoles per liter | Standard Deviation 3.96 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 120; n=40, 45, 48, 0 | 4.41 Micromoles per liter | Standard Deviation 8.648 |
| GSK1265744 10 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 36; n=52, 52, 55, 45 | 3.11 Micromoles per liter | Standard Deviation 6.652 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 192; n=36, 39, 47, 0 | 7.91 Micromoles per liter | Standard Deviation 9.528 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 20; n=56, 54, 55, 49 | -0.7 Micromoles per liter | Standard Deviation 3.63 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 36; n=52, 52, 55, 45 | 3.41 Micromoles per liter | Standard Deviation 8.115 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 24; n=56, 53, 56, 47 | 0.2 Micromoles per liter | Standard Deviation 4.45 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 192; n=36, 39, 47, 0 | 0.3 Micromoles per liter | Standard Deviation 4.8 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 26; n=48, 50, 53, 45 | 0.5 Micromoles per liter | Standard Deviation 3.81 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 28; n=51, 52, 52, 45 | 0.7 Micromoles per liter | Standard Deviation 5.19 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 40; n=52, 53, 55, 44 | 2.36 Micromoles per liter | Standard Deviation 8.318 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 180; n=36, 41, 47, 0 | 0.0 Micromoles per liter | Standard Deviation 4.29 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 32; n=52, 53, 55, 45 | 0.2 Micromoles per liter | Standard Deviation 4.99 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 36; n=52, 52, 55, 45 | 0.6 Micromoles per liter | Standard Deviation 4.92 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 264; n=32, 38, 47, 0 | 2.9 Micromoles per liter | Standard Deviation 8.95 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 168; n=35, 43, 47, 0 | 0.8 Micromoles per liter | Standard Deviation 4.19 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 40; n=52, 53, 55, 44 | 1.7 Micromoles per liter | Standard Deviation 4.75 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 48; n=51, 53, 54, 44 | 0.1 Micromoles per liter | Standard Deviation 4.51 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 48; n=51, 53, 54, 44 | 2.18 Micromoles per liter | Standard Deviation 8.28 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 156; n=37, 42, 49, 0 | 1.0 Micromoles per liter | Standard Deviation 5.23 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 60; n=48, 47, 53, 44 | 0.0 Micromoles per liter | Standard Deviation 4.78 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 72; n=47, 47, 52, 42 | 0.1 Micromoles per liter | Standard Deviation 4.59 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 144; n=37, 45, 47, 0 | 1.1 Micromoles per liter | Standard Deviation 7 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 84; n=46, 48, 52, 42 | 0.1 Micromoles per liter | Standard Deviation 5.07 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 96; n=45, 48, 52, 40 | 0.0 Micromoles per liter | Standard Deviation 5.8 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 60; n=48, 47, 53, 44 | 2.30 Micromoles per liter | Standard Deviation 7.998 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 132; n=40, 46, 49, 0 | 2.0 Micromoles per liter | Standard Deviation 8.03 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 108; n=43, 46, 48, 0 | 1.4 Micromoles per liter | Standard Deviation 6.34 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 12; n=58, 53, 57, 51 | 1.59 Micromoles per liter | Standard Deviation 9.3 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 120; n=40, 45, 48, 0 | 1.1 Micromoles per liter | Standard Deviation 4.72 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 252; n=31, 38, 46, 0 | 2.0 Micromoles per liter | Standard Deviation 6.03 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 72; n=47, 47, 52, 42 | 4.71 Micromoles per liter | Standard Deviation 7.934 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 84; n=46, 48, 52, 42 | 3.80 Micromoles per liter | Standard Deviation 8.761 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 312; n=31, 34, 43, 0 | 1.1 Micromoles per liter | Standard Deviation 7.12 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 240; n=30, 39, 46, 0 | 0.9 Micromoles per liter | Standard Deviation 4.72 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 96; n=45, 48, 52, 40 | 5.34 Micromoles per liter | Standard Deviation 10.813 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 108; n=43, 46, 48, 0 | 5.18 Micromoles per liter | Standard Deviation 7.296 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 16; n=57, 54, 57, 52 | 1.10 Micromoles per liter | Standard Deviation 6.923 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 120; n=40, 45, 48, 0 | 4.15 Micromoles per liter | Standard Deviation 7.099 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 132; n=40, 46, 49, 0 | 4.02 Micromoles per liter | Standard Deviation 6.551 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 144; n=37, 45, 47, 0 | 5.80 Micromoles per liter | Standard Deviation 6.861 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 156; n=37, 42, 49, 0 | 6.36 Micromoles per liter | Standard Deviation 6.819 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 20; n=56, 54, 55, 49 | 0.85 Micromoles per liter | Standard Deviation 7.713 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 168; n=35, 43, 47, 0 | 5.62 Micromoles per liter | Standard Deviation 8.355 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 4; n=58, 57, 59, 57 | 2.50 Micromoles per liter | Standard Deviation 7.401 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 180; n=36, 41, 47, 0 | 5.08 Micromoles per liter | Standard Deviation 7.638 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 300; n=30, 37, 44, 0 | 1.7 Micromoles per liter | Standard Deviation 8.78 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 204; n=34, 39, 47, 0 | 0.7 Micromoles per liter | Standard Deviation 3.71 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 204; n=34, 39, 47, 0 | 6.46 Micromoles per liter | Standard Deviation 8.491 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 24; n=56, 53, 56, 47 | 2.44 Micromoles per liter | Standard Deviation 9.391 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 216; n=33, 39, 46, 0 | 9.31 Micromoles per liter | Standard Deviation 10.863 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 2; n=58, 56, 58, 58 | 2.58 Micromoles per liter | Standard Deviation 7.273 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 228; n=32, 39, 47, 0 | 7.19 Micromoles per liter | Standard Deviation 7.388 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 240; n=30, 39, 46, 0 | 7.33 Micromoles per liter | Standard Deviation 9.459 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 252; n=31, 38, 46, 0 | 7.52 Micromoles per liter | Standard Deviation 9.245 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 26; n=48, 50, 53, 45 | 1.80 Micromoles per liter | Standard Deviation 8.796 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 264; n=32, 38, 47, 0 | 7.10 Micromoles per liter | Standard Deviation 9.486 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 324; n=3, 4, 3, 0 | 5.5 Micromoles per liter | Standard Deviation 11.47 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 276; n=31, 38, 45, 0 | 5.84 Micromoles per liter | Standard Deviation 10.581 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 288; n=31, 38, 45, 0 | 1.9 Micromoles per liter | Standard Deviation 7.87 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 288; n=31, 38, 45, 0 | 7.84 Micromoles per liter | Standard Deviation 9.546 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 300; n=30, 37, 44, 0 | 9.16 Micromoles per liter | Standard Deviation 9.58 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 28; n=51, 52, 52, 45 | 2.80 Micromoles per liter | Standard Deviation 8.908 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 312; n=31, 34, 43, 0 | 7.86 Micromoles per liter | Standard Deviation 9.096 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 324; n=3, 4, 3, 0 | 9.75 Micromoles per liter | Standard Deviation 8.155 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 2; n=58, 56, 58, 58 | -0.3 Micromoles per liter | Standard Deviation 2.71 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 228; n=32, 39, 47, 0 | 0.5 Micromoles per liter | Standard Deviation 3.77 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 4; n=58, 57, 59, 57 | -0.3 Micromoles per liter | Standard Deviation 3.9 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 32; n=52, 53, 55, 45 | 1.69 Micromoles per liter | Standard Deviation 9.226 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 8; n=58, 55, 57, 54 | -0.5 Micromoles per liter | Standard Deviation 3.83 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 8; n=58, 55, 57, 54 | 2.06 Micromoles per liter | Standard Deviation 6.775 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 216; n=33, 39, 46, 0 | 0.8 Micromoles per liter | Standard Deviation 6.69 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 12; n=58, 53, 57, 51 | -0.9 Micromoles per liter | Standard Deviation 3.77 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 276; n=31, 38, 45, 0 | 2.8 Micromoles per liter | Standard Deviation 10.4 |
| GSK1265744 30 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 16; n=57, 54, 57, 52 | -1.2 Micromoles per liter | Standard Deviation 3.74 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 324; n=3, 4, 3, 0 | 0.7 Micromoles per liter | Standard Deviation 4.16 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 2; n=58, 56, 58, 58 | 4.15 Micromoles per liter | Standard Deviation 6.508 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 4; n=58, 57, 59, 57 | 4.08 Micromoles per liter | Standard Deviation 8.072 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 8; n=58, 55, 57, 54 | 3.44 Micromoles per liter | Standard Deviation 8.717 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 12; n=58, 53, 57, 51 | 3.79 Micromoles per liter | Standard Deviation 8.634 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 16; n=57, 54, 57, 52 | 2.09 Micromoles per liter | Standard Deviation 8.967 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 20; n=56, 54, 55, 49 | 5.29 Micromoles per liter | Standard Deviation 9.36 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 24; n=56, 53, 56, 47 | 4.45 Micromoles per liter | Standard Deviation 9.743 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 26; n=48, 50, 53, 45 | 6.03 Micromoles per liter | Standard Deviation 8.465 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 28; n=51, 52, 52, 45 | 5.01 Micromoles per liter | Standard Deviation 9.028 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 32; n=52, 53, 55, 45 | 5.00 Micromoles per liter | Standard Deviation 8.69 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 36; n=52, 52, 55, 45 | 6.00 Micromoles per liter | Standard Deviation 8.059 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 40; n=52, 53, 55, 44 | 4.76 Micromoles per liter | Standard Deviation 7.858 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 48; n=51, 53, 54, 44 | 4.47 Micromoles per liter | Standard Deviation 7.883 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 60; n=48, 47, 53, 44 | 4.46 Micromoles per liter | Standard Deviation 9.058 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 72; n=47, 47, 52, 42 | 6.59 Micromoles per liter | Standard Deviation 10.595 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 84; n=46, 48, 52, 42 | 6.53 Micromoles per liter | Standard Deviation 8.328 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 96; n=45, 48, 52, 40 | 7.76 Micromoles per liter | Standard Deviation 10.318 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 108; n=43, 46, 48, 0 | 7.26 Micromoles per liter | Standard Deviation 10.273 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 120; n=40, 45, 48, 0 | 6.78 Micromoles per liter | Standard Deviation 11.811 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 132; n=40, 46, 49, 0 | 4.99 Micromoles per liter | Standard Deviation 12.168 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 144; n=37, 45, 47, 0 | 5.07 Micromoles per liter | Standard Deviation 10.449 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 156; n=37, 42, 49, 0 | 5.16 Micromoles per liter | Standard Deviation 9.056 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 168; n=35, 43, 47, 0 | 6.82 Micromoles per liter | Standard Deviation 9.644 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 180; n=36, 41, 47, 0 | 5.91 Micromoles per liter | Standard Deviation 11.737 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 192; n=36, 39, 47, 0 | 5.90 Micromoles per liter | Standard Deviation 11.316 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 204; n=34, 39, 47, 0 | 5.16 Micromoles per liter | Standard Deviation 10.629 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 216; n=33, 39, 46, 0 | 7.42 Micromoles per liter | Standard Deviation 8.996 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 228; n=32, 39, 47, 0 | 6.61 Micromoles per liter | Standard Deviation 10.415 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 240; n=30, 39, 46, 0 | 7.08 Micromoles per liter | Standard Deviation 10.649 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 252; n=31, 38, 46, 0 | 7.64 Micromoles per liter | Standard Deviation 11.727 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 264; n=32, 38, 47, 0 | 6.99 Micromoles per liter | Standard Deviation 12.14 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 276; n=31, 38, 45, 0 | 6.19 Micromoles per liter | Standard Deviation 10.418 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 288; n=31, 38, 45, 0 | 6.20 Micromoles per liter | Standard Deviation 12.89 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 300; n=30, 37, 44, 0 | 8.19 Micromoles per liter | Standard Deviation 12.114 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 312; n=31, 34, 43, 0 | 7.10 Micromoles per liter | Standard Deviation 12.061 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 324; n=3, 4, 3, 0 | 5.03 Micromoles per liter | Standard Deviation 4.007 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 2; n=58, 56, 58, 58 | -0.4 Micromoles per liter | Standard Deviation 4.89 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 4; n=58, 57, 59, 57 | -0.8 Micromoles per liter | Standard Deviation 5.9 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 8; n=58, 55, 57, 54 | -0.6 Micromoles per liter | Standard Deviation 5.62 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 12; n=58, 53, 57, 51 | -0.5 Micromoles per liter | Standard Deviation 5.61 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 16; n=57, 54, 57, 52 | -0.2 Micromoles per liter | Standard Deviation 4.93 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 20; n=56, 54, 55, 49 | -0.4 Micromoles per liter | Standard Deviation 7.27 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 24; n=56, 53, 56, 47 | -0.7 Micromoles per liter | Standard Deviation 5.69 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 26; n=48, 50, 53, 45 | 1.0 Micromoles per liter | Standard Deviation 5.8 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 28; n=51, 52, 52, 45 | 0.5 Micromoles per liter | Standard Deviation 5.25 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 32; n=52, 53, 55, 45 | 0.9 Micromoles per liter | Standard Deviation 6.82 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 36; n=52, 52, 55, 45 | 1.4 Micromoles per liter | Standard Deviation 6.4 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 40; n=52, 53, 55, 44 | 1.5 Micromoles per liter | Standard Deviation 6.3 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 48; n=51, 53, 54, 44 | -0.3 Micromoles per liter | Standard Deviation 5.37 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 60; n=48, 47, 53, 44 | 0.9 Micromoles per liter | Standard Deviation 6.56 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 72; n=47, 47, 52, 42 | 0.6 Micromoles per liter | Standard Deviation 6.36 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 84; n=46, 48, 52, 42 | 1.2 Micromoles per liter | Standard Deviation 5.49 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 96; n=45, 48, 52, 40 | 1.7 Micromoles per liter | Standard Deviation 5.42 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 108; n=43, 46, 48, 0 | 0.8 Micromoles per liter | Standard Deviation 5.89 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 120; n=40, 45, 48, 0 | 1.3 Micromoles per liter | Standard Deviation 7.4 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 132; n=40, 46, 49, 0 | 1.1 Micromoles per liter | Standard Deviation 6.4 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 144; n=37, 45, 47, 0 | 0.4 Micromoles per liter | Standard Deviation 6.5 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 156; n=37, 42, 49, 0 | 1.0 Micromoles per liter | Standard Deviation 6.93 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 168; n=35, 43, 47, 0 | 1.4 Micromoles per liter | Standard Deviation 5.94 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 180; n=36, 41, 47, 0 | 1.0 Micromoles per liter | Standard Deviation 7.42 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 192; n=36, 39, 47, 0 | 0.9 Micromoles per liter | Standard Deviation 6.18 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 204; n=34, 39, 47, 0 | 0.6 Micromoles per liter | Standard Deviation 6.61 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 216; n=33, 39, 46, 0 | 0.3 Micromoles per liter | Standard Deviation 5.91 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 228; n=32, 39, 47, 0 | -0.3 Micromoles per liter | Standard Deviation 5.71 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 240; n=30, 39, 46, 0 | -0.1 Micromoles per liter | Standard Deviation 4.83 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 252; n=31, 38, 46, 0 | 0.2 Micromoles per liter | Standard Deviation 6.21 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 264; n=32, 38, 47, 0 | -0.1 Micromoles per liter | Standard Deviation 6.11 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 276; n=31, 38, 45, 0 | 0.9 Micromoles per liter | Standard Deviation 6.46 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 288; n=31, 38, 45, 0 | 0.0 Micromoles per liter | Standard Deviation 6.1 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 300; n=30, 37, 44, 0 | 0.9 Micromoles per liter | Standard Deviation 5.18 |
| GSK1265744 60 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 312; n=31, 34, 43, 0 | 0.8 Micromoles per liter | Standard Deviation 5.52 |
| Efavirenz 600 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 26; n=48, 50, 53, 45 | -2.67 Micromoles per liter | Standard Deviation 9.311 |
| Efavirenz 600 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 20; n=56, 54, 55, 49 | -2.6 Micromoles per liter | Standard Deviation 3.83 |
| Efavirenz 600 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 16; n=57, 54, 57, 52 | -2.4 Micromoles per liter | Standard Deviation 3.79 |
| Efavirenz 600 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 8; n=58, 55, 57, 54 | -0.92 Micromoles per liter | Standard Deviation 9.006 |
| Efavirenz 600 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 12; n=58, 53, 57, 51 | -2.4 Micromoles per liter | Standard Deviation 3.75 |
| Efavirenz 600 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 8; n=58, 55, 57, 54 | -3.4 Micromoles per liter | Standard Deviation 4.24 |
| Efavirenz 600 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 24; n=56, 53, 56, 47 | -2.03 Micromoles per liter | Standard Deviation 15.306 |
| Efavirenz 600 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 4; n=58, 57, 59, 57 | -3.4 Micromoles per liter | Standard Deviation 4.06 |
| Efavirenz 600 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 2; n=58, 56, 58, 58 | -3.0 Micromoles per liter | Standard Deviation 3.82 |
| Efavirenz 600 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 20; n=56, 54, 55, 49 | -3.26 Micromoles per liter | Standard Deviation 8.085 |
| Efavirenz 600 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 96; n=45, 48, 52, 40 | -2.28 Micromoles per liter | Standard Deviation 10.222 |
| Efavirenz 600 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 84; n=46, 48, 52, 42 | -2.48 Micromoles per liter | Standard Deviation 8.697 |
| Efavirenz 600 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 4; n=58, 57, 59, 57 | -0.32 Micromoles per liter | Standard Deviation 5.817 |
| Efavirenz 600 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 72; n=47, 47, 52, 42 | -4.48 Micromoles per liter | Standard Deviation 8.461 |
| Efavirenz 600 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 60; n=48, 47, 53, 44 | -3.87 Micromoles per liter | Standard Deviation 7.866 |
| Efavirenz 600 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 16; n=57, 54, 57, 52 | -2.92 Micromoles per liter | Standard Deviation 7.744 |
| Efavirenz 600 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 48; n=51, 53, 54, 44 | -2.73 Micromoles per liter | Standard Deviation 8.533 |
| Efavirenz 600 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 40; n=52, 53, 55, 44 | -2.83 Micromoles per liter | Standard Deviation 9.423 |
| Efavirenz 600 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 96; n=45, 48, 52, 40 | -2.5 Micromoles per liter | Standard Deviation 3.92 |
| Efavirenz 600 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 12; n=58, 53, 57, 51 | -1.42 Micromoles per liter | Standard Deviation 9.022 |
| Efavirenz 600 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 84; n=46, 48, 52, 42 | -2.6 Micromoles per liter | Standard Deviation 4.27 |
| Efavirenz 600 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 72; n=47, 47, 52, 42 | -2.7 Micromoles per liter | Standard Deviation 3.69 |
| Efavirenz 600 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 36; n=52, 52, 55, 45 | -3.26 Micromoles per liter | Standard Deviation 7.392 |
| Efavirenz 600 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 60; n=48, 47, 53, 44 | -2.2 Micromoles per liter | Standard Deviation 3.86 |
| Efavirenz 600 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 48; n=51, 53, 54, 44 | -2.6 Micromoles per liter | Standard Deviation 3.8 |
| Efavirenz 600 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 32; n=52, 53, 55, 45 | -3.50 Micromoles per liter | Standard Deviation 7.887 |
| Efavirenz 600 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 40; n=52, 53, 55, 44 | -2.9 Micromoles per liter | Standard Deviation 3.67 |
| Efavirenz 600 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 36; n=52, 52, 55, 45 | -2.7 Micromoles per liter | Standard Deviation 3.62 |
| Efavirenz 600 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 2; n=58, 56, 58, 58 | 0.65 Micromoles per liter | Standard Deviation 7.483 |
| Efavirenz 600 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 32; n=52, 53, 55, 45 | -2.6 Micromoles per liter | Standard Deviation 3.78 |
| Efavirenz 600 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 28; n=51, 52, 52, 45 | -2.8 Micromoles per liter | Standard Deviation 4.01 |
| Efavirenz 600 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | Creatinine; Week 28; n=51, 52, 52, 45 | -3.42 Micromoles per liter | Standard Deviation 8.042 |
| Efavirenz 600 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 26; n=48, 50, 53, 45 | -2.7 Micromoles per liter | Standard Deviation 3.44 |
| Efavirenz 600 mg | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit | T. Bilirubin; Week 24; n=56, 53, 56, 47 | -2.9 Micromoles per liter | Standard Deviation 3.86 |
Secondary
Change From Baseline in Estimated Creatinine Clearance Over Time by Visit
Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
Time frame: Baseline (Day 1) and Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60, 96, 180, 204, 252 and 264
Population: Safety Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1265744 10 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 2; n=1, 1, 0, 3 | -3.0 Milliliters per minute | — |
| GSK1265744 10 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 24; n=52, 53, 55, 46 | -2.7 Milliliters per minute | Standard Deviation 22.03 |
| GSK1265744 10 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 16; n=55, 53, 56, 49 | 2.2 Milliliters per minute | Standard Deviation 37.66 |
| GSK1265744 10 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 180; n=1, 0, 0, 0 | 1.0 Milliliters per minute | — |
| GSK1265744 10 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 20; n=2, 0, 0, 1 | 8.0 Milliliters per minute | Standard Deviation 7.07 |
| GSK1265744 10 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 96; n=45, 48, 52, 40 | 2.2 Milliliters per minute | Standard Deviation 31.7 |
| GSK1265744 10 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 48; n=51, 50, 54, 44 | -2.6 Milliliters per minute | Standard Deviation 12.72 |
| GSK1265744 10 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 8; n=2, 1, 1, 1 | 5.5 Milliliters per minute | Standard Deviation 26.16 |
| GSK1265744 10 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 4; n=58, 57, 59, 57 | -1.4 Milliliters per minute | Standard Deviation 12.2 |
| GSK1265744 30 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 24; n=52, 53, 55, 46 | -6.4 Milliliters per minute | Standard Deviation 34.13 |
| GSK1265744 30 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 2; n=1, 1, 0, 3 | -10.0 Milliliters per minute | — |
| GSK1265744 30 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 4; n=58, 57, 59, 57 | -3.7 Milliliters per minute | Standard Deviation 12.18 |
| GSK1265744 30 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 8; n=2, 1, 1, 1 | -1.0 Milliliters per minute | — |
| GSK1265744 30 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 16; n=55, 53, 56, 49 | 0.2 Milliliters per minute | Standard Deviation 15.6 |
| GSK1265744 30 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 26; n=0, 1, 0, 0 | -7.0 Milliliters per minute | — |
| GSK1265744 30 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 40; n=0, 1, 0, 0 | -95.0 Milliliters per minute | — |
| GSK1265744 30 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 48; n=51, 50, 54, 44 | -1.1 Milliliters per minute | Standard Deviation 16.63 |
| GSK1265744 30 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 96; n=45, 48, 52, 40 | -2.4 Milliliters per minute | Standard Deviation 20.43 |
| GSK1265744 30 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 204; n=0, 1, 0, 0 | -23.0 Milliliters per minute | — |
| GSK1265744 30 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 252; n=0, 1, 0, 0 | 0.0 Milliliters per minute | — |
| GSK1265744 60 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 24; n=52, 53, 55, 46 | -5.8 Milliliters per minute | Standard Deviation 14.77 |
| GSK1265744 60 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 96; n=45, 48, 52, 40 | -9.0 Milliliters per minute | Standard Deviation 16.95 |
| GSK1265744 60 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 48; n=51, 50, 54, 44 | -4.5 Milliliters per minute | Standard Deviation 14.27 |
| GSK1265744 60 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 4; n=58, 57, 59, 57 | -4.9 Milliliters per minute | Standard Deviation 14.83 |
| GSK1265744 60 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 264; n=0, 0, 1, 0 | -143.0 Milliliters per minute | — |
| GSK1265744 60 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 16; n=55, 53, 56, 49 | -2.7 Milliliters per minute | Standard Deviation 13.89 |
| GSK1265744 60 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 8; n=2, 1, 1, 1 | 7.0 Milliliters per minute | — |
| Efavirenz 600 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 60; n=0, 0, 0, 1 | 16.0 Milliliters per minute | — |
| Efavirenz 600 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 20; n=2, 0, 0, 1 | 4.0 Milliliters per minute | — |
| Efavirenz 600 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 8; n=2, 1, 1, 1 | 0.0 Milliliters per minute | — |
| Efavirenz 600 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 16; n=55, 53, 56, 49 | 3.4 Milliliters per minute | Standard Deviation 12.94 |
| Efavirenz 600 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 96; n=45, 48, 52, 40 | 5.1 Milliliters per minute | Standard Deviation 22.48 |
| Efavirenz 600 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 4; n=58, 57, 59, 57 | -0.1 Milliliters per minute | Standard Deviation 10.06 |
| Efavirenz 600 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 2; n=1, 1, 0, 3 | -0.7 Milliliters per minute | Standard Deviation 0.58 |
| Efavirenz 600 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 24; n=52, 53, 55, 46 | 4.8 Milliliters per minute | Standard Deviation 15.66 |
| Efavirenz 600 mg | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit | Week 48; n=51, 50, 54, 44 | 0.4 Milliliters per minute | Standard Deviation 19.04 |
Secondary
Change From Baseline in Hemoglobin Level Over Time by Visit
Blood samples were collected for the analysis of hemoglobin level. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
Time frame: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Population: Safety Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 120; n=41, 46, 49, 0 | 4.2 Grams per liter | Standard Deviation 11.11 |
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 72; n=47, 48, 52, 42 | 1.8 Grams per liter | Standard Deviation 11.28 |
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 252; n=31, 36, 45, 0 | 6.2 Grams per liter | Standard Deviation 14.98 |
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 192; n=35, 40, 47, 0 | 3.3 Grams per liter | Standard Deviation 13.07 |
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 84; n=46, 48, 51, 42 | 3.3 Grams per liter | Standard Deviation 11.53 |
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 144; n=37, 45, 46, 0 | 4.0 Grams per liter | Standard Deviation 12.08 |
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 96; n=46, 46, 52, 41 | 2.7 Grams per liter | Standard Deviation 13.41 |
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 4; n=57, 57, 59, 57 | -0.2 Grams per liter | Standard Deviation 6.41 |
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 180; n=36, 41, 47, 0 | 5.5 Grams per liter | Standard Deviation 11.79 |
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 108; n=43, 46, 49, 0 | 4.0 Grams per liter | Standard Deviation 11.77 |
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 132; n=40, 46, 49, 0 | 3.5 Grams per liter | Standard Deviation 10.89 |
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 8; n=58, 56, 56, 55 | 2.7 Grams per liter | Standard Deviation 9.19 |
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 168; n=35, 43, 47, 0 | 6.3 Grams per liter | Standard Deviation 12.6 |
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 156; n=37, 42, 49, 0 | 4.0 Grams per liter | Standard Deviation 11.55 |
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 324; n=3, 4, 2, 0 | 4.3 Grams per liter | Standard Deviation 9.07 |
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 12; n=58, 53, 57, 51 | 2.0 Grams per liter | Standard Deviation 8.27 |
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 264; n=32, 38, 46, 0 | 6.3 Grams per liter | Standard Deviation 14.69 |
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 16; n=57, 54, 57, 52 | 1.1 Grams per liter | Standard Deviation 7.58 |
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 312; n=31, 33, 42, 0 | 7.0 Grams per liter | Standard Deviation 13.56 |
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 20; n=56, 54, 55, 49 | 2.1 Grams per liter | Standard Deviation 8.78 |
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 240; n=32, 39, 47, 0 | 6.2 Grams per liter | Standard Deviation 14.38 |
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 24; n=56, 53, 56, 47 | 2.6 Grams per liter | Standard Deviation 9.17 |
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 276; n=31, 38, 46, 0 | 6.6 Grams per liter | Standard Deviation 14.67 |
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 300; n=30, 37, 43, 0 | 4.6 Grams per liter | Standard Deviation 15.39 |
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 26; n=48, 50, 53, 45 | 1.8 Grams per liter | Standard Deviation 7.68 |
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 28; n=50, 52, 52, 45 | 1.7 Grams per liter | Standard Deviation 8.51 |
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 228; n=31, 39, 47, 0 | 5.1 Grams per liter | Standard Deviation 13.32 |
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 32; n=51, 53, 55, 45 | 1.6 Grams per liter | Standard Deviation 8.64 |
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 288; n=30, 38, 44, 0 | 7.3 Grams per liter | Standard Deviation 12.51 |
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 36; n=52, 53, 55, 44 | 0.3 Grams per liter | Standard Deviation 10.21 |
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 216; n=32, 39, 44, 0 | 4.7 Grams per liter | Standard Deviation 14.1 |
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 40; n=51, 53, 55, 45 | 0.5 Grams per liter | Standard Deviation 11.44 |
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 48; n=51, 53, 54, 44 | 1.2 Grams per liter | Standard Deviation 9.84 |
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 2; n=57, 56, 59, 59 | 0.1 Grams per liter | Standard Deviation 6.66 |
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 204; n=34, 39, 47, 0 | 4.5 Grams per liter | Standard Deviation 12.73 |
| GSK1265744 10 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 60; n=48, 47, 52, 44 | 2.6 Grams per liter | Standard Deviation 11.23 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 16; n=57, 54, 57, 52 | 3.5 Grams per liter | Standard Deviation 7.55 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 2; n=57, 56, 59, 59 | 0.0 Grams per liter | Standard Deviation 6.25 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 192; n=35, 40, 47, 0 | 3.5 Grams per liter | Standard Deviation 9.55 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 264; n=32, 38, 46, 0 | 6.0 Grams per liter | Standard Deviation 9.28 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 72; n=47, 48, 52, 42 | 4.5 Grams per liter | Standard Deviation 7.39 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 204; n=34, 39, 47, 0 | 4.7 Grams per liter | Standard Deviation 9.84 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 48; n=51, 53, 54, 44 | 2.7 Grams per liter | Standard Deviation 8.4 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 20; n=56, 54, 55, 49 | 3.8 Grams per liter | Standard Deviation 9.28 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 84; n=46, 48, 51, 42 | 4.0 Grams per liter | Standard Deviation 8.37 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 32; n=51, 53, 55, 45 | 3.1 Grams per liter | Standard Deviation 8.71 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 180; n=36, 41, 47, 0 | 4.0 Grams per liter | Standard Deviation 9.23 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 300; n=30, 37, 43, 0 | 5.1 Grams per liter | Standard Deviation 10.47 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 96; n=46, 46, 52, 41 | 3.3 Grams per liter | Standard Deviation 6.94 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 40; n=51, 53, 55, 45 | 2.2 Grams per liter | Standard Deviation 8.56 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 24; n=56, 53, 56, 47 | 4.8 Grams per liter | Standard Deviation 7.66 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 216; n=32, 39, 44, 0 | 4.1 Grams per liter | Standard Deviation 9.97 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 108; n=43, 46, 49, 0 | 3.4 Grams per liter | Standard Deviation 9.42 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 4; n=57, 57, 59, 57 | 0.5 Grams per liter | Standard Deviation 5.61 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 60; n=48, 47, 52, 44 | 4.7 Grams per liter | Standard Deviation 8.73 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 120; n=41, 46, 49, 0 | 4.7 Grams per liter | Standard Deviation 8.72 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 252; n=31, 36, 45, 0 | 6.4 Grams per liter | Standard Deviation 11.76 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 144; n=37, 45, 46, 0 | 2.6 Grams per liter | Standard Deviation 10.64 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 132; n=40, 46, 49, 0 | 3.0 Grams per liter | Standard Deviation 9.9 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 324; n=3, 4, 2, 0 | 10.0 Grams per liter | Standard Deviation 14.33 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 156; n=37, 42, 49, 0 | 5.1 Grams per liter | Standard Deviation 9.76 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 36; n=52, 53, 55, 44 | 2.9 Grams per liter | Standard Deviation 9.69 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 26; n=48, 50, 53, 45 | 3.4 Grams per liter | Standard Deviation 8 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 168; n=35, 43, 47, 0 | 6.0 Grams per liter | Standard Deviation 10.91 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 8; n=58, 56, 56, 55 | 4.8 Grams per liter | Standard Deviation 7.23 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 276; n=31, 38, 46, 0 | 5.5 Grams per liter | Standard Deviation 11.06 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 228; n=31, 39, 47, 0 | 4.8 Grams per liter | Standard Deviation 10.55 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 288; n=30, 38, 44, 0 | 6.8 Grams per liter | Standard Deviation 11.38 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 12; n=58, 53, 57, 51 | 3.9 Grams per liter | Standard Deviation 7.84 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 28; n=50, 52, 52, 45 | 4.0 Grams per liter | Standard Deviation 7.93 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 312; n=31, 33, 42, 0 | 6.1 Grams per liter | Standard Deviation 9.29 |
| GSK1265744 30 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 240; n=32, 39, 47, 0 | 5.8 Grams per liter | Standard Deviation 10.64 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 324; n=3, 4, 2, 0 | 20.5 Grams per liter | Standard Deviation 7.78 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 144; n=37, 45, 46, 0 | 2.3 Grams per liter | Standard Deviation 11.37 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 240; n=32, 39, 47, 0 | 2.1 Grams per liter | Standard Deviation 11.7 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 252; n=31, 36, 45, 0 | 5.8 Grams per liter | Standard Deviation 10.33 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 264; n=32, 38, 46, 0 | 5.5 Grams per liter | Standard Deviation 11.07 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 276; n=31, 38, 46, 0 | 5.4 Grams per liter | Standard Deviation 10.02 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 288; n=30, 38, 44, 0 | 6.9 Grams per liter | Standard Deviation 10.82 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 2; n=57, 56, 59, 59 | -0.7 Grams per liter | Standard Deviation 6.61 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 4; n=57, 57, 59, 57 | 0.6 Grams per liter | Standard Deviation 7.67 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 8; n=58, 56, 56, 55 | 2.0 Grams per liter | Standard Deviation 8.99 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 12; n=58, 53, 57, 51 | 2.6 Grams per liter | Standard Deviation 9.59 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 16; n=57, 54, 57, 52 | 2.3 Grams per liter | Standard Deviation 9.61 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 20; n=56, 54, 55, 49 | 3.1 Grams per liter | Standard Deviation 9.66 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 24; n=56, 53, 56, 47 | 3.6 Grams per liter | Standard Deviation 11.04 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 26; n=48, 50, 53, 45 | 2.5 Grams per liter | Standard Deviation 9.17 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 28; n=50, 52, 52, 45 | 1.5 Grams per liter | Standard Deviation 8.5 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 32; n=51, 53, 55, 45 | 3.5 Grams per liter | Standard Deviation 8.49 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 36; n=52, 53, 55, 44 | 2.7 Grams per liter | Standard Deviation 11.59 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 40; n=51, 53, 55, 45 | 2.1 Grams per liter | Standard Deviation 9.46 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 48; n=51, 53, 54, 44 | -0.5 Grams per liter | Standard Deviation 12.03 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 60; n=48, 47, 52, 44 | 2.2 Grams per liter | Standard Deviation 11.45 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 72; n=47, 48, 52, 42 | 2.4 Grams per liter | Standard Deviation 10.08 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 84; n=46, 48, 51, 42 | 3.0 Grams per liter | Standard Deviation 11.34 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 96; n=46, 46, 52, 41 | 3.6 Grams per liter | Standard Deviation 10.11 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 108; n=43, 46, 49, 0 | 3.0 Grams per liter | Standard Deviation 10.98 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 120; n=41, 46, 49, 0 | 2.1 Grams per liter | Standard Deviation 11.39 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 132; n=40, 46, 49, 0 | 2.5 Grams per liter | Standard Deviation 12.41 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 156; n=37, 42, 49, 0 | 2.7 Grams per liter | Standard Deviation 11.88 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 168; n=35, 43, 47, 0 | 4.8 Grams per liter | Standard Deviation 10.6 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 180; n=36, 41, 47, 0 | 2.7 Grams per liter | Standard Deviation 11.68 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 192; n=35, 40, 47, 0 | 3.0 Grams per liter | Standard Deviation 11.51 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 204; n=34, 39, 47, 0 | 3.2 Grams per liter | Standard Deviation 11.65 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 216; n=32, 39, 44, 0 | 3.4 Grams per liter | Standard Deviation 10.6 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 228; n=31, 39, 47, 0 | 3.1 Grams per liter | Standard Deviation 10.53 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 300; n=30, 37, 43, 0 | 5.5 Grams per liter | Standard Deviation 11.56 |
| GSK1265744 60 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 312; n=31, 33, 42, 0 | 8.0 Grams per liter | Standard Deviation 10.1 |
| Efavirenz 600 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 40; n=51, 53, 55, 45 | -0.2 Grams per liter | Standard Deviation 7.67 |
| Efavirenz 600 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 12; n=58, 53, 57, 51 | 2.8 Grams per liter | Standard Deviation 8.57 |
| Efavirenz 600 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 36; n=52, 53, 55, 44 | -0.8 Grams per liter | Standard Deviation 9.79 |
| Efavirenz 600 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 32; n=51, 53, 55, 45 | 0.6 Grams per liter | Standard Deviation 8.92 |
| Efavirenz 600 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 2; n=57, 56, 59, 59 | 0.7 Grams per liter | Standard Deviation 6.9 |
| Efavirenz 600 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 28; n=50, 52, 52, 45 | 0.1 Grams per liter | Standard Deviation 10.5 |
| Efavirenz 600 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 26; n=48, 50, 53, 45 | 2.2 Grams per liter | Standard Deviation 8.11 |
| Efavirenz 600 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 8; n=58, 56, 56, 55 | 2.0 Grams per liter | Standard Deviation 9.18 |
| Efavirenz 600 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 24; n=56, 53, 56, 47 | 1.9 Grams per liter | Standard Deviation 8.16 |
| Efavirenz 600 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 20; n=56, 54, 55, 49 | 0.8 Grams per liter | Standard Deviation 9.22 |
| Efavirenz 600 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 96; n=46, 46, 52, 41 | 1.9 Grams per liter | Standard Deviation 10.06 |
| Efavirenz 600 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 84; n=46, 48, 51, 42 | 1.7 Grams per liter | Standard Deviation 9.65 |
| Efavirenz 600 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 4; n=57, 57, 59, 57 | 0.7 Grams per liter | Standard Deviation 6.4 |
| Efavirenz 600 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 72; n=47, 48, 52, 42 | 2.4 Grams per liter | Standard Deviation 9.15 |
| Efavirenz 600 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 60; n=48, 47, 52, 44 | 2.3 Grams per liter | Standard Deviation 9.18 |
| Efavirenz 600 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 16; n=57, 54, 57, 52 | 1.1 Grams per liter | Standard Deviation 9.22 |
| Efavirenz 600 mg | Change From Baseline in Hemoglobin Level Over Time by Visit | Week 48; n=51, 53, 54, 44 | 0.0 Grams per liter | Standard Deviation 9.52 |
Secondary
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit
Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
Time frame: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Population: ITT-E Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 20; n=56, 54, 56, 47 | -2.823 Log10 copies per milliliter | Standard Deviation 0.5329 |
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 312; n=31, 33, 43, 0 | -2.780 Log10 copies per milliliter | Standard Deviation 0.5085 |
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 96; n=45, 48, 52, 40 | -2.670 Log10 copies per milliliter | Standard Deviation 0.5277 |
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 84; n=46, 48, 52, 42 | -2.722 Log10 copies per milliliter | Standard Deviation 0.565 |
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 24; n=56, 53, 56, 48 | -2.831 Log10 copies per milliliter | Standard Deviation 0.5465 |
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 252; n=31, 38, 47, 0 | -2.787 Log10 copies per milliliter | Standard Deviation 0.5092 |
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 72; n=47, 48, 52, 42 | -2.745 Log10 copies per milliliter | Standard Deviation 0.5229 |
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 60; n=48, 48, 53, 44 | -2.729 Log10 copies per milliliter | Standard Deviation 0.6405 |
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 26; n=48, 50, 53, 44 | -2.788 Log10 copies per milliliter | Standard Deviation 0.5023 |
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 204; n=34, 39, 47, 0 | -2.750 Log10 copies per milliliter | Standard Deviation 0.5359 |
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 48; n=51, 53, 54, 44 | -2.682 Log10 copies per milliliter | Standard Deviation 0.6637 |
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 40; n=52, 53, 55, 45 | -2.760 Log10 copies per milliliter | Standard Deviation 0.5143 |
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 28; n=51, 52, 52, 45 | -2.784 Log10 copies per milliliter | Standard Deviation 0.4944 |
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 36; n=52, 53, 55, 45 | -2.768 Log10 copies per milliliter | Standard Deviation 0.5 |
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 32; n=52, 53, 55, 45 | -2.763 Log10 copies per milliliter | Standard Deviation 0.5164 |
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 300; n=31, 37, 44, 0 | -2.776 Log10 copies per milliliter | Standard Deviation 0.5062 |
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 240; n=31, 39, 45, 0 | -2.798 Log10 copies per milliliter | Standard Deviation 0.4923 |
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 264; n=32, 38, 47, 0 | -2.780 Log10 copies per milliliter | Standard Deviation 0.5022 |
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 288; n=30, 38, 45, 0 | -2.768 Log10 copies per milliliter | Standard Deviation 0.5083 |
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 2; n=57, 56, 59, 59 | -2.534 Log10 copies per milliliter | Standard Deviation 0.4175 |
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 276; n=31, 38, 45, 0 | -2.786 Log10 copies per milliliter | Standard Deviation 0.5095 |
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 228; n=32, 39, 47, 0 | -2.770 Log10 copies per milliliter | Standard Deviation 0.494 |
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 216; n=33, 39, 47, 0 | -2.787 Log10 copies per milliliter | Standard Deviation 0.4956 |
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 192; n=36, 40, 47, 0 | -2.671 Log10 copies per milliliter | Standard Deviation 0.6656 |
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 180; n=36, 41, 47, 0 | -2.747 Log10 copies per milliliter | Standard Deviation 0.4984 |
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 8; n=59, 56, 57, 55 | -2.733 Log10 copies per milliliter | Standard Deviation 0.6374 |
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 144; n=37, 45, 47, 0 | -2.690 Log10 copies per milliliter | Standard Deviation 0.6615 |
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 168; n=35, 43, 47, 0 | -2.680 Log10 copies per milliliter | Standard Deviation 0.617 |
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 156; n=37, 42, 49, 0 | -2.737 Log10 copies per milliliter | Standard Deviation 0.5476 |
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 12; n=58, 52, 57, 51 | -2.793 Log10 copies per milliliter | Standard Deviation 0.5574 |
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 4; n=58, 57, 59, 57 | -2.731 Log10 copies per milliliter | Standard Deviation 0.4158 |
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 132; n=40, 46, 49, 0 | -2.705 Log10 copies per milliliter | Standard Deviation 0.5504 |
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 16; n=57, 54, 57, 52 | -2.823 Log10 copies per milliliter | Standard Deviation 0.5118 |
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 324; n=3, 4, 3, 0 | -2.488 Log10 copies per milliliter | Standard Deviation 0.1409 |
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 120; n=41, 46, 49, 0 | -2.712 Log10 copies per milliliter | Standard Deviation 0.5477 |
| GSK1265744 10 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 108; n=43, 46, 49, 0 | -2.723 Log10 copies per milliliter | Standard Deviation 0.5396 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 12; n=58, 52, 57, 51 | -2.634 Log10 copies per milliliter | Standard Deviation 0.6308 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 4; n=58, 57, 59, 57 | -2.550 Log10 copies per milliliter | Standard Deviation 0.63 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 32; n=52, 53, 55, 45 | -2.636 Log10 copies per milliliter | Standard Deviation 0.6598 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 144; n=37, 45, 47, 0 | -2.555 Log10 copies per milliliter | Standard Deviation 0.9008 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 168; n=35, 43, 47, 0 | -2.592 Log10 copies per milliliter | Standard Deviation 0.7138 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 204; n=34, 39, 47, 0 | -2.632 Log10 copies per milliliter | Standard Deviation 0.6353 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 240; n=31, 39, 45, 0 | -2.627 Log10 copies per milliliter | Standard Deviation 0.6181 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 288; n=30, 38, 45, 0 | -2.659 Log10 copies per milliliter | Standard Deviation 0.6246 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 2; n=57, 56, 59, 59 | -2.306 Log10 copies per milliliter | Standard Deviation 0.5937 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 8; n=59, 56, 57, 55 | -2.611 Log10 copies per milliliter | Standard Deviation 0.6938 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 16; n=57, 54, 57, 52 | -2.659 Log10 copies per milliliter | Standard Deviation 0.6363 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 20; n=56, 54, 56, 47 | -2.665 Log10 copies per milliliter | Standard Deviation 0.6418 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 24; n=56, 53, 56, 48 | -2.659 Log10 copies per milliliter | Standard Deviation 0.6488 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 26; n=48, 50, 53, 44 | -2.662 Log10 copies per milliliter | Standard Deviation 0.667 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 28; n=51, 52, 52, 45 | -2.663 Log10 copies per milliliter | Standard Deviation 0.6356 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 36; n=52, 53, 55, 45 | -2.646 Log10 copies per milliliter | Standard Deviation 0.6786 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 40; n=52, 53, 55, 45 | -2.638 Log10 copies per milliliter | Standard Deviation 0.6581 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 48; n=51, 53, 54, 44 | -2.602 Log10 copies per milliliter | Standard Deviation 0.7855 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 60; n=48, 48, 53, 44 | -2.613 Log10 copies per milliliter | Standard Deviation 0.6068 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 72; n=47, 48, 52, 42 | -2.514 Log10 copies per milliliter | Standard Deviation 0.7487 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 84; n=46, 48, 52, 42 | -2.568 Log10 copies per milliliter | Standard Deviation 0.7144 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 96; n=45, 48, 52, 40 | -2.608 Log10 copies per milliliter | Standard Deviation 0.6342 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 108; n=43, 46, 49, 0 | -2.632 Log10 copies per milliliter | Standard Deviation 0.6265 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 120; n=41, 46, 49, 0 | -2.650 Log10 copies per milliliter | Standard Deviation 0.6137 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 132; n=40, 46, 49, 0 | -2.610 Log10 copies per milliliter | Standard Deviation 0.6718 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 156; n=37, 42, 49, 0 | -2.645 Log10 copies per milliliter | Standard Deviation 0.6129 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 180; n=36, 41, 47, 0 | -2.628 Log10 copies per milliliter | Standard Deviation 0.6251 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 192; n=36, 40, 47, 0 | -2.641 Log10 copies per milliliter | Standard Deviation 0.6272 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 216; n=33, 39, 47, 0 | -2.636 Log10 copies per milliliter | Standard Deviation 0.6337 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 228; n=32, 39, 47, 0 | -2.636 Log10 copies per milliliter | Standard Deviation 0.6346 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 252; n=31, 38, 47, 0 | -2.601 Log10 copies per milliliter | Standard Deviation 0.6209 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 264; n=32, 38, 47, 0 | -2.659 Log10 copies per milliliter | Standard Deviation 0.6264 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 276; n=31, 38, 45, 0 | -2.659 Log10 copies per milliliter | Standard Deviation 0.6264 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 300; n=31, 37, 44, 0 | -2.664 Log10 copies per milliliter | Standard Deviation 0.6344 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 312; n=31, 33, 43, 0 | -2.569 Log10 copies per milliliter | Standard Deviation 0.6037 |
| GSK1265744 30 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 324; n=3, 4, 3, 0 | -2.215 Log10 copies per milliliter | Standard Deviation 0.4624 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 36; n=52, 53, 55, 45 | -2.792 Log10 copies per milliliter | Standard Deviation 0.5803 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 16; n=57, 54, 57, 52 | -2.815 Log10 copies per milliliter | Standard Deviation 0.617 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 312; n=31, 33, 43, 0 | -2.789 Log10 copies per milliliter | Standard Deviation 0.5825 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 240; n=31, 39, 45, 0 | -2.736 Log10 copies per milliliter | Standard Deviation 0.5861 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 40; n=52, 53, 55, 45 | -2.790 Log10 copies per milliliter | Standard Deviation 0.5736 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 12; n=58, 52, 57, 51 | -2.790 Log10 copies per milliliter | Standard Deviation 0.6515 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 26; n=48, 50, 53, 44 | -2.792 Log10 copies per milliliter | Standard Deviation 0.6014 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 168; n=35, 43, 47, 0 | -2.700 Log10 copies per milliliter | Standard Deviation 0.5907 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 48; n=51, 53, 54, 44 | -2.799 Log10 copies per milliliter | Standard Deviation 0.5946 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 276; n=31, 38, 45, 0 | -2.764 Log10 copies per milliliter | Standard Deviation 0.6002 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 132; n=40, 46, 49, 0 | -2.743 Log10 copies per milliliter | Standard Deviation 0.5851 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 144; n=37, 45, 47, 0 | -2.703 Log10 copies per milliliter | Standard Deviation 0.6903 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 60; n=48, 48, 53, 44 | -2.787 Log10 copies per milliliter | Standard Deviation 0.592 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 20; n=56, 54, 56, 47 | -2.834 Log10 copies per milliliter | Standard Deviation 0.625 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 24; n=56, 53, 56, 48 | -2.830 Log10 copies per milliliter | Standard Deviation 0.6304 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 252; n=31, 38, 47, 0 | -2.758 Log10 copies per milliliter | Standard Deviation 0.5875 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 72; n=47, 48, 52, 42 | -2.783 Log10 copies per milliliter | Standard Deviation 0.6009 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 264; n=32, 38, 47, 0 | -2.734 Log10 copies per milliliter | Standard Deviation 0.6213 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 156; n=37, 42, 49, 0 | -2.716 Log10 copies per milliliter | Standard Deviation 0.6309 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 8; n=59, 56, 57, 55 | -2.741 Log10 copies per milliliter | Standard Deviation 0.7034 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 324; n=3, 4, 3, 0 | -2.438 Log10 copies per milliliter | Standard Deviation 0.5904 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 288; n=30, 38, 45, 0 | -2.775 Log10 copies per milliliter | Standard Deviation 0.5984 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 180; n=36, 41, 47, 0 | -2.767 Log10 copies per milliliter | Standard Deviation 0.5672 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 4; n=58, 57, 59, 57 | -2.718 Log10 copies per milliliter | Standard Deviation 0.4981 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 84; n=46, 48, 52, 42 | -2.782 Log10 copies per milliliter | Standard Deviation 0.5994 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 192; n=36, 40, 47, 0 | -2.667 Log10 copies per milliliter | Standard Deviation 0.8708 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 204; n=34, 39, 47, 0 | -2.718 Log10 copies per milliliter | Standard Deviation 0.7294 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 120; n=41, 46, 49, 0 | -2.717 Log10 copies per milliliter | Standard Deviation 0.618 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 96; n=45, 48, 52, 40 | -2.778 Log10 copies per milliliter | Standard Deviation 0.5943 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 216; n=33, 39, 47, 0 | -2.718 Log10 copies per milliliter | Standard Deviation 0.666 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 2; n=57, 56, 59, 59 | -2.504 Log10 copies per milliliter | Standard Deviation 0.4311 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 300; n=31, 37, 44, 0 | -2.730 Log10 copies per milliliter | Standard Deviation 0.6786 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 108; n=43, 46, 49, 0 | -2.743 Log10 copies per milliliter | Standard Deviation 0.5851 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 28; n=51, 52, 52, 45 | -2.791 Log10 copies per milliliter | Standard Deviation 0.5831 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 32; n=52, 53, 55, 45 | -2.781 Log10 copies per milliliter | Standard Deviation 0.6146 |
| GSK1265744 60 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 228; n=32, 39, 47, 0 | -2.726 Log10 copies per milliliter | Standard Deviation 0.6757 |
| Efavirenz 600 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 28; n=51, 52, 52, 45 | -2.714 Log10 copies per milliliter | Standard Deviation 0.6873 |
| Efavirenz 600 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 20; n=56, 54, 56, 47 | -2.666 Log10 copies per milliliter | Standard Deviation 0.6512 |
| Efavirenz 600 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 96; n=45, 48, 52, 40 | -2.731 Log10 copies per milliliter | Standard Deviation 0.6586 |
| Efavirenz 600 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 16; n=57, 54, 57, 52 | -2.602 Log10 copies per milliliter | Standard Deviation 0.6698 |
| Efavirenz 600 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 8; n=59, 56, 57, 55 | -2.344 Log10 copies per milliliter | Standard Deviation 0.6765 |
| Efavirenz 600 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 84; n=46, 48, 52, 42 | -2.739 Log10 copies per milliliter | Standard Deviation 0.6431 |
| Efavirenz 600 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 4; n=58, 57, 59, 57 | -2.092 Log10 copies per milliliter | Standard Deviation 0.4866 |
| Efavirenz 600 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 2; n=57, 56, 59, 59 | -1.875 Log10 copies per milliliter | Standard Deviation 0.4273 |
| Efavirenz 600 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 12; n=58, 52, 57, 51 | -2.533 Log10 copies per milliliter | Standard Deviation 0.658 |
| Efavirenz 600 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 72; n=47, 48, 52, 42 | -2.738 Log10 copies per milliliter | Standard Deviation 0.6415 |
| Efavirenz 600 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 36; n=52, 53, 55, 45 | -2.679 Log10 copies per milliliter | Standard Deviation 0.6776 |
| Efavirenz 600 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 26; n=48, 50, 53, 44 | -2.733 Log10 copies per milliliter | Standard Deviation 0.6879 |
| Efavirenz 600 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 40; n=52, 53, 55, 45 | -2.679 Log10 copies per milliliter | Standard Deviation 0.6817 |
| Efavirenz 600 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 48; n=51, 53, 54, 44 | -2.676 Log10 copies per milliliter | Standard Deviation 0.6773 |
| Efavirenz 600 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 24; n=56, 53, 56, 48 | -2.694 Log10 copies per milliliter | Standard Deviation 0.6843 |
| Efavirenz 600 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 32; n=52, 53, 55, 45 | -2.672 Log10 copies per milliliter | Standard Deviation 0.6812 |
| Efavirenz 600 mg | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit | Week 60; n=48, 48, 53, 44 | -2.615 Log10 copies per milliliter | Standard Deviation 0.8875 |
Secondary
Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit
Blood samples were collected for the analysis of total neutrophils, platelet count and WBC count. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
Time frame: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Population: Safety Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 120; n=41, 46, 49, 0 | 0.59 Giga cells per liter | Standard Deviation 1.931 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 168; n=35, 43, 47, 0 | 0.97 Giga cells per liter | Standard Deviation 1.859 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 300; n=30, 37, 43, 0 | 0.58 Giga cells per liter | Standard Deviation 1.762 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 312; n=31, 33, 41, 0 | 0.57 Giga cells per liter | Standard Deviation 1.732 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 216; n=32, 39, 43, 0 | 0.543 Giga cells per liter | Standard Deviation 1.7307 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 228; n=31, 39, 46, 0 | 28.7 Giga cells per liter | Standard Deviation 49.38 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 240; n=32, 39, 47, 0 | 27.2 Giga cells per liter | Standard Deviation 52.69 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 26; n=48, 50, 53, 45 | 0.120 Giga cells per liter | Standard Deviation 0.8908 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 252; n=31, 36, 44, 0 | 15.9 Giga cells per liter | Standard Deviation 48.02 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 276; n=31, 38, 45, 0 | 48.4 Giga cells per liter | Standard Deviation 55.68 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 228; n=30, 39, 47, 0 | 0.780 Giga cells per liter | Standard Deviation 1.717 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 288; n=30, 38, 43, 0 | 44.1 Giga cells per liter | Standard Deviation 60.21 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 24; n=56, 53, 56, 47 | 0.47 Giga cells per liter | Standard Deviation 1.245 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 12; n=58, 53, 57, 51 | 0.138 Giga cells per liter | Standard Deviation 1.2352 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 26; n=48, 50, 53, 45 | 0.19 Giga cells per liter | Standard Deviation 1.13 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 240; n=32, 39, 47, 0 | 0.508 Giga cells per liter | Standard Deviation 1.4277 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 28; n=50, 52, 52, 45 | 0.67 Giga cells per liter | Standard Deviation 1.412 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 60; n=48, 47, 52, 44 | 0.60 Giga cells per liter | Standard Deviation 1.774 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 84; n=46, 48, 51, 42 | 0.71 Giga cells per liter | Standard Deviation 1.805 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 8; n=58, 56, 56, 55 | 0.251 Giga cells per liter | Standard Deviation 1.0956 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 108; n=43, 46, 49, 0 | 0.89 Giga cells per liter | Standard Deviation 2.19 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 252; n=31, 36, 45, 0 | 0.268 Giga cells per liter | Standard Deviation 1.4164 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 132; n=40, 46, 49, 0 | 0.92 Giga cells per liter | Standard Deviation 2.274 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 28; n=50, 52, 52, 45 | 0.496 Giga cells per liter | Standard Deviation 1.133 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 144; n=37, 45, 46, 0 | 0.91 Giga cells per liter | Standard Deviation 1.667 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 264; n=32, 38, 46, 0 | 0.475 Giga cells per liter | Standard Deviation 1.7483 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 156; n=37, 42, 49, 0 | 1.05 Giga cells per liter | Standard Deviation 2.056 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 180; n=36, 41, 47, 0 | 1.07 Giga cells per liter | Standard Deviation 1.778 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 276; n=31, 38, 45, 0 | 0.400 Giga cells per liter | Standard Deviation 1.6597 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 192; n=35, 40, 47, 0 | 0.61 Giga cells per liter | Standard Deviation 1.645 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 204; n=34, 39, 47, 0 | 0.98 Giga cells per liter | Standard Deviation 2.042 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 216; n=32, 39, 43, 0 | 0.88 Giga cells per liter | Standard Deviation 2.175 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 288; n=30, 38, 44, 0 | 0.456 Giga cells per liter | Standard Deviation 1.8521 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 228; n=31, 39, 47, 0 | 0.98 Giga cells per liter | Standard Deviation 1.97 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 240; n=32, 39, 47, 0 | 0.79 Giga cells per liter | Standard Deviation 1.851 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 168; n=35, 43, 46, 0 | 34.9 Giga cells per liter | Standard Deviation 43.78 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 252; n=31, 36, 45, 0 | 0.66 Giga cells per liter | Standard Deviation 1.649 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 300; n=30, 37, 43, 0 | 0.139 Giga cells per liter | Standard Deviation 1.2243 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 264; n=32, 38, 46, 0 | 0.62 Giga cells per liter | Standard Deviation 1.798 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 276; n=31, 38, 45, 0 | 0.92 Giga cells per liter | Standard Deviation 1.985 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 288; n=30, 38, 44, 0 | 0.92 Giga cells per liter | Standard Deviation 2.188 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 312; n=31, 33, 41, 0 | 0.243 Giga cells per liter | Standard Deviation 1.3595 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 324; n=3, 4, 2, 0 | 1.97 Giga cells per liter | Standard Deviation 3.075 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 40; n=51, 53, 55, 45 | 0.430 Giga cells per liter | Standard Deviation 1.4711 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 324; n=3, 4, 2, 0 | 0.860 Giga cells per liter | Standard Deviation 2.7921 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 2; n=57, 56, 59, 59 | 11.0 Giga cells per liter | Standard Deviation 30.21 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 132; n=40, 46, 48, 0 | 16.8 Giga cells per liter | Standard Deviation 33.67 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 4; n=57, 57, 59, 57 | 9.9 Giga cells per liter | Standard Deviation 27.7 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 8; n=58, 56, 56, 55 | 10.3 Giga cells per liter | Standard Deviation 26.33 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 156; n=37, 42, 47, 0 | 26.6 Giga cells per liter | Standard Deviation 53.14 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 120; n=41, 46, 49, 0 | 23.8 Giga cells per liter | Standard Deviation 48.05 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 12; n=58, 53, 57, 51 | 13.7 Giga cells per liter | Standard Deviation 28.85 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 48; n=51, 53, 54, 44 | 0.386 Giga cells per liter | Standard Deviation 1.3376 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 16; n=57, 54, 57, 52 | 16.5 Giga cells per liter | Standard Deviation 36.43 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 108; n=43, 46, 49, 0 | 24.5 Giga cells per liter | Standard Deviation 44.43 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 20; n=56, 54, 55, 49 | 17.2 Giga cells per liter | Standard Deviation 32.75 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 24; n=56, 53, 56, 47 | 12.0 Giga cells per liter | Standard Deviation 31.51 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 96; n=46, 45, 51, 41 | 25.9 Giga cells per liter | Standard Deviation 39.73 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 26; n=48, 50, 53, 45 | 8.3 Giga cells per liter | Standard Deviation 32.59 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 60; n=48, 47, 52, 44 | 0.374 Giga cells per liter | Standard Deviation 1.4938 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 28; n=50, 52, 52, 45 | 6.6 Giga cells per liter | Standard Deviation 33 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 32; n=51, 52, 55, 45 | 7.7 Giga cells per liter | Standard Deviation 41.79 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 20; n=56, 54, 55, 49 | 0.270 Giga cells per liter | Standard Deviation 1.3671 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 84; n=46, 48, 51, 42 | 13.6 Giga cells per liter | Standard Deviation 42.78 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 36; n=52, 53, 55, 44 | 5.2 Giga cells per liter | Standard Deviation 39.32 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 144; n=37, 45, 44, 0 | 27.1 Giga cells per liter | Standard Deviation 50.68 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 40; n=51, 53, 54, 45 | 11.1 Giga cells per liter | Standard Deviation 44.07 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 72; n=47, 48, 52, 42 | 0.383 Giga cells per liter | Standard Deviation 1.6125 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 72; n=47, 48, 52, 42 | 23.7 Giga cells per liter | Standard Deviation 37.03 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 48; n=51, 52, 53, 44 | 12.5 Giga cells per liter | Standard Deviation 41.82 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 60; n=48, 47, 51, 44 | 20.9 Giga cells per liter | Standard Deviation 39.25 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 180; n=36, 41, 46, 0 | 28.4 Giga cells per liter | Standard Deviation 48.03 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 84; n=46, 48, 51, 42 | 0.410 Giga cells per liter | Standard Deviation 1.6209 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 192; n=35, 40, 46, 0 | 34.7 Giga cells per liter | Standard Deviation 58.72 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 108; n=43, 46, 49, 0 | 0.623 Giga cells per liter | Standard Deviation 1.7946 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 204; n=34, 39, 45, 0 | 33.9 Giga cells per liter | Standard Deviation 59.13 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 264; n=32, 38, 45, 0 | 27.9 Giga cells per liter | Standard Deviation 48.97 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 300; n=30, 37, 40, 0 | 28.5 Giga cells per liter | Standard Deviation 55.51 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 120; n=41, 46, 49, 0 | 0.372 Giga cells per liter | Standard Deviation 1.759 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 312; n=31, 33, 41, 0 | 27.3 Giga cells per liter | Standard Deviation 52.62 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 324; n=3, 4, 2, 0 | 31.7 Giga cells per liter | Standard Deviation 17.47 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 2; n=57, 56, 59, 59 | 0.042 Giga cells per liter | Standard Deviation 1.0528 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 2; n=57, 56, 59, 59 | 0.19 Giga cells per liter | Standard Deviation 1.176 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 132; n=40, 46, 49, 0 | 0.777 Giga cells per liter | Standard Deviation 2.1995 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 4; n=57, 57, 59, 57 | 0.16 Giga cells per liter | Standard Deviation 1.493 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 8; n=58, 56, 56, 55 | 0.37 Giga cells per liter | Standard Deviation 1.298 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 216; n=32, 39, 44, 0 | 28.1 Giga cells per liter | Standard Deviation 48.97 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 180; n=36, 41, 47, 0 | 0.769 Giga cells per liter | Standard Deviation 1.4717 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC; Week 12; n=58, 53, 57, 51 | 0.32 Giga cells per liter | Standard Deviation 1.427 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 144; n=37, 45, 46, 0 | 0.672 Giga cells per liter | Standard Deviation 1.3974 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 16; n=57, 54, 57, 52 | 0.45 Giga cells per liter | Standard Deviation 1.806 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 168; n=35, 43, 47, 0 | 0.588 Giga cells per liter | Standard Deviation 1.5738 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 20; n=56, 54, 55, 49 | 0.36 Giga cells per liter | Standard Deviation 1.51 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 24; n=56, 53, 56, 47 | 0.462 Giga cells per liter | Standard Deviation 1.1725 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 156; n=37, 42, 49, 0 | 0.762 Giga cells per liter | Standard Deviation 1.7331 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 96; n=46, 46, 52, 41 | 0.631 Giga cells per liter | Standard Deviation 1.3478 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 32; n=51, 53, 55, 45 | 0.25 Giga cells per liter | Standard Deviation 1.598 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 36; n=52, 53, 55, 44 | 0.56 Giga cells per liter | Standard Deviation 1.532 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 40; n=51, 53, 55, 45 | 0.57 Giga cells per liter | Standard Deviation 1.668 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 192; n=35, 40, 47, 0 | 0.490 Giga cells per liter | Standard Deviation 1.3807 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 36; n=52, 53, 55, 44 | 0.420 Giga cells per liter | Standard Deviation 1.4246 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 48; n=51, 53, 54, 44 | 0.43 Giga cells per liter | Standard Deviation 1.499 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 4; n=57, 57, 59, 57 | 0.038 Giga cells per liter | Standard Deviation 1.2691 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 32; n=51, 53, 55, 45 | 0.071 Giga cells per liter | Standard Deviation 1.3373 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 72; n=47, 48, 52, 42 | 0.63 Giga cells per liter | Standard Deviation 1.932 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 204; n=34, 39, 47, 0 | 0.618 Giga cells per liter | Standard Deviation 1.7745 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 16; n=57, 54, 57, 52 | 0.388 Giga cells per liter | Standard Deviation 1.7066 |
| GSK1265744 10 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 96; n=46, 46, 52, 41 | 0.95 Giga cells per liter | Standard Deviation 1.687 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 32; n=51, 53, 55, 45 | 0.45 Giga cells per liter | Standard Deviation 1.767 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 2; n=57, 56, 59, 59 | 0.13 Giga cells per liter | Standard Deviation 1.506 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 168; n=35, 43, 47, 0 | 0.97 Giga cells per liter | Standard Deviation 1.748 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 276; n=31, 38, 45, 0 | 1.04 Giga cells per liter | Standard Deviation 2.056 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 204; n=34, 39, 47, 0 | 0.648 Giga cells per liter | Standard Deviation 1.7939 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 20; n=56, 54, 55, 49 | 14.5 Giga cells per liter | Standard Deviation 29.72 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 300; n=30, 37, 43, 0 | 0.77 Giga cells per liter | Standard Deviation 1.856 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 204; n=34, 39, 45, 0 | 26.4 Giga cells per liter | Standard Deviation 31.26 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 216; n=32, 39, 44, 0 | 25.2 Giga cells per liter | Standard Deviation 31.6 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 96; n=46, 45, 51, 41 | 20.8 Giga cells per liter | Standard Deviation 39 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 156; n=37, 42, 49, 0 | 0.418 Giga cells per liter | Standard Deviation 1.6395 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 228; n=31, 39, 46, 0 | 27.1 Giga cells per liter | Standard Deviation 35.77 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 216; n=32, 39, 43, 0 | 0.588 Giga cells per liter | Standard Deviation 1.5854 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 24; n=56, 53, 56, 47 | 18.4 Giga cells per liter | Standard Deviation 34.3 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 240; n=32, 39, 47, 0 | 26.2 Giga cells per liter | Standard Deviation 31.38 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 144; n=37, 45, 44, 0 | 23.2 Giga cells per liter | Standard Deviation 31.97 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 2; n=57, 56, 59, 59 | 16.6 Giga cells per liter | Standard Deviation 27.48 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 252; n=31, 36, 44, 0 | 15.4 Giga cells per liter | Standard Deviation 31.97 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 84; n=46, 48, 51, 42 | 0.528 Giga cells per liter | Standard Deviation 1.6303 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 276; n=31, 38, 45, 0 | 34.5 Giga cells per liter | Standard Deviation 34.41 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 26; n=48, 50, 53, 45 | 11.2 Giga cells per liter | Standard Deviation 36.32 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 4; n=57, 57, 59, 57 | 0.02 Giga cells per liter | Standard Deviation 1.435 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 288; n=30, 38, 43, 0 | 35.5 Giga cells per liter | Standard Deviation 34.89 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 228; n=30, 39, 47, 0 | 0.789 Giga cells per liter | Standard Deviation 1.6779 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 132; n=40, 46, 49, 0 | 0.405 Giga cells per liter | Standard Deviation 1.6979 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 24; n=56, 53, 56, 47 | 0.34 Giga cells per liter | Standard Deviation 2.06 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 26; n=48, 50, 53, 45 | 0.052 Giga cells per liter | Standard Deviation 1.7443 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 28; n=50, 52, 52, 45 | 15.8 Giga cells per liter | Standard Deviation 34.97 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 60; n=48, 47, 52, 44 | 0.458 Giga cells per liter | Standard Deviation 1.6323 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 26; n=48, 50, 53, 45 | 0.26 Giga cells per liter | Standard Deviation 2.039 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 84; n=46, 48, 51, 42 | 17.2 Giga cells per liter | Standard Deviation 32 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 8; n=58, 56, 56, 55 | -0.066 Giga cells per liter | Standard Deviation 1.3186 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 180; n=36, 41, 47, 0 | 0.405 Giga cells per liter | Standard Deviation 1.7183 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 32; n=51, 52, 55, 45 | 11.6 Giga cells per liter | Standard Deviation 36.27 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 60; n=48, 47, 52, 44 | 0.76 Giga cells per liter | Standard Deviation 1.686 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 84; n=46, 48, 51, 42 | 0.96 Giga cells per liter | Standard Deviation 1.914 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 240; n=32, 39, 47, 0 | 0.813 Giga cells per liter | Standard Deviation 1.7505 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 168; n=35, 43, 46, 0 | 36.4 Giga cells per liter | Standard Deviation 37.72 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 8; n=58, 56, 56, 55 | 0.15 Giga cells per liter | Standard Deviation 1.595 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 36; n=52, 53, 55, 44 | 0.30 Giga cells per liter | Standard Deviation 2.068 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 108; n=43, 46, 49, 0 | 0.90 Giga cells per liter | Standard Deviation 1.714 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 36; n=52, 53, 55, 44 | 10.8 Giga cells per liter | Standard Deviation 39.28 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 252; n=31, 36, 45, 0 | 0.761 Giga cells per liter | Standard Deviation 1.5531 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 24; n=56, 53, 56, 47 | 0.109 Giga cells per liter | Standard Deviation 1.7578 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 132; n=40, 46, 49, 0 | 0.71 Giga cells per liter | Standard Deviation 1.958 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 72; n=47, 48, 52, 42 | 22.8 Giga cells per liter | Standard Deviation 32.35 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 36; n=52, 53, 55, 44 | 0.029 Giga cells per liter | Standard Deviation 1.7516 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 144; n=37, 45, 46, 0 | 0.82 Giga cells per liter | Standard Deviation 1.727 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 40; n=51, 53, 54, 45 | 8.9 Giga cells per liter | Standard Deviation 31.95 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC; Week 12; n=58, 53, 57, 51 | 0.28 Giga cells per liter | Standard Deviation 1.696 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 156; n=37, 42, 49, 0 | 0.75 Giga cells per liter | Standard Deviation 1.797 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 264; n=32, 38, 46, 0 | 0.761 Giga cells per liter | Standard Deviation 1.7316 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 28; n=50, 52, 52, 45 | 0.213 Giga cells per liter | Standard Deviation 1.4523 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 120; n=41, 46, 49, 0 | 1.01 Giga cells per liter | Standard Deviation 1.988 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 180; n=36, 41, 47, 0 | 0.69 Giga cells per liter | Standard Deviation 1.902 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 168; n=35, 43, 47, 0 | 0.534 Giga cells per liter | Standard Deviation 1.671 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 48; n=51, 52, 53, 44 | 20.0 Giga cells per liter | Standard Deviation 38.2 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 192; n=35, 40, 47, 0 | 0.89 Giga cells per liter | Standard Deviation 1.972 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 276; n=31, 38, 45, 0 | 0.627 Giga cells per liter | Standard Deviation 1.85 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 72; n=47, 48, 52, 42 | 0.274 Giga cells per liter | Standard Deviation 1.5663 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 204; n=34, 39, 47, 0 | 0.95 Giga cells per liter | Standard Deviation 1.823 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 16; n=57, 54, 57, 52 | -0.156 Giga cells per liter | Standard Deviation 1.2694 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 60; n=48, 47, 51, 44 | 18.7 Giga cells per liter | Standard Deviation 34.22 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 216; n=32, 39, 43, 0 | 1.01 Giga cells per liter | Standard Deviation 1.859 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 132; n=40, 46, 48, 0 | 21.0 Giga cells per liter | Standard Deviation 35.98 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 40; n=51, 53, 55, 45 | 0.42 Giga cells per liter | Standard Deviation 1.654 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 228; n=31, 39, 47, 0 | 1.13 Giga cells per liter | Standard Deviation 1.918 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 288; n=30, 38, 44, 0 | 0.673 Giga cells per liter | Standard Deviation 1.923 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 16; n=57, 54, 57, 52 | 0.02 Giga cells per liter | Standard Deviation 1.554 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 240; n=32, 39, 47, 0 | 1.15 Giga cells per liter | Standard Deviation 1.942 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 180; n=36, 41, 46, 0 | 27.6 Giga cells per liter | Standard Deviation 36.53 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 144; n=37, 45, 46, 0 | 0.468 Giga cells per liter | Standard Deviation 1.621 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 252; n=31, 36, 45, 0 | 1.10 Giga cells per liter | Standard Deviation 1.814 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 96; n=46, 46, 52, 41 | 1.01 Giga cells per liter | Standard Deviation 2.069 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 192; n=35, 40, 46, 0 | 24.6 Giga cells per liter | Standard Deviation 37.42 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 264; n=32, 38, 46, 0 | 1.21 Giga cells per liter | Standard Deviation 1.985 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 300; n=30, 37, 43, 0 | 0.455 Giga cells per liter | Standard Deviation 1.4957 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 12; n=58, 53, 57, 51 | 0.040 Giga cells per liter | Standard Deviation 1.4855 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 20; n=56, 54, 55, 49 | 0.23 Giga cells per liter | Standard Deviation 1.523 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 288; n=30, 38, 44, 0 | 1.13 Giga cells per liter | Standard Deviation 2.293 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 156; n=37, 42, 47, 0 | 30.6 Giga cells per liter | Standard Deviation 37.65 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 312; n=31, 33, 41, 0 | 0.70 Giga cells per liter | Standard Deviation 2.051 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 108; n=43, 46, 49, 0 | 0.570 Giga cells per liter | Standard Deviation 1.5706 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 72; n=47, 48, 52, 42 | 0.56 Giga cells per liter | Standard Deviation 1.917 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 324; n=3, 4, 2, 0 | 0.53 Giga cells per liter | Standard Deviation 0.984 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 4; n=57, 57, 59, 57 | -0.083 Giga cells per liter | Standard Deviation 1.2859 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 312; n=31, 33, 41, 0 | 0.417 Giga cells per liter | Standard Deviation 1.7807 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 264; n=32, 38, 45, 0 | 23.2 Giga cells per liter | Standard Deviation 29.82 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 20; n=56, 54, 55, 49 | 0.032 Giga cells per liter | Standard Deviation 1.3837 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 324; n=3, 4, 2, 0 | 0.315 Giga cells per liter | Standard Deviation 1.066 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 40; n=51, 53, 55, 45 | 0.178 Giga cells per liter | Standard Deviation 1.3099 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 96; n=46, 46, 52, 41 | 0.698 Giga cells per liter | Standard Deviation 1.8981 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 300; n=30, 37, 40, 0 | 26.8 Giga cells per liter | Standard Deviation 36.02 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 28; n=50, 52, 52, 45 | 0.42 Giga cells per liter | Standard Deviation 1.685 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 4; n=57, 57, 59, 57 | 20.1 Giga cells per liter | Standard Deviation 30.52 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 2; n=57, 56, 59, 59 | -0.084 Giga cells per liter | Standard Deviation 1.4018 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 120; n=41, 46, 49, 0 | 26.9 Giga cells per liter | Standard Deviation 33.58 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 48; n=51, 53, 54, 44 | 0.53 Giga cells per liter | Standard Deviation 1.912 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 8; n=58, 56, 56, 55 | 25.9 Giga cells per liter | Standard Deviation 33.21 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 312; n=31, 33, 41, 0 | 30.9 Giga cells per liter | Standard Deviation 34.28 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 120; n=41, 46, 49, 0 | 0.650 Giga cells per liter | Standard Deviation 1.8334 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 192; n=35, 40, 47, 0 | 0.594 Giga cells per liter | Standard Deviation 1.7286 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 12; n=58, 53, 57, 51 | 14.6 Giga cells per liter | Standard Deviation 35 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 324; n=3, 4, 2, 0 | 8.3 Giga cells per liter | Standard Deviation 7.46 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 108; n=43, 46, 49, 0 | 24.6 Giga cells per liter | Standard Deviation 30.23 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 32; n=51, 53, 55, 45 | 0.149 Giga cells per liter | Standard Deviation 1.5137 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 16; n=57, 54, 57, 52 | 11.3 Giga cells per liter | Standard Deviation 30.85 |
| GSK1265744 30 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 48; n=51, 53, 54, 44 | 0.245 Giga cells per liter | Standard Deviation 1.5695 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 216; n=32, 39, 44, 0 | 33.5 Giga cells per liter | Standard Deviation 44.09 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 2; n=57, 56, 59, 59 | 0.104 Giga cells per liter | Standard Deviation 1.0318 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 16; n=57, 54, 57, 52 | 0.203 Giga cells per liter | Standard Deviation 1.0459 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 20; n=56, 54, 55, 49 | 0.525 Giga cells per liter | Standard Deviation 1.6689 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 24; n=56, 53, 56, 47 | 0.406 Giga cells per liter | Standard Deviation 1.0404 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 28; n=50, 52, 52, 45 | 0.502 Giga cells per liter | Standard Deviation 1.2817 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 40; n=51, 53, 55, 45 | 0.575 Giga cells per liter | Standard Deviation 1.051 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 48; n=51, 53, 54, 44 | 0.534 Giga cells per liter | Standard Deviation 1.3432 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 60; n=48, 47, 52, 44 | 0.711 Giga cells per liter | Standard Deviation 0.9216 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 108; n=43, 46, 49, 0 | 1.006 Giga cells per liter | Standard Deviation 1.6122 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 120; n=41, 46, 49, 0 | 0.769 Giga cells per liter | Standard Deviation 1.6486 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 132; n=40, 46, 49, 0 | 0.671 Giga cells per liter | Standard Deviation 1.0761 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 144; n=37, 45, 46, 0 | 0.831 Giga cells per liter | Standard Deviation 1.4397 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 156; n=37, 42, 49, 0 | 1.095 Giga cells per liter | Standard Deviation 1.2219 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 192; n=35, 40, 47, 0 | 0.722 Giga cells per liter | Standard Deviation 1.2591 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 204; n=34, 39, 47, 0 | 0.821 Giga cells per liter | Standard Deviation 1.4259 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 216; n=32, 39, 43, 0 | 0.914 Giga cells per liter | Standard Deviation 1.447 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 228; n=30, 39, 47, 0 | 0.819 Giga cells per liter | Standard Deviation 1.1182 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 240; n=32, 39, 47, 0 | 1.083 Giga cells per liter | Standard Deviation 2.3145 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 252; n=31, 36, 45, 0 | 0.812 Giga cells per liter | Standard Deviation 1.3345 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 264; n=32, 38, 46, 0 | 1.176 Giga cells per liter | Standard Deviation 1.6844 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 276; n=31, 38, 45, 0 | 1.106 Giga cells per liter | Standard Deviation 1.3666 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 288; n=30, 38, 44, 0 | 0.913 Giga cells per liter | Standard Deviation 1.588 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 300; n=30, 37, 43, 0 | 0.699 Giga cells per liter | Standard Deviation 1.103 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 312; n=31, 33, 41, 0 | 0.564 Giga cells per liter | Standard Deviation 1.1666 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 324; n=3, 4, 2, 0 | 0.960 Giga cells per liter | Standard Deviation 0.495 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 4; n=57, 57, 59, 57 | 14.1 Giga cells per liter | Standard Deviation 21.35 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 8; n=58, 56, 56, 55 | 18.4 Giga cells per liter | Standard Deviation 27.51 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 12; n=58, 53, 57, 51 | 17.7 Giga cells per liter | Standard Deviation 33.02 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 16; n=57, 54, 57, 52 | 17.9 Giga cells per liter | Standard Deviation 34.32 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 20; n=56, 54, 55, 49 | 13.7 Giga cells per liter | Standard Deviation 32.98 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 24; n=56, 53, 56, 47 | 19.3 Giga cells per liter | Standard Deviation 27.64 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 26; n=48, 50, 53, 45 | 10.3 Giga cells per liter | Standard Deviation 30.94 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 28; n=50, 52, 52, 45 | 17.8 Giga cells per liter | Standard Deviation 27.83 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 32; n=51, 52, 55, 45 | 15.4 Giga cells per liter | Standard Deviation 27.19 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 36; n=52, 53, 55, 44 | 11.8 Giga cells per liter | Standard Deviation 32.72 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 40; n=51, 53, 54, 45 | 7.8 Giga cells per liter | Standard Deviation 31.86 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 48; n=51, 52, 53, 44 | 17.6 Giga cells per liter | Standard Deviation 38.7 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 84; n=46, 48, 51, 42 | 21.1 Giga cells per liter | Standard Deviation 38.36 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 180; n=36, 41, 46, 0 | 45.4 Giga cells per liter | Standard Deviation 54.46 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 192; n=35, 40, 46, 0 | 27.9 Giga cells per liter | Standard Deviation 45.02 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 252; n=31, 36, 44, 0 | 30.8 Giga cells per liter | Standard Deviation 39.37 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 264; n=32, 38, 45, 0 | 32.8 Giga cells per liter | Standard Deviation 43.26 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 300; n=30, 37, 40, 0 | 45.4 Giga cells per liter | Standard Deviation 39.15 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 312; n=31, 33, 41, 0 | 35.3 Giga cells per liter | Standard Deviation 37.26 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 324; n=3, 4, 2, 0 | 2.0 Giga cells per liter | Standard Deviation 9.9 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 2; n=57, 56, 59, 59 | 0.31 Giga cells per liter | Standard Deviation 1.314 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 4; n=57, 57, 59, 57 | 0.30 Giga cells per liter | Standard Deviation 1.263 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 8; n=58, 56, 56, 55 | 0.48 Giga cells per liter | Standard Deviation 1.283 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC; Week 12; n=58, 53, 57, 51 | 0.73 Giga cells per liter | Standard Deviation 1.375 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 16; n=57, 54, 57, 52 | 0.36 Giga cells per liter | Standard Deviation 1.08 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 20; n=56, 54, 55, 49 | 0.77 Giga cells per liter | Standard Deviation 1.848 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 28; n=50, 52, 52, 45 | 0.69 Giga cells per liter | Standard Deviation 1.428 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 32; n=51, 53, 55, 45 | 0.93 Giga cells per liter | Standard Deviation 1.704 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 36; n=52, 53, 55, 44 | 0.92 Giga cells per liter | Standard Deviation 1.178 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 40; n=51, 53, 55, 45 | 0.81 Giga cells per liter | Standard Deviation 1.205 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 48; n=51, 53, 54, 44 | 0.78 Giga cells per liter | Standard Deviation 1.447 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 60; n=48, 47, 52, 44 | 1.04 Giga cells per liter | Standard Deviation 1.16 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 72; n=47, 48, 52, 42 | 1.09 Giga cells per liter | Standard Deviation 1.378 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 276; n=31, 38, 45, 0 | 1.57 Giga cells per liter | Standard Deviation 1.721 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 300; n=30, 37, 43, 0 | 1.02 Giga cells per liter | Standard Deviation 1.321 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 324; n=3, 4, 2, 0 | -0.05 Giga cells per liter | Standard Deviation 1.626 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 228; n=31, 39, 46, 0 | 29.1 Giga cells per liter | Standard Deviation 41.22 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 240; n=32, 39, 47, 0 | 27.4 Giga cells per liter | Standard Deviation 42.22 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 276; n=31, 38, 45, 0 | 45.8 Giga cells per liter | Standard Deviation 41.35 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 288; n=30, 38, 43, 0 | 46.7 Giga cells per liter | Standard Deviation 43.13 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 24; n=56, 53, 56, 47 | 0.64 Giga cells per liter | Standard Deviation 1.226 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 26; n=48, 50, 53, 45 | 0.66 Giga cells per liter | Standard Deviation 1.257 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 84; n=46, 48, 51, 42 | 1.43 Giga cells per liter | Standard Deviation 1.622 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 96; n=46, 46, 52, 41 | 1.38 Giga cells per liter | Standard Deviation 1.405 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 108; n=43, 46, 49, 0 | 1.35 Giga cells per liter | Standard Deviation 1.749 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 120; n=41, 46, 49, 0 | 1.16 Giga cells per liter | Standard Deviation 1.632 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 132; n=40, 46, 49, 0 | 1.02 Giga cells per liter | Standard Deviation 1.103 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 144; n=37, 45, 46, 0 | 1.22 Giga cells per liter | Standard Deviation 1.785 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 156; n=37, 42, 49, 0 | 1.64 Giga cells per liter | Standard Deviation 1.291 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 168; n=35, 43, 47, 0 | 1.58 Giga cells per liter | Standard Deviation 1.472 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 180; n=36, 41, 47, 0 | 1.33 Giga cells per liter | Standard Deviation 1.485 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 192; n=35, 40, 47, 0 | 1.11 Giga cells per liter | Standard Deviation 1.428 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 204; n=34, 39, 47, 0 | 1.24 Giga cells per liter | Standard Deviation 1.554 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 216; n=32, 39, 43, 0 | 1.37 Giga cells per liter | Standard Deviation 1.656 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 228; n=31, 39, 47, 0 | 1.31 Giga cells per liter | Standard Deviation 1.329 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 240; n=32, 39, 47, 0 | 1.53 Giga cells per liter | Standard Deviation 2.455 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 252; n=31, 36, 45, 0 | 1.17 Giga cells per liter | Standard Deviation 1.531 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 264; n=32, 38, 46, 0 | 1.66 Giga cells per liter | Standard Deviation 2.03 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 288; n=30, 38, 44, 0 | 1.32 Giga cells per liter | Standard Deviation 1.908 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 312; n=31, 33, 41, 0 | 0.95 Giga cells per liter | Standard Deviation 1.274 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 4; n=57, 57, 59, 57 | 0.155 Giga cells per liter | Standard Deviation 1.0877 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 8; n=58, 56, 56, 55 | 0.341 Giga cells per liter | Standard Deviation 1.2077 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 12; n=58, 53, 57, 51 | 0.359 Giga cells per liter | Standard Deviation 1.3585 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 26; n=48, 50, 53, 45 | 0.375 Giga cells per liter | Standard Deviation 1.1565 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 32; n=51, 53, 55, 45 | 0.692 Giga cells per liter | Standard Deviation 1.4994 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 36; n=52, 53, 55, 44 | 0.535 Giga cells per liter | Standard Deviation 1.0695 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 72; n=47, 48, 52, 42 | 0.666 Giga cells per liter | Standard Deviation 1.2125 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 84; n=46, 48, 51, 42 | 1.006 Giga cells per liter | Standard Deviation 1.4287 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 96; n=46, 46, 52, 41 | 0.997 Giga cells per liter | Standard Deviation 1.3089 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 168; n=35, 43, 47, 0 | 1.011 Giga cells per liter | Standard Deviation 1.2304 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 180; n=36, 41, 47, 0 | 0.840 Giga cells per liter | Standard Deviation 1.0957 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 2; n=57, 56, 59, 59 | 14.3 Giga cells per liter | Standard Deviation 22.17 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 60; n=48, 47, 51, 44 | 26.6 Giga cells per liter | Standard Deviation 37.23 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 72; n=47, 48, 52, 42 | 22.7 Giga cells per liter | Standard Deviation 35.13 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 96; n=46, 45, 51, 41 | 21.7 Giga cells per liter | Standard Deviation 36.57 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 108; n=43, 46, 49, 0 | 33.1 Giga cells per liter | Standard Deviation 46.23 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 120; n=41, 46, 49, 0 | 20.4 Giga cells per liter | Standard Deviation 31.47 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 132; n=40, 46, 48, 0 | 32.2 Giga cells per liter | Standard Deviation 35.34 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 144; n=37, 45, 44, 0 | 33.5 Giga cells per liter | Standard Deviation 54.61 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 156; n=37, 42, 47, 0 | 41.2 Giga cells per liter | Standard Deviation 47.37 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 168; n=35, 43, 46, 0 | 40.0 Giga cells per liter | Standard Deviation 50.19 |
| GSK1265744 60 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 204; n=34, 39, 45, 0 | 37.6 Giga cells per liter | Standard Deviation 45.21 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 84; n=46, 48, 51, 42 | 0.790 Giga cells per liter | Standard Deviation 1.7937 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 28; n=50, 52, 52, 45 | 0.39 Giga cells per liter | Standard Deviation 1.416 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 20; n=56, 54, 55, 49 | 0.78 Giga cells per liter | Standard Deviation 1.821 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 60; n=48, 47, 52, 44 | 0.800 Giga cells per liter | Standard Deviation 1.4058 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 96; n=46, 46, 52, 41 | 0.831 Giga cells per liter | Standard Deviation 1.4347 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 16; n=57, 54, 57, 52 | 0.36 Giga cells per liter | Standard Deviation 1.542 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC; Week 12; n=58, 53, 57, 51 | 0.54 Giga cells per liter | Standard Deviation 1.734 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 48; n=51, 53, 54, 44 | 0.665 Giga cells per liter | Standard Deviation 1.6752 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 8; n=58, 56, 56, 55 | 0.27 Giga cells per liter | Standard Deviation 1.123 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 4; n=57, 57, 59, 57 | 0.29 Giga cells per liter | Standard Deviation 1.753 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 2; n=57, 56, 59, 59 | 0.716 Giga cells per liter | Standard Deviation 1.4565 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 2; n=57, 56, 59, 59 | 0.69 Giga cells per liter | Standard Deviation 1.606 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 40; n=51, 53, 55, 45 | 0.730 Giga cells per liter | Standard Deviation 1.4181 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 26; n=48, 50, 53, 45 | 17.5 Giga cells per liter | Standard Deviation 40.38 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 84; n=46, 48, 51, 42 | 18.9 Giga cells per liter | Standard Deviation 44.07 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 48; n=51, 52, 53, 44 | 20.6 Giga cells per liter | Standard Deviation 42.78 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 36; n=52, 53, 55, 44 | 0.414 Giga cells per liter | Standard Deviation 1.3998 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 60; n=48, 47, 51, 44 | 30.8 Giga cells per liter | Standard Deviation 43.09 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 40; n=51, 53, 54, 45 | 18.9 Giga cells per liter | Standard Deviation 36.94 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 36; n=52, 53, 55, 44 | 12.3 Giga cells per liter | Standard Deviation 43.83 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 20; n=56, 54, 55, 49 | 0.740 Giga cells per liter | Standard Deviation 1.7181 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 72; n=47, 48, 52, 42 | 28.3 Giga cells per liter | Standard Deviation 37.19 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 32; n=51, 52, 55, 45 | 13.8 Giga cells per liter | Standard Deviation 38.26 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 28; n=50, 52, 52, 45 | 17.2 Giga cells per liter | Standard Deviation 44.39 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 24; n=56, 53, 56, 47 | 23.9 Giga cells per liter | Standard Deviation 49.14 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 20; n=56, 54, 55, 49 | 17.1 Giga cells per liter | Standard Deviation 43.06 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 28; n=50, 52, 52, 45 | 0.446 Giga cells per liter | Standard Deviation 1.1851 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 96; n=46, 45, 51, 41 | 17.5 Giga cells per liter | Standard Deviation 40.11 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 16; n=57, 54, 57, 52 | 9.3 Giga cells per liter | Standard Deviation 40.36 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 12; n=58, 53, 57, 51 | 11.2 Giga cells per liter | Standard Deviation 43.26 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 4; n=57, 57, 59, 57 | 0.375 Giga cells per liter | Standard Deviation 1.5303 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 96; n=46, 46, 52, 41 | 0.92 Giga cells per liter | Standard Deviation 1.624 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 26; n=48, 50, 53, 45 | 0.35 Giga cells per liter | Standard Deviation 1.578 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 26; n=48, 50, 53, 45 | 0.449 Giga cells per liter | Standard Deviation 1.3271 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 8; n=58, 56, 56, 55 | 0.273 Giga cells per liter | Standard Deviation 0.8715 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 24; n=56, 53, 56, 47 | 0.55 Giga cells per liter | Standard Deviation 1.822 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 84; n=46, 48, 51, 42 | 0.95 Giga cells per liter | Standard Deviation 1.893 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 8; n=58, 56, 56, 55 | 10.3 Giga cells per liter | Standard Deviation 36.86 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 12; n=58, 53, 57, 51 | 0.525 Giga cells per liter | Standard Deviation 1.5661 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 72; n=47, 48, 52, 42 | 1.02 Giga cells per liter | Standard Deviation 2.28 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 4; n=57, 57, 59, 57 | 15.6 Giga cells per liter | Standard Deviation 38.98 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 60; n=48, 47, 52, 44 | 0.95 Giga cells per liter | Standard Deviation 1.735 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 48; n=51, 53, 54, 44 | 0.73 Giga cells per liter | Standard Deviation 1.874 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 16; n=57, 54, 57, 52 | 0.367 Giga cells per liter | Standard Deviation 1.2022 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 32; n=51, 53, 55, 45 | 0.717 Giga cells per liter | Standard Deviation 1.5595 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 40; n=51, 53, 55, 45 | 0.75 Giga cells per liter | Standard Deviation 1.68 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 36; n=52, 53, 55, 44 | 0.36 Giga cells per liter | Standard Deviation 1.547 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | Platelet count; Week 2; n=57, 56, 59, 59 | 17.1 Giga cells per liter | Standard Deviation 33.56 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 72; n=47, 48, 52, 42 | 0.892 Giga cells per liter | Standard Deviation 1.9492 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | WBC count; Week 32; n=51, 53, 55, 45 | 0.71 Giga cells per liter | Standard Deviation 1.82 |
| Efavirenz 600 mg | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit | T. neutrophils; Week 24; n=56, 53, 56, 47 | 0.637 Giga cells per liter | Standard Deviation 1.5583 |
Secondary
Cmax for Rilpivirine
Data was not collected for analysis of rilpivirine PK parameters.
Time frame: pre-dose and 2 to 4 hours post-dose at Weeks 26 and 36
Population: PK Summary Population. Data were not collected for rilpivirine PK parameters since this drug has been approved already for treatment and the PK of the drug has been well characterized
Secondary
Concentration at the End of a Dosing Interval (Ctau) for GSK1265744 at Week 2
Blood samples for PK analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: pre-dose, 1, 2, 3, 4, 8 and 24 hours post dose at Week 2
Population: PK Summary Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| GSK1265744 10 mg | Concentration at the End of a Dosing Interval (Ctau) for GSK1265744 at Week 2 | 1.45 Micrograms per milliliter | Geometric Coefficient of Variation 37 |
| GSK1265744 30 mg | Concentration at the End of a Dosing Interval (Ctau) for GSK1265744 at Week 2 | 4.34 Micrograms per milliliter | Geometric Coefficient of Variation 38 |
| GSK1265744 60 mg | Concentration at the End of a Dosing Interval (Ctau) for GSK1265744 at Week 2 | 5.83 Micrograms per milliliter | Geometric Coefficient of Variation 61 |
Secondary
Ctau for Rilpivirine
Data was not collected for analysis of rilpivirine PK parameters.
Time frame: pre-dose and 2 to 4 hours post-dose at Weeks 26 and 36
Population: PK Summary Population. Data were not collected for rilpivirine PK parameters since this drug has been approved already for treatment and the PK of the drug has been well characterized
Secondary
Maximum Observed Concentration (Cmax) for GSK1265744 at Week 2
Blood samples for PK analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: pre-dose, 1, 2, 3, 4, 8 and 24 hours post-dose at Week 2
Population: PK Summary Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| GSK1265744 10 mg | Maximum Observed Concentration (Cmax) for GSK1265744 at Week 2 | 2.77 Micrograms per milliliter | Geometric Coefficient of Variation 33 |
| GSK1265744 30 mg | Maximum Observed Concentration (Cmax) for GSK1265744 at Week 2 | 7.49 Micrograms per milliliter | Geometric Coefficient of Variation 28 |
| GSK1265744 60 mg | Maximum Observed Concentration (Cmax) for GSK1265744 at Week 2 | 13.12 Micrograms per milliliter | Geometric Coefficient of Variation 44 |
Secondary
Number of Participants With Adherence to Study Treatment
Number of participants with \>=90% adherence to study treatment based on pill count is summarized.
Time frame: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312
Population: ITT-E Population. Only participants who were dispensed and returned drug on scheduled visits were included in the analysis (represented by n=X in category titles)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1265744 10 mg | Number of Participants With Adherence to Study Treatment | Week 264; n=15, 18, 24, 0 | 12 Participants |
| GSK1265744 10 mg | Number of Participants With Adherence to Study Treatment | Week 108; n=23, 23, 29, 0 | 21 Participants |
| GSK1265744 10 mg | Number of Participants With Adherence to Study Treatment | Week 96; n=31, 36, 33, 0 | 25 Participants |
| GSK1265744 10 mg | Number of Participants With Adherence to Study Treatment | Week 36; n=46, 48, 50, 41 | 40 Participants |
| GSK1265744 10 mg | Number of Participants With Adherence to Study Treatment | Week 8; n=53, 50, 56, 48 | 49 Participants |
| GSK1265744 10 mg | Number of Participants With Adherence to Study Treatment | Week 84; n=36, 39, 42, 33 | 34 Participants |
| GSK1265744 10 mg | Number of Participants With Adherence to Study Treatment | Week 72; n=35, 37, 44, 32 | 32 Participants |
| GSK1265744 10 mg | Number of Participants With Adherence to Study Treatment | Week 40; n=38, 35, 45, 39 | 33 Participants |
| GSK1265744 10 mg | Number of Participants With Adherence to Study Treatment | Week 312; n=1, 1, 0, 0 | 1 Participants |
| GSK1265744 10 mg | Number of Participants With Adherence to Study Treatment | Week 60; n=38, 38, 40, 37 | 37 Participants |
| GSK1265744 10 mg | Number of Participants With Adherence to Study Treatment | Week 48; n=33, 37, 45, 35 | 32 Participants |
| GSK1265744 10 mg | Number of Participants With Adherence to Study Treatment | Week 252; n=23, 26, 33, 0 | 18 Participants |
| GSK1265744 10 mg | Number of Participants With Adherence to Study Treatment | Week 240; n=28, 26, 41, 0 | 28 Participants |
| GSK1265744 10 mg | Number of Participants With Adherence to Study Treatment | Week 12; n=55, 48, 53, 48 | 44 Participants |
| GSK1265744 10 mg | Number of Participants With Adherence to Study Treatment | Week 300; n=12, 13, 20, 0 | 11 Participants |
| GSK1265744 10 mg | Number of Participants With Adherence to Study Treatment | Week 228; n=27, 34, 40, 0 | 25 Participants |
| GSK1265744 10 mg | Number of Participants With Adherence to Study Treatment | Week 216; n=29, 30, 37, 0 | 29 Participants |
| GSK1265744 10 mg | Number of Participants With Adherence to Study Treatment | Week 16; n=53, 51, 53, 44 | 44 Participants |
| GSK1265744 10 mg | Number of Participants With Adherence to Study Treatment | Week 288; n=12, 14, 18, 0 | 12 Participants |
| GSK1265744 10 mg | Number of Participants With Adherence to Study Treatment | Week 204; n=29, 32, 38, 0 | 27 Participants |
| GSK1265744 10 mg | Number of Participants With Adherence to Study Treatment | Week 192; n=30, 30, 39, 0 | 28 Participants |
| GSK1265744 10 mg | Number of Participants With Adherence to Study Treatment | Week 20; n=51, 49, 55, 44 | 45 Participants |
| GSK1265744 10 mg | Number of Participants With Adherence to Study Treatment | Week 4; n=54, 52, 53, 50 | 46 Participants |
| GSK1265744 10 mg | Number of Participants With Adherence to Study Treatment | Week 180; n=26, 29, 39, 0 | 24 Participants |
| GSK1265744 10 mg | Number of Participants With Adherence to Study Treatment | Week 168; n=29, 33, 41, 0 | 29 Participants |
| GSK1265744 10 mg | Number of Participants With Adherence to Study Treatment | Week 24; n=51, 46, 51, 43 | 47 Participants |
| GSK1265744 10 mg | Number of Participants With Adherence to Study Treatment | Baseline; n=57, 55, 56, 52 | 53 Participants |
| GSK1265744 10 mg | Number of Participants With Adherence to Study Treatment | Week 156; n=31, 28, 39, 0 | 30 Participants |
| GSK1265744 10 mg | Number of Participants With Adherence to Study Treatment | Week 144; n=33, 34, 43, 0 | 32 Participants |
| GSK1265744 10 mg | Number of Participants With Adherence to Study Treatment | Week 28; n=49, 48, 53, 41 | 45 Participants |
| GSK1265744 10 mg | Number of Participants With Adherence to Study Treatment | Week 276; n=14, 14, 21, 0 | 13 Participants |
| GSK1265744 10 mg | Number of Participants With Adherence to Study Treatment | Week 132; n=29, 32, 40, 0 | 28 Participants |
| GSK1265744 10 mg | Number of Participants With Adherence to Study Treatment | Week 120; n=30, 38, 41, 0 | 28 Participants |
| GSK1265744 10 mg | Number of Participants With Adherence to Study Treatment | Week 32; n=47, 48, 55, 41 | 46 Participants |
| GSK1265744 30 mg | Number of Participants With Adherence to Study Treatment | Week 12; n=55, 48, 53, 48 | 40 Participants |
| GSK1265744 30 mg | Number of Participants With Adherence to Study Treatment | Baseline; n=57, 55, 56, 52 | 51 Participants |
| GSK1265744 30 mg | Number of Participants With Adherence to Study Treatment | Week 4; n=54, 52, 53, 50 | 49 Participants |
| GSK1265744 30 mg | Number of Participants With Adherence to Study Treatment | Week 8; n=53, 50, 56, 48 | 45 Participants |
| GSK1265744 30 mg | Number of Participants With Adherence to Study Treatment | Week 16; n=53, 51, 53, 44 | 45 Participants |
| GSK1265744 30 mg | Number of Participants With Adherence to Study Treatment | Week 20; n=51, 49, 55, 44 | 40 Participants |
| GSK1265744 30 mg | Number of Participants With Adherence to Study Treatment | Week 24; n=51, 46, 51, 43 | 41 Participants |
| GSK1265744 30 mg | Number of Participants With Adherence to Study Treatment | Week 28; n=49, 48, 53, 41 | 46 Participants |
| GSK1265744 30 mg | Number of Participants With Adherence to Study Treatment | Week 32; n=47, 48, 55, 41 | 42 Participants |
| GSK1265744 30 mg | Number of Participants With Adherence to Study Treatment | Week 36; n=46, 48, 50, 41 | 43 Participants |
| GSK1265744 30 mg | Number of Participants With Adherence to Study Treatment | Week 40; n=38, 35, 45, 39 | 30 Participants |
| GSK1265744 30 mg | Number of Participants With Adherence to Study Treatment | Week 48; n=33, 37, 45, 35 | 33 Participants |
| GSK1265744 30 mg | Number of Participants With Adherence to Study Treatment | Week 60; n=38, 38, 40, 37 | 35 Participants |
| GSK1265744 30 mg | Number of Participants With Adherence to Study Treatment | Week 72; n=35, 37, 44, 32 | 35 Participants |
| GSK1265744 30 mg | Number of Participants With Adherence to Study Treatment | Week 84; n=36, 39, 42, 33 | 36 Participants |
| GSK1265744 30 mg | Number of Participants With Adherence to Study Treatment | Week 96; n=31, 36, 33, 0 | 32 Participants |
| GSK1265744 30 mg | Number of Participants With Adherence to Study Treatment | Week 108; n=23, 23, 29, 0 | 20 Participants |
| GSK1265744 30 mg | Number of Participants With Adherence to Study Treatment | Week 120; n=30, 38, 41, 0 | 36 Participants |
| GSK1265744 30 mg | Number of Participants With Adherence to Study Treatment | Week 132; n=29, 32, 40, 0 | 30 Participants |
| GSK1265744 30 mg | Number of Participants With Adherence to Study Treatment | Week 144; n=33, 34, 43, 0 | 29 Participants |
| GSK1265744 30 mg | Number of Participants With Adherence to Study Treatment | Week 156; n=31, 28, 39, 0 | 25 Participants |
| GSK1265744 30 mg | Number of Participants With Adherence to Study Treatment | Week 168; n=29, 33, 41, 0 | 24 Participants |
| GSK1265744 30 mg | Number of Participants With Adherence to Study Treatment | Week 180; n=26, 29, 39, 0 | 24 Participants |
| GSK1265744 30 mg | Number of Participants With Adherence to Study Treatment | Week 192; n=30, 30, 39, 0 | 27 Participants |
| GSK1265744 30 mg | Number of Participants With Adherence to Study Treatment | Week 204; n=29, 32, 38, 0 | 26 Participants |
| GSK1265744 30 mg | Number of Participants With Adherence to Study Treatment | Week 216; n=29, 30, 37, 0 | 27 Participants |
| GSK1265744 30 mg | Number of Participants With Adherence to Study Treatment | Week 228; n=27, 34, 40, 0 | 28 Participants |
| GSK1265744 30 mg | Number of Participants With Adherence to Study Treatment | Week 240; n=28, 26, 41, 0 | 22 Participants |
| GSK1265744 30 mg | Number of Participants With Adherence to Study Treatment | Week 252; n=23, 26, 33, 0 | 21 Participants |
| GSK1265744 30 mg | Number of Participants With Adherence to Study Treatment | Week 264; n=15, 18, 24, 0 | 16 Participants |
| GSK1265744 30 mg | Number of Participants With Adherence to Study Treatment | Week 276; n=14, 14, 21, 0 | 13 Participants |
| GSK1265744 30 mg | Number of Participants With Adherence to Study Treatment | Week 288; n=12, 14, 18, 0 | 10 Participants |
| GSK1265744 30 mg | Number of Participants With Adherence to Study Treatment | Week 300; n=12, 13, 20, 0 | 7 Participants |
| GSK1265744 30 mg | Number of Participants With Adherence to Study Treatment | Week 312; n=1, 1, 0, 0 | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Adherence to Study Treatment | Week 240; n=28, 26, 41, 0 | 35 Participants |
| GSK1265744 60 mg | Number of Participants With Adherence to Study Treatment | Week 120; n=30, 38, 41, 0 | 39 Participants |
| GSK1265744 60 mg | Number of Participants With Adherence to Study Treatment | Week 28; n=49, 48, 53, 41 | 48 Participants |
| GSK1265744 60 mg | Number of Participants With Adherence to Study Treatment | Week 8; n=53, 50, 56, 48 | 53 Participants |
| GSK1265744 60 mg | Number of Participants With Adherence to Study Treatment | Week 132; n=29, 32, 40, 0 | 35 Participants |
| GSK1265744 60 mg | Number of Participants With Adherence to Study Treatment | Week 204; n=29, 32, 38, 0 | 33 Participants |
| GSK1265744 60 mg | Number of Participants With Adherence to Study Treatment | Baseline; n=57, 55, 56, 52 | 55 Participants |
| GSK1265744 60 mg | Number of Participants With Adherence to Study Treatment | Week 216; n=29, 30, 37, 0 | 31 Participants |
| GSK1265744 60 mg | Number of Participants With Adherence to Study Treatment | Week 48; n=33, 37, 45, 35 | 41 Participants |
| GSK1265744 60 mg | Number of Participants With Adherence to Study Treatment | Week 40; n=38, 35, 45, 39 | 41 Participants |
| GSK1265744 60 mg | Number of Participants With Adherence to Study Treatment | Week 12; n=55, 48, 53, 48 | 46 Participants |
| GSK1265744 60 mg | Number of Participants With Adherence to Study Treatment | Week 60; n=38, 38, 40, 37 | 37 Participants |
| GSK1265744 60 mg | Number of Participants With Adherence to Study Treatment | Week 276; n=14, 14, 21, 0 | 18 Participants |
| GSK1265744 60 mg | Number of Participants With Adherence to Study Treatment | Week 72; n=35, 37, 44, 32 | 41 Participants |
| GSK1265744 60 mg | Number of Participants With Adherence to Study Treatment | Week 36; n=46, 48, 50, 41 | 48 Participants |
| GSK1265744 60 mg | Number of Participants With Adherence to Study Treatment | Week 228; n=27, 34, 40, 0 | 35 Participants |
| GSK1265744 60 mg | Number of Participants With Adherence to Study Treatment | Week 84; n=36, 39, 42, 33 | 39 Participants |
| GSK1265744 60 mg | Number of Participants With Adherence to Study Treatment | Week 96; n=31, 36, 33, 0 | 30 Participants |
| GSK1265744 60 mg | Number of Participants With Adherence to Study Treatment | Week 32; n=47, 48, 55, 41 | 52 Participants |
| GSK1265744 60 mg | Number of Participants With Adherence to Study Treatment | Week 108; n=23, 23, 29, 0 | 27 Participants |
| GSK1265744 60 mg | Number of Participants With Adherence to Study Treatment | Week 300; n=12, 13, 20, 0 | 18 Participants |
| GSK1265744 60 mg | Number of Participants With Adherence to Study Treatment | Week 144; n=33, 34, 43, 0 | 41 Participants |
| GSK1265744 60 mg | Number of Participants With Adherence to Study Treatment | Week 24; n=51, 46, 51, 43 | 48 Participants |
| GSK1265744 60 mg | Number of Participants With Adherence to Study Treatment | Week 252; n=23, 26, 33, 0 | 29 Participants |
| GSK1265744 60 mg | Number of Participants With Adherence to Study Treatment | Week 156; n=31, 28, 39, 0 | 35 Participants |
| GSK1265744 60 mg | Number of Participants With Adherence to Study Treatment | Week 168; n=29, 33, 41, 0 | 35 Participants |
| GSK1265744 60 mg | Number of Participants With Adherence to Study Treatment | Week 20; n=51, 49, 55, 44 | 51 Participants |
| GSK1265744 60 mg | Number of Participants With Adherence to Study Treatment | Week 288; n=12, 14, 18, 0 | 17 Participants |
| GSK1265744 60 mg | Number of Participants With Adherence to Study Treatment | Week 180; n=26, 29, 39, 0 | 34 Participants |
| GSK1265744 60 mg | Number of Participants With Adherence to Study Treatment | Week 264; n=15, 18, 24, 0 | 21 Participants |
| GSK1265744 60 mg | Number of Participants With Adherence to Study Treatment | Week 192; n=30, 30, 39, 0 | 35 Participants |
| GSK1265744 60 mg | Number of Participants With Adherence to Study Treatment | Week 16; n=53, 51, 53, 44 | 50 Participants |
| GSK1265744 60 mg | Number of Participants With Adherence to Study Treatment | Week 4; n=54, 52, 53, 50 | 52 Participants |
| Efavirenz 600 mg | Number of Participants With Adherence to Study Treatment | Week 24; n=51, 46, 51, 43 | 39 Participants |
| Efavirenz 600 mg | Number of Participants With Adherence to Study Treatment | Week 28; n=49, 48, 53, 41 | 35 Participants |
| Efavirenz 600 mg | Number of Participants With Adherence to Study Treatment | Week 60; n=38, 38, 40, 37 | 35 Participants |
| Efavirenz 600 mg | Number of Participants With Adherence to Study Treatment | Week 36; n=46, 48, 50, 41 | 36 Participants |
| Efavirenz 600 mg | Number of Participants With Adherence to Study Treatment | Week 12; n=55, 48, 53, 48 | 43 Participants |
| Efavirenz 600 mg | Number of Participants With Adherence to Study Treatment | Week 84; n=36, 39, 42, 33 | 29 Participants |
| Efavirenz 600 mg | Number of Participants With Adherence to Study Treatment | Week 20; n=51, 49, 55, 44 | 41 Participants |
| Efavirenz 600 mg | Number of Participants With Adherence to Study Treatment | Week 4; n=54, 52, 53, 50 | 44 Participants |
| Efavirenz 600 mg | Number of Participants With Adherence to Study Treatment | Week 40; n=38, 35, 45, 39 | 34 Participants |
| Efavirenz 600 mg | Number of Participants With Adherence to Study Treatment | Week 32; n=47, 48, 55, 41 | 37 Participants |
| Efavirenz 600 mg | Number of Participants With Adherence to Study Treatment | Week 72; n=35, 37, 44, 32 | 27 Participants |
| Efavirenz 600 mg | Number of Participants With Adherence to Study Treatment | Week 48; n=33, 37, 45, 35 | 33 Participants |
| Efavirenz 600 mg | Number of Participants With Adherence to Study Treatment | Week 16; n=53, 51, 53, 44 | 42 Participants |
| Efavirenz 600 mg | Number of Participants With Adherence to Study Treatment | Week 8; n=53, 50, 56, 48 | 47 Participants |
| Efavirenz 600 mg | Number of Participants With Adherence to Study Treatment | Baseline; n=57, 55, 56, 52 | 48 Participants |
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Maintenance Phase
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. Maintenance Safety Population comprised of all participants randomized to GSK1265744 and who were exposed to investigational products during the maintenance phase of the study with the exception of any participants with documented evidence of not having consumed any amount of investigational product.
Time frame: Week 24 to Week 96
Population: Maintenance Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1265744 10 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Maintenance Phase | Any AE | 40 Participants |
| GSK1265744 10 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Maintenance Phase | Any SAE | 5 Participants |
| GSK1265744 30 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Maintenance Phase | Any SAE | 5 Participants |
| GSK1265744 30 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Maintenance Phase | Any AE | 50 Participants |
| GSK1265744 60 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Maintenance Phase | Any AE | 50 Participants |
| GSK1265744 60 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Maintenance Phase | Any SAE | 5 Participants |
| Efavirenz 600 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Maintenance Phase | Any AE | 35 Participants |
| Efavirenz 600 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Maintenance Phase | Any SAE | 2 Participants |
Secondary
Number of Participants With AEs and SAEs-Induction Phase
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia.
Time frame: Up to Week 24
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1265744 10 mg | Number of Participants With AEs and SAEs-Induction Phase | Any AE | 54 Participants |
| GSK1265744 10 mg | Number of Participants With AEs and SAEs-Induction Phase | Any SAE | 2 Participants |
| GSK1265744 30 mg | Number of Participants With AEs and SAEs-Induction Phase | Any SAE | 0 Participants |
| GSK1265744 30 mg | Number of Participants With AEs and SAEs-Induction Phase | Any AE | 54 Participants |
| GSK1265744 60 mg | Number of Participants With AEs and SAEs-Induction Phase | Any SAE | 2 Participants |
| GSK1265744 60 mg | Number of Participants With AEs and SAEs-Induction Phase | Any AE | 55 Participants |
| Efavirenz 600 mg | Number of Participants With AEs and SAEs-Induction Phase | Any SAE | 2 Participants |
| Efavirenz 600 mg | Number of Participants With AEs and SAEs-Induction Phase | Any AE | 59 Participants |
Secondary
Number of Participants With AEs and SAEs Over Time
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. Safety Population comprised of all randomized participants who were exposed to investigational products with the exception of any participants with documented evidence of not having consumed any amount of investigational product.
Time frame: Up to Week 324
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1265744 10 mg | Number of Participants With AEs and SAEs Over Time | Any AE | 57 Participants |
| GSK1265744 10 mg | Number of Participants With AEs and SAEs Over Time | Any SAE | 13 Participants |
| GSK1265744 30 mg | Number of Participants With AEs and SAEs Over Time | Any AE | 57 Participants |
| GSK1265744 30 mg | Number of Participants With AEs and SAEs Over Time | Any SAE | 12 Participants |
| GSK1265744 60 mg | Number of Participants With AEs and SAEs Over Time | Any SAE | 11 Participants |
| GSK1265744 60 mg | Number of Participants With AEs and SAEs Over Time | Any AE | 60 Participants |
| Efavirenz 600 mg | Number of Participants With AEs and SAEs Over Time | Any SAE | 4 Participants |
| Efavirenz 600 mg | Number of Participants With AEs and SAEs Over Time | Any AE | 60 Participants |
Secondary
Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
Twelve lead ECG was performed after the participants had rested in a semi-supine position for at least 5 minutes using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for worst case results at any time on-treatment is presented.
Time frame: Up to Week 324
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1265744 10 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings | 25 Participants |
| GSK1265744 30 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings | 19 Participants |
| GSK1265744 60 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings | 15 Participants |
| Efavirenz 600 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings | 10 Participants |
Secondary
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase
Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotranferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), carbon dioxide(CO2)/bicarbonate, cholesterol, creatine kinase (CK), creatinine, glucose, low density lipoprotein (LDL) cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin and triglycerides. A toxicity is considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
Time frame: Week 24 to Week 96
Population: Maintenance Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | AST; Grade 1 | 5 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Total bilirubin; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | ALP; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Triglycerides; Grade 2 | 1 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Inorganic phosphorus; Grade 2 | 10 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Total bilirubin; Grade 1 | 7 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Total bilirubin; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Triglycerides; Grade 3 | 1 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | CO2/bicarbonate; Grade 2 | 1 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | ALP; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | ALP; Grade 2 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Triglycerides; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | LDL cholesterol; Grade 3 | 4 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | ALP; Grade 1 | 2 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Albumin; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Albumin; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Albumin; Grade 2 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | ALT; Grade 1 | 9 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | CK; Grade 3 | 3 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Albumin; Grade 1 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | ALT; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | ALT; Grade 2 | 6 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Sodium; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Inorganic phosphorus; Grade 1 | 5 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | LDL cholesterol; Grade 2 | 6 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | LDL cholesterol; Grade 1 | 14 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Glucose; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Inorganic phosphorus; Grade 3 | 2 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Lipase; Grade 4 | 2 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Glucose; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Glucose; Grade 2 | 14 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Inorganic phosphorus; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Potassium; Grade 2 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Glucose; Grade 1 | 17 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Creatinine; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Potassium; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Creatinine; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Potassium; Grade 1 | 12 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Potassium; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Creatinine; Grade 2 | 1 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Creatinine; Grade 1 | 1 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Lipase; Grade 3 | 5 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | CK; Grade 4 | 6 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | CK; Grade 2 | 2 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Lipase; Grade 2 | 9 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | CK; Grade 1 | 8 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Cholesterol; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Sodium; Grade 1 | 14 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Lipase; Grade 1 | 9 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Cholesterol; Grade 3 | 3 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Cholesterol; Grade 2 | 6 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Sodium; Grade 2 | 2 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Cholesterol; Grade 1 | 17 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | CO2/bicarbonate; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Sodium; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | CO2/bicarbonate; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | CO2/bicarbonate; Grade 1 | 6 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | AST; Grade 4 | 2 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Total bilirubin; Grade 2 | 2 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | LDL cholesterol; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | AST; Grade 3 | 2 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | AST; Grade 2 | 5 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Triglycerides; Grade 1 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | ALT; Grade 4 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Inorganic phosphorus; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Sodium; Grade 2 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Sodium; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Sodium; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Total bilirubin; Grade 1 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Total bilirubin; Grade 2 | 3 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | ALT; Grade 4 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | AST; Grade 1 | 13 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Potassium; Grade 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Inorganic phosphorus; Grade 2 | 11 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Inorganic phosphorus; Grade 3 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Potassium; Grade 1 | 7 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Potassium; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Potassium; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Sodium; Grade 1 | 12 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Total bilirubin; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Triglycerides; Grade 1 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Triglycerides; Grade 2 | 4 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Total bilirubin; Grade 3 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Triglycerides; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Triglycerides; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | ALT; Grade 1 | 12 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | ALT; Grade 2 | 6 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | ALT; Grade 3 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Albumin; Grade 1 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Albumin; Grade 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Albumin; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Albumin; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | ALP; Grade 1 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | ALP; Grade 2 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | ALP; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | ALP; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | AST; Grade 2 | 8 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | AST; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | AST; Grade 4 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | CO2/bicarbonate; Grade 1 | 14 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | CO2/bicarbonate; Grade 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | CO2/bicarbonate; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | CO2/bicarbonate; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Cholesterol; Grade 1 | 17 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Cholesterol; Grade 2 | 12 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Cholesterol; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Cholesterol; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | CK; Grade 1 | 9 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | CK; Grade 2 | 4 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | CK; Grade 3 | 2 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | CK; Grade 4 | 6 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Creatinine; Grade 1 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Creatinine; Grade 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Creatinine; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Creatinine; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Glucose; Grade 1 | 17 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Glucose; Grade 2 | 10 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Glucose; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Glucose; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | LDL cholesterol; Grade 1 | 16 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | LDL cholesterol; Grade 2 | 11 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | LDL cholesterol; Grade 3 | 2 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | LDL cholesterol; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Lipase; Grade 1 | 9 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Lipase; Grade 2 | 8 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Lipase; Grade 3 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Lipase; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Inorganic phosphorus; Grade 1 | 3 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Triglycerides; Grade 1 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | AST; Grade 2 | 5 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Total bilirubin; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | LDL cholesterol; Grade 2 | 14 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | AST; Grade 3 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | AST; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | CO2/bicarbonate; Grade 1 | 9 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Lipase; Grade 4 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | CO2/bicarbonate; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Sodium; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | LDL cholesterol; Grade 3 | 7 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | CO2/bicarbonate; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | CO2/bicarbonate; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Sodium; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Cholesterol; Grade 1 | 19 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Cholesterol; Grade 2 | 15 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Sodium; Grade 1 | 16 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | LDL cholesterol; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Cholesterol; Grade 3 | 3 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Cholesterol; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Potassium; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Total bilirubin; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | CK; Grade 1 | 11 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Total bilirubin; Grade 1 | 8 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | CK; Grade 2 | 4 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Lipase; Grade 1 | 8 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | CK; Grade 3 | 4 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Potassium; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | CK; Grade 4 | 5 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Creatinine; Grade 1 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Potassium; Grade 1 | 8 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Sodium; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Creatinine; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Lipase; Grade 2 | 11 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Creatinine; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Creatinine; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Inorganic phosphorus; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Total bilirubin; Grade 2 | 4 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Glucose; Grade 1 | 20 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Inorganic phosphorus; Grade 1 | 9 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Glucose; Grade 2 | 11 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Inorganic phosphorus; Grade 3 | 5 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Lipase; Grade 3 | 6 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Glucose; Grade 3 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | ALT; Grade 2 | 5 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Potassium; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | ALT; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | ALT; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | ALT; Grade 1 | 17 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Albumin; Grade 1 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Glucose; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Albumin; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Triglycerides; Grade 2 | 3 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Albumin; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Albumin; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Triglycerides; Grade 4 | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | ALP; Grade 1 | 4 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | LDL cholesterol; Grade 1 | 13 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | ALP; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Triglycerides; Grade 3 | 3 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | ALP; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Inorganic phosphorus; Grade 2 | 5 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | ALP; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | AST; Grade 1 | 13 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Total bilirubin; Grade 1 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | AST; Grade 1 | 5 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Total bilirubin; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Inorganic phosphorus; Grade 1 | 7 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Lipase; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | AST; Grade 2 | 2 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Creatinine; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Inorganic phosphorus; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | LDL cholesterol; Grade 1 | 8 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | AST; Grade 3 | 3 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Sodium; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | LDL cholesterol; Grade 2 | 6 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Albumin; Grade 1 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | AST; Grade 4 | 2 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Sodium; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | CK; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Creatinine; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | CO2/bicarbonate; Grade 1 | 8 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Potassium; Grade 2 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Lipase; Grade 2 | 7 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | CO2/bicarbonate; Grade 2 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Triglycerides; Grade 2 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Creatinine; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | ALP; Grade 1 | 4 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | CO2/bicarbonate; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Sodium; Grade 2 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | LDL cholesterol; Grade 3 | 4 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Triglycerides; Grade 3 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | CO2/bicarbonate; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Albumin; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Total bilirubin; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Glucose; Grade 1 | 11 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Cholesterol; Grade 1 | 9 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Sodium; Grade 1 | 7 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Lipase; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Inorganic phosphorus; Grade 3 | 2 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Cholesterol; Grade 2 | 10 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | ALP; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Glucose; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Glucose; Grade 2 | 5 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Cholesterol; Grade 3 | 4 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Potassium; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | LDL cholesterol; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | ALP; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Cholesterol; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Albumin; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Triglycerides; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Glucose; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | CK; Grade 1 | 5 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Potassium; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Inorganic phosphorus; Grade 2 | 9 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | ALT; Grade 2 | 3 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | ALT; Grade 1 | 6 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | ALP; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | CK; Grade 3 | 3 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Albumin; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Lipase; Grade 1 | 9 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | ALT; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | CK; Grade 4 | 5 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Potassium; Grade 1 | 4 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Total bilirubin; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Triglycerides; Grade 1 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | Creatinine; Grade 1 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase | ALT; Grade 4 | 1 Participants |
Secondary
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time
Blood samples were collected for the analysis of following clinical chemistry parameters: ALT, albumin, ALP, AST, CO2/bicarbonate, cholesterol, CK, creatinine, glucose, LDL cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin and triglycerides. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
Time frame: Up to Week 324
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | ALT; Grade 2 | 6 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Albumin; Grade 2 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Cholesterol; Grade 2 | 7 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | CK; Grade 1 | 9 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Glucose; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Triglycerides; Grade 3 | 1 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | ALT; Grade 1 | 9 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | ALT; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | ALT; Grade 4 | 1 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Albumin; Grade 1 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | ALP; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | ALP; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | AST; Grade 1 | 7 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Albumin; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Albumin; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | ALP; Grade 1 | 2 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | ALP; Grade 2 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | AST; Grade 2 | 6 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | AST; Grade 3 | 2 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | AST; Grade 4 | 2 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | CO2/bicarbonate; Grade 1 | 6 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Cholesterol; Grade 3 | 3 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | CO2/bicarbonate; Grade 2 | 1 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | CO2/bicarbonate; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | CO2/bicarbonate; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Cholesterol; Grade 1 | 17 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Cholesterol; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | CK; Grade 2 | 2 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | CK; Grade 3 | 3 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | CK; Grade 4 | 7 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Creatinine; Grade 1 | 1 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Creatinine; Grade 2 | 1 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Glucose; Grade 1 | 19 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Glucose; Grade 2 | 14 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Creatinine; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Creatinine; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Glucose; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | LDL cholesterol; Grade 1 | 14 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | LDL cholesterol; Grade 2 | 7 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | LDL cholesterol; Grade 3 | 4 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | LDL cholesterol; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Lipase; Grade 1 | 11 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Lipase; Grade 2 | 9 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Lipase; Grade 3 | 5 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Lipase; Grade 4 | 2 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Inorganic phosphorus; Grade 1 | 5 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Inorganic phosphorus; Grade 2 | 11 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Inorganic phosphorus; Grade 3 | 2 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Inorganic phosphorus; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Potassium; Grade 1 | 14 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Potassium; Grade 2 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Potassium; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Potassium; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Sodium; Grade 1 | 14 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Sodium; Grade 2 | 2 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Sodium; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Sodium; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Total bilirubin; Grade 1 | 7 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Total bilirubin; Grade 2 | 2 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Total bilirubin; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Total bilirubin; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Triglycerides; Grade 1 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Triglycerides; Grade 2 | 1 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Triglycerides; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Total bilirubin; Grade 3 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Albumin; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | AST; Grade 1 | 13 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | AST; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Cholesterol; Grade 2 | 12 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Cholesterol; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | CK; Grade 1 | 10 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Glucose; Grade 2 | 10 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | AST; Grade 2 | 8 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Inorganic phosphorus; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Glucose; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Total bilirubin; Grade 1 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Cholesterol; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Triglycerides; Grade 1 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Triglycerides; Grade 2 | 4 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | ALT; Grade 1 | 12 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | ALT; Grade 2 | 6 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | CK; Grade 2 | 4 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Total bilirubin; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | ALT; Grade 3 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Sodium; Grade 2 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Potassium; Grade 1 | 7 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | ALT; Grade 4 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | CK; Grade 3 | 2 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Albumin; Grade 1 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | ALP; Grade 2 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | ALP; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | CK; Grade 4 | 6 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | ALP; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Potassium; Grade 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Albumin; Grade 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | AST; Grade 4 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Creatinine; Grade 1 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | ALP; Grade 1 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Sodium; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Glucose; Grade 1 | 18 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Potassium; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Creatinine; Grade 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | CO2/bicarbonate; Grade 1 | 14 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Creatinine; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Triglycerides; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Creatinine; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Sodium; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Glucose; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Albumin; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | LDL cholesterol; Grade 1 | 17 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | CO2/bicarbonate; Grade 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | LDL cholesterol; Grade 2 | 11 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Potassium; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | LDL cholesterol; Grade 3 | 2 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | LDL cholesterol; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | CO2/bicarbonate; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Lipase; Grade 1 | 9 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Triglycerides; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Lipase; Grade 2 | 8 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Sodium; Grade 1 | 12 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Total bilirubin; Grade 2 | 3 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Lipase; Grade 3 | 2 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | CO2/bicarbonate; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Lipase; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Inorganic phosphorus; Grade 1 | 3 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Inorganic phosphorus; Grade 2 | 11 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Cholesterol; Grade 1 | 17 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Inorganic phosphorus; Grade 3 | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | LDL cholesterol; Grade 2 | 14 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Inorganic phosphorus; Grade 3 | 5 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Inorganic phosphorus; Grade 2 | 6 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Creatinine; Grade 1 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | AST; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Cholesterol; Grade 1 | 19 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | AST; Grade 1 | 15 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Triglycerides; Grade 2 | 3 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Inorganic phosphorus; Grade 1 | 10 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Cholesterol; Grade 3 | 3 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Cholesterol; Grade 2 | 15 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Total bilirubin; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Triglycerides; Grade 4 | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | CK; Grade 2 | 4 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Creatinine; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Potassium; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Glucose; Grade 1 | 21 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Glucose; Grade 2 | 11 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Total bilirubin; Grade 1 | 8 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Sodium; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Lipase; Grade 3 | 6 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | LDL cholesterol; Grade 3 | 7 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | AST; Grade 2 | 5 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Glucose; Grade 3 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Potassium; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | LDL cholesterol; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Sodium; Grade 1 | 16 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Cholesterol; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Inorganic phosphorus; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | CK; Grade 1 | 12 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Albumin; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Creatinine; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | ALT; Grade 1 | 19 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Triglycerides; Grade 1 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | CO2/bicarbonate; Grade 1 | 9 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | ALT; Grade 2 | 5 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | CO2/bicarbonate; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Total bilirubin; Grade 2 | 4 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Creatinine; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | ALT; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | ALP; Grade 1 | 4 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Lipase; Grade 1 | 9 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Albumin; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | ALT; Grade 4 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Glucose; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Potassium; Grade 1 | 8 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Triglycerides; Grade 3 | 3 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Albumin; Grade 1 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Sodium; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | ALP; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | CK; Grade 3 | 4 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | AST; Grade 3 | 4 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Lipase; Grade 4 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | ALP; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Sodium; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | LDL cholesterol; Grade 1 | 13 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Lipase; Grade 2 | 11 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | ALP; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | CK; Grade 4 | 5 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | CO2/bicarbonate; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Total bilirubin; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | CO2/bicarbonate; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Albumin; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Potassium; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Albumin; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Albumin; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Potassium; Grade 2 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Albumin; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | ALP; Grade 1 | 5 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | AST; Grade 1 | 7 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | AST; Grade 2 | 2 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Potassium; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | AST; Grade 4 | 2 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | CO2/bicarbonate; Grade 1 | 8 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Potassium; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | CO2/bicarbonate; Grade 2 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | CO2/bicarbonate; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Cholesterol; Grade 1 | 9 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Cholesterol; Grade 2 | 10 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Cholesterol; Grade 3 | 6 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Sodium; Grade 1 | 11 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | CK; Grade 1 | 5 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | CK; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | CK; Grade 3 | 4 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | CK; Grade 4 | 5 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Sodium; Grade 2 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Creatinine; Grade 1 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Triglycerides; Grade 1 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Glucose; Grade 1 | 12 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Creatinine; Grade 2 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Sodium; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Creatinine; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Glucose; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Glucose; Grade 4 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | LDL cholesterol; Grade 1 | 8 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Sodium; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | LDL cholesterol; Grade 2 | 7 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | LDL cholesterol; Grade 3 | 4 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | LDL cholesterol; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Total bilirubin; Grade 1 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Lipase; Grade 1 | 10 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Lipase; Grade 2 | 7 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Lipase; Grade 3 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Total bilirubin; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Inorganic phosphorus; Grade 1 | 8 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Inorganic phosphorus; Grade 2 | 9 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | AST; Grade 3 | 3 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | CO2/bicarbonate; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Inorganic phosphorus; Grade 3 | 2 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Cholesterol; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Creatinine; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Glucose; Grade 2 | 6 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Lipase; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Total bilirubin; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Triglycerides; Grade 2 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Triglycerides; Grade 4 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Inorganic phosphorus; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | ALT; Grade 1 | 8 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | ALT; Grade 2 | 4 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Total bilirubin; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | ALT; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | ALT; Grade 4 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | ALP; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Potassium; Grade 1 | 4 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | ALP; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Triglycerides; Grade 3 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | ALP; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time | Albumin; Grade 1 | 0 Participants |
Secondary
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase
Blood samples were collected for the analysis of following clinical chemistry parameters: ALT, albumin, ALP, AST, CO2/bicarbonate, chloride, cholesterol, CK, creatinine, glucose, high density lipoprotein (HDL) cholesterol, LDL cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin, triglycerides and urea/blood urea nitrogen (BUN). A toxicity was considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
Time frame: Up to Week 24
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Triglycerides; Grade 1 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Total bilirubin; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | CK; Grade 2 | 2 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Total bilirubin; Grade 2 | 2 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Sodium; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Lipase; Grade 1 | 9 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | ALT; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Sodium; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | ALT; Grade 1 | 3 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Lipase; Grade 3 | 2 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | HDL cholesterol; Grade 1 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Sodium; Grade 1 | 7 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Potassium; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Potassium; Grade 2 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Glucose; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Inorganic phosphorus; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Inorganic phosphorus; Grade 3 | 1 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Inorganic phosphorus; Grade 2 | 6 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Glucose; Grade 1 | 10 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Glucose; Grade 2 | 5 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Urea/BUN; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Glucose; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | ALP; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Creatinine; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Creatinine; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Creatinine; Grade 2 | 1 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | HDL cholesterol; Grade 2 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Creatinine; Grade 1 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | CK; Grade 4 | 2 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | HDL cholesterol; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | HDL cholesterol; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | AST; Grade 1 | 6 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | CK; Grade 3 | 3 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | CK; Grade 1 | 7 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | LDL cholesterol; Grade 2 | 4 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Urea/BUN; Grade 2 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | LDL cholesterol; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Urea/BUN; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Cholesterol; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | LDL cholesterol; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Lipase; Grade 2 | 6 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Urea/BUN; Grade 1 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Cholesterol; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Cholesterol; Grade 2 | 3 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Lipase; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Triglycerides; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Cholesterol; Grade 1 | 7 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Inorganic phosphorus; Grade 1 | 5 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Chloride; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Chloride; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Potassium; Grade 1 | 7 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Chloride; Grade 2 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Chloride; Grade 1 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | CO2/bicarbonate; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | CO2/bicarbonate; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Potassium; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | CO2/bicarbonate; Grade 2 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | CO2/bicarbonate; Grade 1 | 1 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | AST; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | AST; Grade 3 | 1 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | AST; Grade 2 | 2 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Sodium; Grade 2 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | ALP; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Total bilirubin; Grade 1 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | ALP; Grade 2 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Total bilirubin; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | ALP; Grade 1 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | LDL cholesterol; Grade 1 | 5 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Albumin; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Albumin; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Albumin; Grade 2 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Albumin; Grade 1 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Triglycerides; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | ALT; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | ALT; Grade 2 | 1 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Triglycerides; Grade 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Sodium; Grade 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | ALT; Grade 1 | 4 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Albumin; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | CO2/bicarbonate; Grade 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | CK; Grade 3 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Glucose; Grade 2 | 3 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Glucose; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | HDL cholesterol; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | LDL cholesterol; Grade 2 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | LDL cholesterol; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Lipase; Grade 2 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Lipase; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Inorganic phosphorus; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Triglycerides; Grade 1 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | LDL cholesterol; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Lipase; Grade 1 | 3 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Lipase; Grade 3 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Inorganic phosphorus; Grade 1 | 2 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Inorganic phosphorus; Grade 2 | 2 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Inorganic phosphorus; Grade 3 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Potassium; Grade 1 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Potassium; Grade 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Potassium; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Potassium; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Sodium; Grade 1 | 4 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Sodium; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Sodium; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Total bilirubin; Grade 1 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Total bilirubin; Grade 2 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Total bilirubin; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Total bilirubin; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Triglycerides; Grade 2 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Triglycerides; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | ALT; Grade 2 | 5 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | ALT; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | ALT; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Albumin; Grade 1 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Albumin; Grade 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Albumin; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | ALP; Grade 1 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | ALP; Grade 2 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | ALP; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | ALP; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | AST; Grade 1 | 8 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | AST; Grade 2 | 5 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | AST; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | AST; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | CO2/bicarbonate; Grade 1 | 5 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | CO2/bicarbonate; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | CO2/bicarbonate; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Chloride; Grade 1 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Chloride; Grade 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Chloride; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Chloride; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Cholesterol; Grade 1 | 8 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Cholesterol; Grade 2 | 2 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Cholesterol; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Cholesterol; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | CK; Grade 1 | 5 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | CK; Grade 2 | 2 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | CK; Grade 4 | 4 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Creatinine; Grade 1 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Creatinine; Grade 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Creatinine; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Creatinine; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Glucose; Grade 1 | 8 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Glucose; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | HDL cholesterol; Grade 1 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | HDL cholesterol; Grade 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | HDL cholesterol; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | LDL cholesterol; Grade 1 | 9 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Triglycerides; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Urea/BUN; Grade 1 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Urea/BUN; Grade 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Urea/BUN; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Urea/BUN; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Triglycerides; Grade 2 | 3 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Cholesterol; Grade 2 | 3 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Albumin; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Lipase; Grade 2 | 7 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Urea/BUN; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Cholesterol; Grade 3 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | AST; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Glucose; Grade 2 | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | ALP; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Cholesterol; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | CK; Grade 3 | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | LDL cholesterol; Grade 1 | 8 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Albumin; Grade 1 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | CK; Grade 1 | 6 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Triglycerides; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | CK; Grade 2 | 3 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Potassium; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | HDL cholesterol; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | CO2/bicarbonate; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Albumin; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Inorganic phosphorus; Grade 2 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | ALP; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | CO2/bicarbonate; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Triglycerides; Grade 3 | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Glucose; Grade 1 | 13 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Inorganic phosphorus; Grade 3 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Potassium; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Inorganic phosphorus; Grade 1 | 7 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | HDL cholesterol; Grade 1 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | CK; Grade 4 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Lipase; Grade 4 | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | CO2/bicarbonate; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | HDL cholesterol; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Urea/BUN; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | AST; Grade 1 | 7 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Potassium; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Lipase; Grade 3 | 4 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Creatinine; Grade 1 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | ALP; Grade 1 | 4 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Sodium; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Lipase; Grade 1 | 5 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Chloride; Grade 1 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Sodium; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Albumin; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Potassium; Grade 1 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Urea/BUN; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Sodium; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Chloride; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | HDL cholesterol; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Chloride; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | LDL cholesterol; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Creatinine; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Total bilirubin; Grade 2 | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Glucose; Grade 3 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Inorganic phosphorus; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Total bilirubin; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | AST; Grade 2 | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | LDL cholesterol; Grade 3 | 3 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Chloride; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Total bilirubin; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Total bilirubin; Grade 1 | 4 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | LDL cholesterol; Grade 2 | 5 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Urea/BUN; Grade 1 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Creatinine; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | ALT; Grade 1 | 13 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Sodium; Grade 1 | 7 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Triglycerides; Grade 1 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Cholesterol; Grade 1 | 12 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | ALT; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | AST; Grade 3 | 3 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Glucose; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | ALT; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | CO2/bicarbonate; Grade 1 | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | ALT; Grade 4 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | ALP; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Creatinine; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Triglycerides; Grade 2 | 2 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Albumin; Grade 1 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Creatinine; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Albumin; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Triglycerides; Grade 1 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Albumin; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Urea/BUN; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Albumin; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Total bilirubin; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | ALP; Grade 1 | 3 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Glucose; Grade 1 | 6 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | ALP; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Sodium; Grade 2 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | ALP; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Glucose; Grade 2 | 5 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | ALP; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | AST; Grade 1 | 6 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Sodium; Grade 1 | 8 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | AST; Grade 2 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Glucose; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | AST; Grade 3 | 2 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Potassium; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | CK; Grade 3 | 2 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | AST; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Potassium; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | CO2/bicarbonate; Grade 1 | 6 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Potassium; Grade 2 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Urea/BUN; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | CO2/bicarbonate; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | CO2/bicarbonate; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Potassium; Grade 1 | 2 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | ALT; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Chloride; Grade 1 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Chloride; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | HDL cholesterol; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Chloride; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Lipase; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | HDL cholesterol; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Cholesterol; Grade 1 | 4 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Lipase; Grade 2 | 5 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | CK; Grade 1 | 4 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Cholesterol; Grade 2 | 9 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Cholesterol; Grade 3 | 6 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | LDL cholesterol; Grade 3 | 2 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Chloride; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Cholesterol; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Urea/BUN; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | CK; Grade 2 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Inorganic phosphorus; Grade 1 | 6 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | HDL cholesterol; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Triglycerides; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Inorganic phosphorus; Grade 2 | 8 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Triglycerides; Grade 4 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Inorganic phosphorus; Grade 3 | 2 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Inorganic phosphorus; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | CK; Grade 4 | 4 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Lipase; Grade 3 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | CO2/bicarbonate; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Lipase; Grade 1 | 6 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Creatinine; Grade 1 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Sodium; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | LDL cholesterol; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | HDL cholesterol; Grade 1 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Sodium; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | ALT; Grade 2 | 4 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Total bilirubin; Grade 1 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Total bilirubin; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Creatinine; Grade 2 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Total bilirubin; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Glucose; Grade 4 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | LDL cholesterol; Grade 2 | 8 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | ALT; Grade 1 | 8 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | LDL cholesterol; Grade 1 | 4 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Creatinine; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | Urea/BUN; Grade 1 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase | ALT; Grade 4 | 0 Participants |
Secondary
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase
Blood samples were collected for the analysis of following hematology parameters: APTT, basophils, eosinophils, hematocrit, hemoglobin, INR, lymphocytes, mean corpuscle volume (MCV), monocytes, platelet count, PT, red blood cell (RBC) count, total neutrophils and WBC count. A toxicity was considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
Time frame: Up to Week 24
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Basophils; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Hemoglobin; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Hemoglobin; Grade 1 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Hematocrit; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | PT; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | WBC count; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Hematocrit; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Hematocrit; Grade 1 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | RBC; Grade 1 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | RBC; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Eosinophils; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Eosinophils; Grade 2 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | RBC; Grade 2 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Basophils; Grade 1 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | RBC; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | PT; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Eosinophils; Grade 1 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | APTT; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | APTT; Grade 2 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | WBC count; Grade 2 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | APTT; Grade 1 | 1 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | PT; Grade 2 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | PT; Grade 1 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Eosinophils; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | WBC count; Grade 1 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Platelet count; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | WBC count; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Platelet count; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Platelet count; Grade 2 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Hematocrit; Grade 2 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Total neutrophils; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Monocytes; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Monocytes; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Hemoglobin; Grade 2 | 1 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Basophils; Grade 2 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Monocytes; Grade 2 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Monocytes; Grade 1 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | APTT; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | MCV; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | MCV; Grade 1 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Total neutrophils; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Lymphocytes; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | MCV; Grade 2 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Total neutrophils; Grade 2 | 3 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Lymphocytes; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Lymphocytes; Grade 2 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | MCV; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Basophils; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Lymphocytes; Grade 1 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | INR; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Total neutrophils; Grade 1 | 8 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | INR; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | INR; Grade 2 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Platelet count; Grade 1 | 2 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | INR; Grade 1 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Hemoglobin; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | APTT; Grade 1 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | APTT; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | APTT; Grade 4 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Basophils; Grade 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Basophils; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Eosinophils; Grade 1 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Eosinophils; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Hematocrit; Grade 1 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Hematocrit; Grade 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Hemoglobin; Grade 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Lymphocytes; Grade 1 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Lymphocytes; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | MCV; Grade 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | MCV; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Monocytes; Grade 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | PT; Grade 1 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | PT; Grade 4 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | RBC; Grade 1 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | RBC; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Total neutrophils; Grade 2 | 2 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | WBC count; Grade 1 | 2 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | APTT; Grade 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Basophils; Grade 1 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Basophils; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Eosinophils; Grade 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Eosinophils; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Hematocrit; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Hematocrit; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Hemoglobin; Grade 1 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Hemoglobin; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Hemoglobin; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | INR; Grade 1 | 2 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | INR; Grade 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | INR; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | INR; Grade 4 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Lymphocytes; Grade 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Lymphocytes; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | MCV; Grade 1 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | MCV; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Monocytes; Grade 1 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Monocytes; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Monocytes; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Platelet count; Grade 1 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Platelet count; Grade 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Platelet count; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Platelet count; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | PT; Grade 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | PT; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | RBC; Grade 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | RBC; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Total neutrophils; Grade 1 | 6 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Total neutrophils; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Total neutrophils; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | WBC count; Grade 2 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | WBC count; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | WBC count; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Platelet count; Grade 1 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | WBC count; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | MCV; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Total neutrophils; Grade 1 | 8 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Hematocrit; Grade 1 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | APTT; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Platelet count; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Lymphocytes; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Eosinophils; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Hemoglobin; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Platelet count; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | INR; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Lymphocytes; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Eosinophils; Grade 1 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Hemoglobin; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | PT; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | WBC count; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | PT; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Monocytes; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | APTT; Grade 4 | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | MCV; Grade 1 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | APTT; Grade 1 | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Lymphocytes; Grade 1 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Basophils; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | RBC; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Total neutrophils; Grade 2 | 3 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | MCV; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | INR; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Platelet count; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Basophils; Grade 1 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Total neutrophils; Grade 4 | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Basophils; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Monocytes; Grade 1 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | PT; Grade 1 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | APTT; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Eosinophils; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | INR; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | RBC; Grade 1 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | RBC; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Eosinophils; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Monocytes; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | WBC count; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | MCV; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Hematocrit; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | INR; Grade 1 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | PT; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | RBC; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Hematocrit; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Monocytes; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Total neutrophils; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Hematocrit; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Lymphocytes; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Basophils; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Hemoglobin; Grade 1 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | WBC count; Grade 1 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Hemoglobin; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Eosinophils; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Hemoglobin; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Platelet count; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Hemoglobin; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Total neutrophils; Grade 1 | 2 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | INR; Grade 1 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Monocytes; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Basophils; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | INR; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | INR; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | MCV; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | MCV; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Lymphocytes; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Total neutrophils; Grade 3 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Lymphocytes; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | MCV; Grade 1 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Lymphocytes; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Lymphocytes; Grade 1 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | WBC count; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | MCV; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | INR; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Monocytes; Grade 1 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Monocytes; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Hematocrit; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Total neutrophils; Grade 4 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Monocytes; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | APTT; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Platelet count; Grade 1 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Hematocrit; Grade 1 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | WBC count; Grade 1 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Platelet count; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | WBC count; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Platelet count; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Eosinophils; Grade 1 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | APTT; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | PT; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Basophils; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | WBC count; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | APTT; Grade 1 | 3 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Total neutrophils; Grade 2 | 2 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | APTT; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | RBC; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | RBC; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Basophils; Grade 1 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Basophils; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | RBC; Grade 1 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Eosinophils; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Eosinophils; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Hemoglobin; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | PT; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Hematocrit; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Hematocrit; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | PT; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | RBC; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | PT; Grade 1 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase | Hemoglobin; Grade 1 | 0 Participants |
Secondary
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase
Blood samples were collected for the analysis of following hematology parameters: Activated Partial Thromboplastin Time (APTT), hemoglobin, international normalized ratio (INR), platelet count, prothrombin time (PT), total neutrophils and white blood cell (WBC) count. A toxicity is considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
Time frame: Week 24 to Week 96
Population: Maintenance Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Total neutrophils; Grade 2 | 5 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | PT; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | INR; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Total neutrophils; Grade 1 | 7 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | INR; Grade 3 | 1 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | INR; Grade 1 | 2 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Hemoglobin; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Hemoglobin; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | INR; Grade 2 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | WBC count; Grade 1 | 2 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Platelet count; Grade 2 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | WBC count; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Platelet count; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | WBC count; Grade 2 | 1 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Platelet count; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Hemoglobin; Grade 1 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | APTT; Grade 4 | 1 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | PT; Grade 1 | 1 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Hemoglobin; Grade 2 | 1 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | APTT; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | APTT; Grade 2 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | PT; Grade 2 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | WBC count; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Total neutrophils; Grade 4 | 1 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | APTT; Grade 1 | 5 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | PT; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Platelet count; Grade 1 | 4 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Total neutrophils; Grade 3 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Hemoglobin; Grade 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | INR; Grade 1 | 4 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | INR; Grade 2 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | INR; Grade 4 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Platelet count; Grade 1 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Platelet count; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | PT; Grade 1 | 3 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | PT; Grade 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | PT; Grade 3 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Hemoglobin; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Hemoglobin; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | INR; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Platelet count; Grade 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Platelet count; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Total neutrophils; Grade 1 | 9 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Total neutrophils; Grade 2 | 2 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Total neutrophils; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | PT; Grade 4 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Total neutrophils; Grade 4 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | APTT; Grade 1 | 5 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | APTT; Grade 2 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | APTT; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | APTT; Grade 4 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | WBC count; Grade 1 | 5 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | WBC count; Grade 2 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | WBC count; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | WBC count; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Hemoglobin; Grade 1 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | PT; Grade 3 | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | WBC count; Grade 3 | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Total neutrophils; Grade 1 | 10 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | INR; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Total neutrophils; Grade 2 | 3 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Total neutrophils; Grade 4 | 3 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | WBC count; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | PT; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Total neutrophils; Grade 3 | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | APTT; Grade 4 | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | PT; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | APTT; Grade 1 | 5 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | APTT; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | PT; Grade 1 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | INR; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | APTT; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | INR; Grade 2 | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Hemoglobin; Grade 1 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | WBC count; Grade 1 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | INR; Grade 1 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Hemoglobin; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | WBC count; Grade 2 | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Hemoglobin; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Hemoglobin; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Platelet count; Grade 1 | 4 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Platelet count; Grade 2 | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Platelet count; Grade 3 | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Platelet count; Grade 4 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Hemoglobin; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | PT; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | INR; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | INR; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Hemoglobin; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | APTT; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Total neutrophils; Grade 1 | 2 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | WBC count; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Platelet count; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Platelet count; Grade 1 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Total neutrophils; Grade 2 | 3 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Platelet count; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | INR; Grade 2 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | PT; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | WBC count; Grade 1 | 3 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | WBC count; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Platelet count; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Total neutrophils; Grade 3 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | PT; Grade 2 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | INR; Grade 1 | 3 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Hemoglobin; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | WBC count; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | APTT; Grade 1 | 5 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | PT; Grade 1 | 3 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | APTT; Grade 4 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Hemoglobin; Grade 1 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | APTT; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase | Total neutrophils; Grade 4 | 1 Participants |
Secondary
Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time
Blood samples were collected for the analysis of following hematology parameters: APTT, hemoglobin, INR, platelet count, PT, total neutrophils and WBC count. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
Time frame: Up to Week 324
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Total neutrophils; Grade 2 | 5 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Hemoglobin; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | PT; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | WBC count; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | PT; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | INR; Grade 1 | 2 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | PT; Grade 1 | 1 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | APTT; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Total neutrophils; Grade 1 | 7 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | INR; Grade 2 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Total neutrophils; Grade 3 | 1 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | APTT; Grade 2 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Hemoglobin; Grade 1 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | INR; Grade 3 | 1 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Hemoglobin; Grade 2 | 1 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | APTT; Grade 1 | 5 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | WBC count; Grade 1 | 2 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | INR; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | WBC count; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | PT; Grade 2 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | WBC count; Grade 2 | 1 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Platelet count; Grade 1 | 4 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Hemoglobin; Grade 3 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | APTT; Grade 4 | 1 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Total neutrophils; Grade 4 | 1 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Platelet count; Grade 2 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Platelet count; Grade 4 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Platelet count; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | APTT; Grade 4 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Platelet count; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | WBC count; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Platelet count; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Total neutrophils; Grade 2 | 2 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | PT; Grade 1 | 3 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | PT; Grade 4 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | PT; Grade 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | PT; Grade 3 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Hemoglobin; Grade 1 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | WBC count; Grade 2 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Hemoglobin; Grade 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | APTT; Grade 2 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Hemoglobin; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | APTT; Grade 1 | 5 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Hemoglobin; Grade 4 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Total neutrophils; Grade 1 | 9 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | INR; Grade 1 | 4 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | INR; Grade 2 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | APTT; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | WBC count; Grade 1 | 5 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | INR; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | INR; Grade 4 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | WBC count; Grade 3 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Total neutrophils; Grade 4 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Platelet count; Grade 1 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Platelet count; Grade 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Total neutrophils; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | PT; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | APTT; Grade 1 | 5 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | APTT; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | APTT; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | APTT; Grade 4 | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Hemoglobin; Grade 1 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Hemoglobin; Grade 2 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Hemoglobin; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Hemoglobin; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | INR; Grade 1 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | INR; Grade 2 | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | INR; Grade 3 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | INR; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Platelet count; Grade 1 | 4 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Platelet count; Grade 2 | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Platelet count; Grade 3 | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Platelet count; Grade 4 | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | PT; Grade 1 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | PT; Grade 3 | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | PT; Grade 4 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Total neutrophils; Grade 2 | 3 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Total neutrophils; Grade 3 | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Total neutrophils; Grade 4 | 3 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | WBC count; Grade 1 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Total neutrophils; Grade 1 | 10 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | WBC count; Grade 2 | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | WBC count; Grade 3 | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | WBC count; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | APTT; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Total neutrophils; Grade 3 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Platelet count; Grade 1 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | INR; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | WBC count; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Total neutrophils; Grade 4 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | INR; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | INR; Grade 2 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | WBC count; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | PT; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | INR; Grade 1 | 3 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Hemoglobin; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | APTT; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Total neutrophils; Grade 1 | 2 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Hemoglobin; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | WBC count; Grade 1 | 3 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Hemoglobin; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Hemoglobin; Grade 1 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | APTT; Grade 1 | 5 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | PT; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | PT; Grade 2 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | PT; Grade 1 | 3 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | WBC count; Grade 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Platelet count; Grade 4 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | APTT; Grade 4 | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Total neutrophils; Grade 2 | 3 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Platelet count; Grade 3 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time | Platelet count; Grade 2 | 0 Participants |
Secondary
Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease
HIV-1 associated conditions were assessed according to the 1993 Centers for Disease Control and Prevention (CDC) Revised Classification System for HIV Infection in Adults. The clinical categories of HIV infection as per CDC system are class A=Asymptomatic HIV infection or lymphadenopathy or acute HIV infection; class B=symptomatic non-acquired immunodeficiency syndrome (AIDS) conditions and class C=AIDS indicator conditions. Number of participants experiencing disease progression is presented, where disease progression is defined as the progression from Baseline HIV disease status as follows: CDC class A at Baseline to CDC class C event; CDC Class B at Baseline to CDC Class C event; CDC Class C at Baseline to new CDC Class C event; and CDC class A, B or C at Baseline to death.
Time frame: Up to Week 324
Population: ITT-E Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1265744 10 mg | Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease | CDC Class A to CDC Class C | 1 Participants |
| GSK1265744 10 mg | Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease | CDC Class B to CDC Class C | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease | CDC Class C to new CDC Class C | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease | CDC Class A, B or C to Death | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease | CDC Class B to CDC Class C | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease | CDC Class C to new CDC Class C | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease | CDC Class A, B or C to Death | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease | CDC Class A to CDC Class C | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease | CDC Class C to new CDC Class C | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease | CDC Class B to CDC Class C | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease | CDC Class A, B or C to Death | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease | CDC Class A to CDC Class C | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease | CDC Class A, B or C to Death | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease | CDC Class B to CDC Class C | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease | CDC Class A to CDC Class C | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease | CDC Class C to new CDC Class C | 0 Participants |
Secondary
Number of Participants With Treatment Emergent Genotypic Mutations Associated With Development of Resistance
Plasma samples were collected for drug resistance testing. The treatment emergent INI mutations associated with development of resistance to RAL, ELV, dolutegravir (DTG) or GSK1265744 and major resistance mutations to other classes (NRTI, NNRTI, PI) as defined by International AIDS society (IAS)-United States of America (USA) are presented. On-treatment Genotypic Resistance population comprised of all participants in the ITT-E Population with available on-treatment genotypic resistance data, excluding participants who are not protocol-defined virologic failures.
Time frame: Up to Week 324
Population: On-treatment Genotypic resistance Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Genotypic Mutations Associated With Development of Resistance | Any INI mutation | 3 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Genotypic Mutations Associated With Development of Resistance | Any mutation to other classes | 4 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Genotypic Mutations Associated With Development of Resistance | Any INI mutation | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Genotypic Mutations Associated With Development of Resistance | Any mutation to other classes | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Genotypic Mutations Associated With Development of Resistance | Any mutation to other classes | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Genotypic Mutations Associated With Development of Resistance | Any INI mutation | 1 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Genotypic Mutations Associated With Development of Resistance | Any mutation to other classes | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Genotypic Mutations Associated With Development of Resistance | Any INI mutation | 0 Participants |
Secondary
Number of Participants With Treatment Emergent Phenotypic Resistance
Plasma samples were collected for drug resistance testing. Phenotypic resistance data for the following drugs under integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), NRTI and proteasome inhibitor drug classes is presented for participants with confirmed virologic failure: GSK1265744, Raltegravir \[RAL\], Delavirdine \[DLV\], Efavirenz \[EFV\], Etravirine \[ETR\], Nevirapine (NVP), RPV, 3TC, ABC, FTC, TDF, Zidovudine \[ZDV\], Stavudine \[d4T\], Didanosine \[ddI\], Atazanavir/ritonavir \[ATV/r\], Darunavir (DRV)/r, Fosamprenavir/r \[FPV/r\], Indinavir/r \[IDV/r\], Lopinavir/r \[LPV/r\], Nelfinavir \[NFV\], Ritonavir \[RTV\], Saquinavir/r \[SQV/r\], Tipranavir/r \[TPV/r\]. On-treatment Phenotypic Resistance population comprised of all participants in the ITT-E Population with available on-treatment phenotypic resistance data, excluding participants who are not protocol-defined virologic failures.
Time frame: Up to Week 324
Population: On-treatment Phenotypic Resistance Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, ABC; Sensitive; n=6, 2, 2, 5 | 6 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, RTV; Sensitive; n=6, 2, 2, 5 | 6 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, EFV; Resistant; n=6, 2, 2, 5 | 3 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, EFV; Sensitive; n=6, 2, 2, 5 | 3 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, FTC; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, ETR; Resistant; n=6, 2, 2, 5 | 3 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, SQV/r; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, ETR; Partially sensitive; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, FTC; Sensitive; n=6, 2, 2, 5 | 6 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, SQV/r; Partially sensitive; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, SQV/r; Sensitive; n=6, 2, 2, 5 | 6 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, TPV/r; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, TDF; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, TPV/r; Partially sensitive; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, TPV/r; Sensitive; n=6, 2, 2, 5 | 6 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, NVP; Sensitive; n=6, 2, 2, 5 | 3 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, TDF; Partially sensitive; n=6, 2, 2, 5 | 1 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, ETR; Sensitive; n=6, 2, 2, 5 | 3 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, TDF; Sensitive; n=6, 2, 2, 5 | 5 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, RTV; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, ZDV; Resistant; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, ZDV; Sensitive; n=6, 2, 2, 5 | 4 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, d4T; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, NVP; Resistant; n=6, 2, 2, 5 | 3 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, d4T; Sensitive; n=6, 2, 2, 5 | 6 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, RPV; Resistant; n=6, 2, 2, 5 | 3 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, ddI; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, ddI; Partially sensitive; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, ddI; Sensitive; n=6, 2, 2, 5 | 6 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, RPV; Sensitive; n=6, 2, 2, 5 | 3 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, ATV/r; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, ATV/r; Sensitive; n=6, 2, 2, 5 | 6 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, DRV/r; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, DRV/r; Partially sensitive; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, 3TC; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, DRV/r; Sensitive; n=6, 2, 2, 5 | 6 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, FPV/r; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, FPV/r; Partially sensitive; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, DLV; Sensitive; n=6, 2, 2, 5 | 3 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, FPV/r; Sensitive; n=6, 2, 2, 5 | 6 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, 3TC; Sensitive; n=6, 2, 2, 5 | 6 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, IDV/r; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, IDV/r; Sensitive; n=6, 2, 2, 5 | 6 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, LPV/r; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | INI, GSK1265744; Resistant; n=5, 1, 2, 2 | 2 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, LPV/r; Partially sensitive; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, ABC; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | INI, GSK1265744; Sensitive; n=5, 1, 2, 2 | 3 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, LPV/r; Sensitive; n=6, 2, 2, 5 | 6 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | INI, RAL; Resistant; n=5, 1, 2, 2 | 3 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, NFV; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, ABC; Partially sensitive; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | INI, RAL; Sensitive; n=5, 1, 2, 2 | 2 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, NFV; Sensitive; n=6, 2, 2, 5 | 6 Participants |
| GSK1265744 10 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, DLV; Resistant; n=6, 2, 2, 5 | 3 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, LPV/r; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, TDF; Partially sensitive; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, RTV; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, TDF; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | INI, GSK1265744; Resistant; n=5, 1, 2, 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, ZDV; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, NFV; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, ZDV; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, LPV/r; Partially sensitive; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, d4T; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, d4T; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, ABC; Partially sensitive; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, ddI; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, RPV; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, ABC; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, ddI; Partially sensitive; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, ddI; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | INI, GSK1265744; Sensitive; n=5, 1, 2, 2 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, LPV/r; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, ATV/r; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, RPV; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, DRV/r; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, DRV/r; Partially sensitive; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | INI, RAL; Resistant; n=5, 1, 2, 2 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, DRV/r; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, 3TC; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, FPV/r; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, DLV; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, ABC; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, RTV; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, FPV/r; Partially sensitive; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, EFV; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, EFV; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, NFV; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, FTC; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, ETR; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, FPV/r; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, SQV/r; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, ETR; Partially sensitive; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, ATV/r; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, DLV; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, SQV/r; Partially sensitive; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, FTC; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, SQV/r; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, ETR; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, 3TC; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, TPV/r; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, IDV/r; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, NVP; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, TPV/r; Partially sensitive; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, TDF; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | INI, RAL; Sensitive; n=5, 1, 2, 2 | 1 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, NVP; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, TPV/r; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 30 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, IDV/r; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, 3TC; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, TPV/r; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, TDF; Partially sensitive; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, LPV/r; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, DLV; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, TDF; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, SQV/r; Partially sensitive; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, 3TC; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, ABC; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, ZDV; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, NVP; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, TPV/r; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, RTV; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, ZDV; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, IDV/r; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, EFV; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, d4T; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, LPV/r; Partially sensitive; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | INI, GSK1265744; Resistant; n=5, 1, 2, 2 | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, FPV/r; Partially sensitive; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, d4T; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, NFV; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, IDV/r; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, EFV; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, ddI; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, RTV; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, SQV/r; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, NVP; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, ddI; Partially sensitive; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, RPV; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | INI, RAL; Sensitive; n=5, 1, 2, 2 | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, ETR; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, ddI; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, ETR; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, FTC; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, FTC; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, ATV/r; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, FPV/r; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, LPV/r; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, ATV/r; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, RPV; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | INI, GSK1265744; Sensitive; n=5, 1, 2, 2 | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, DRV/r; Partially sensitive; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, DRV/r; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, DLV; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, ABC; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, TDF; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, ABC; Partially sensitive; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, ETR; Partially sensitive; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, TPV/r; Partially sensitive; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, DRV/r; Sensitive; n=6, 2, 2, 5 | 2 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, SQV/r; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | INI, RAL; Resistant; n=5, 1, 2, 2 | 1 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, NFV; Resistant; n=6, 2, 2, 5 | 0 Participants |
| GSK1265744 60 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, FPV/r; Resistant; n=6, 2, 2, 5 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, TPV/r; Sensitive; n=6, 2, 2, 5 | 5 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, RPV; Resistant; n=6, 2, 2, 5 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, 3TC; Sensitive; n=6, 2, 2, 5 | 5 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, ZDV; Sensitive; n=6, 2, 2, 5 | 5 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, IDV/r; Sensitive; n=6, 2, 2, 5 | 5 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, NVP; Sensitive; n=6, 2, 2, 5 | 5 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, RPV; Sensitive; n=6, 2, 2, 5 | 5 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, 3TC; Resistant; n=6, 2, 2, 5 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, ABC; Resistant; n=6, 2, 2, 5 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, ABC; Partially sensitive; n=6, 2, 2, 5 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, ABC; Sensitive; n=6, 2, 2, 5 | 5 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, FTC; Resistant; n=6, 2, 2, 5 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, FTC; Sensitive; n=6, 2, 2, 5 | 5 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, TDF; Resistant; n=6, 2, 2, 5 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, TDF; Partially sensitive; n=6, 2, 2, 5 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, TDF; Sensitive; n=6, 2, 2, 5 | 5 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, ZDV; Resistant; n=6, 2, 2, 5 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, d4T; Resistant; n=6, 2, 2, 5 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, d4T; Sensitive; n=6, 2, 2, 5 | 5 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, ddI; Resistant; n=6, 2, 2, 5 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, ddI; Partially sensitive; n=6, 2, 2, 5 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NRTI, ddI; Sensitive; n=6, 2, 2, 5 | 5 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, ATV/r; Resistant; n=6, 2, 2, 5 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, ATV/r; Sensitive; n=6, 2, 2, 5 | 5 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, DRV/r; Resistant; n=6, 2, 2, 5 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, DRV/r; Partially sensitive; n=6, 2, 2, 5 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, DRV/r; Sensitive; n=6, 2, 2, 5 | 5 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, FPV/r; Resistant; n=6, 2, 2, 5 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, FPV/r; Partially sensitive; n=6, 2, 2, 5 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, FPV/r; Sensitive; n=6, 2, 2, 5 | 5 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, IDV/r; Resistant; n=6, 2, 2, 5 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, LPV/r; Resistant; n=6, 2, 2, 5 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | INI, GSK1265744; Resistant; n=5, 1, 2, 2 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, LPV/r; Partially sensitive; n=6, 2, 2, 5 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | INI, GSK1265744; Sensitive; n=5, 1, 2, 2 | 2 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, LPV/r; Sensitive; n=6, 2, 2, 5 | 5 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, NFV; Resistant; n=6, 2, 2, 5 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, NFV; Sensitive; n=6, 2, 2, 5 | 5 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | INI, RAL; Sensitive; n=5, 1, 2, 2 | 2 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, DLV; Resistant; n=6, 2, 2, 5 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, RTV; Resistant; n=6, 2, 2, 5 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, DLV; Sensitive; n=6, 2, 2, 5 | 5 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, EFV; Resistant; n=6, 2, 2, 5 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, EFV; Sensitive; n=6, 2, 2, 5 | 5 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, RTV; Sensitive; n=6, 2, 2, 5 | 5 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, ETR; Resistant; n=6, 2, 2, 5 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, ETR; Partially sensitive; n=6, 2, 2, 5 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, SQV/r; Resistant; n=6, 2, 2, 5 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, SQV/r; Partially sensitive; n=6, 2, 2, 5 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, SQV/r; Sensitive; n=6, 2, 2, 5 | 5 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, ETR; Sensitive; n=6, 2, 2, 5 | 5 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, TPV/r; Resistant; n=6, 2, 2, 5 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | PI, TPV/r; Partially sensitive; n=6, 2, 2, 5 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | NNRTI, NVP; Resistant; n=6, 2, 2, 5 | 0 Participants |
| Efavirenz 600 mg | Number of Participants With Treatment Emergent Phenotypic Resistance | INI, RAL; Resistant; n=5, 1, 2, 2 | 0 Participants |
Secondary
Percentage of Participants Who Discontinued Investigational Product Due to Adverse Events
AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented.
Time frame: Up to Week 324
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK1265744 10 mg | Percentage of Participants Who Discontinued Investigational Product Due to Adverse Events | 7 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants Who Discontinued Investigational Product Due to Adverse Events | 7 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants Who Discontinued Investigational Product Due to Adverse Events | 7 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants Who Discontinued Investigational Product Due to Adverse Events | 15 Percentage of participants |
Secondary
Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Induction Phase
AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented.
Time frame: Up to Week 24
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK1265744 10 mg | Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Induction Phase | 0 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Induction Phase | 2 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Induction Phase | 5 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Induction Phase | 13 Percentage of participants |
Secondary
Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Maintenance Phase
AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented.
Time frame: Week 24 to Week 96
Population: Maintenance Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK1265744 10 mg | Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Maintenance Phase | 2 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Maintenance Phase | 4 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Maintenance Phase | 2 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Maintenance Phase | 2 Percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 16 and Week 24 Using MSDF Algorithm-Induction Phase
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA \<50 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population.
Time frame: Week 16 and Week 24
Population: ITT-E Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1265744 10 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 16 and Week 24 Using MSDF Algorithm-Induction Phase | Week 16 | 90 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 16 and Week 24 Using MSDF Algorithm-Induction Phase | Week 24 | 87 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 16 and Week 24 Using MSDF Algorithm-Induction Phase | Week 24 | 85 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 16 and Week 24 Using MSDF Algorithm-Induction Phase | Week 16 | 83 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 16 and Week 24 Using MSDF Algorithm-Induction Phase | Week 16 | 87 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 16 and Week 24 Using MSDF Algorithm-Induction Phase | Week 24 | 87 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 16 and Week 24 Using MSDF Algorithm-Induction Phase | Week 16 | 74 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 16 and Week 24 Using MSDF Algorithm-Induction Phase | Week 24 | 74 Percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase
Plasma samples were collected for quantitative analysis of HIV-1 RNA. The end point was determined using MSDF algorithm based on the current US FDA definition of Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. ITT-Maintenance Exposed (ME) Population comprised of all participants randomized to GSK1265744 and who received at least one dose of investigational product during maintenance phase of the study.
Time frame: Weeks 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Population: ITT-ME Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1265744 10 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 24 | 96 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 32 | 96 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 60 | 90 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 26 | 90 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 48 | 92 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 36 | 98 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 28 | 98 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 96 | 79 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 84 | 83 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 40 | 96 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 72 | 83 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 40 | 92 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 72 | 83 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 48 | 91 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 60 | 83 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 28 | 89 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 96 | 85 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 32 | 91 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 84 | 85 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 36 | 92 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 26 | 85 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 24 | 94 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 84 | 95 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 24 | 96 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 26 | 95 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 28 | 95 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 32 | 96 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 36 | 95 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 40 | 95 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 48 | 96 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 60 | 95 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 72 | 95 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 96 | 93 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 40 | 89 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 96 | 83 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 72 | 89 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 36 | 94 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 32 | 91 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 28 | 91 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 84 | 89 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 26 | 87 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 24 | 96 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 60 | 89 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase | Week 48 | 94 Percentage of participants |
Secondary
Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm
Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with HIV-1 RNA \<400 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population.
Time frame: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Population: ITT-E Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 26 | 80 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 24 | 93 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 12 | 90 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 96 | 75 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 16 | 93 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 84 | 77 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 72 | 77 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 2 | 87 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Baseline | 0 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 60 | 80 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 48 | 83 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 4 | 93 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 40 | 87 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 36 | 87 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 32 | 87 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 8 | 93 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 28 | 85 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 8 | 92 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Baseline | 0 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 2 | 80 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 4 | 93 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 12 | 85 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 16 | 87 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 24 | 87 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 26 | 80 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 28 | 83 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 32 | 85 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 36 | 85 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 40 | 85 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 48 | 85 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 60 | 77 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 72 | 75 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 84 | 77 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 96 | 77 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 96 | 85 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 2 | 84 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 36 | 90 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 60 | 87 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Baseline | 0 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 12 | 89 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 84 | 85 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 16 | 93 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 40 | 90 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 32 | 89 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 28 | 85 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 24 | 92 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 4 | 93 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 8 | 92 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 72 | 85 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 48 | 89 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 26 | 87 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 48 | 73 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 28 | 73 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 4 | 68 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 32 | 73 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 36 | 73 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 40 | 73 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 2 | 68 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 84 | 68 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 72 | 68 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 12 | 73 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 60 | 71 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Baseline | 0 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 16 | 81 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 8 | 79 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 96 | 65 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 24 | 79 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm | Week 26 | 71 Percentage of participants |
Secondary
Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA \<400 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on randomized therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period.
Time frame: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 36; n=52, 53, 55, 45 | 100 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 2; n=57, 56, 59, 59 | 91 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 32; n=52, 53, 55, 45 | 100 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 16; n=57, 54, 57, 52 | 98 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 28; n=51, 52, 52, 45 | 100 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 40; n=52, 53, 55, 45 | 100 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 72; n=47, 48, 52, 42 | 98 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 20; n=56, 54, 56, 47 | 100 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 8; n=59, 56, 57, 55 | 95 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Baseline; n=60, 60, 61, 62 | 0 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 48; n=51, 53, 54, 44 | 98 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 24; n=56, 53, 56, 48 | 100 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 84; n=46, 48, 52, 42 | 100 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 96; n=45, 48, 52, 40 | 96 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 60; n=48, 48, 53, 44 | 96 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 26; n=48, 50, 53, 44 | 100 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 12; n=58, 52, 57, 51 | 97 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 4; n=58, 57, 59, 57 | 97 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 12; n=58, 52, 57, 51 | 100 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 28; n=51, 52, 52, 45 | 100 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 4; n=58, 57, 59, 57 | 98 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 32; n=52, 53, 55, 45 | 100 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 40; n=52, 53, 55, 45 | 100 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 36; n=52, 53, 55, 45 | 100 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 84; n=46, 48, 52, 42 | 98 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 8; n=59, 56, 57, 55 | 98 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 96; n=45, 48, 52, 40 | 100 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 48; n=51, 53, 54, 44 | 98 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 72; n=47, 48, 52, 42 | 96 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 16; n=57, 54, 57, 52 | 100 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 2; n=57, 56, 59, 59 | 86 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 20; n=56, 54, 56, 47 | 100 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Baseline; n=60, 60, 61, 62 | 0 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 60; n=48, 48, 53, 44 | 100 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 24; n=56, 53, 56, 48 | 100 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 26; n=48, 50, 53, 44 | 100 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 72; n=47, 48, 52, 42 | 100 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Baseline; n=60, 60, 61, 62 | 0 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 2; n=57, 56, 59, 59 | 86 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 4; n=58, 57, 59, 57 | 97 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 8; n=59, 56, 57, 55 | 98 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 12; n=58, 52, 57, 51 | 98 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 16; n=57, 54, 57, 52 | 100 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 20; n=56, 54, 56, 47 | 100 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 24; n=56, 53, 56, 48 | 100 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 26; n=48, 50, 53, 44 | 100 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 28; n=51, 52, 52, 45 | 100 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 32; n=52, 53, 55, 45 | 98 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 36; n=52, 53, 55, 45 | 100 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 40; n=52, 53, 55, 45 | 100 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 48; n=51, 53, 54, 44 | 100 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 60; n=48, 48, 53, 44 | 100 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 84; n=46, 48, 52, 42 | 100 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 96; n=45, 48, 52, 40 | 100 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 26; n=48, 50, 53, 44 | 100 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 2; n=57, 56, 59, 59 | 71 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 48; n=51, 53, 54, 44 | 100 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 24; n=56, 53, 56, 48 | 100 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 20; n=56, 54, 56, 47 | 100 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Baseline; n=60, 60, 61, 62 | 0 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 16; n=57, 54, 57, 52 | 96 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 12; n=58, 52, 57, 51 | 92 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 60; n=48, 48, 53, 44 | 98 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 72; n=47, 48, 52, 42 | 100 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 8; n=59, 56, 57, 55 | 91 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 4; n=58, 57, 59, 57 | 74 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 96; n=45, 48, 52, 40 | 100 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 36; n=52, 53, 55, 45 | 100 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 32; n=52, 53, 55, 45 | 100 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 84; n=46, 48, 52, 42 | 100 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 40; n=52, 53, 55, 45 | 100 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis | Week 28; n=51, 52, 52, 45 | 100 Percentage of participants |
Secondary
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA \<50 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period or open-label phase.
Time frame: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Population: ITT-E Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 96; n=45, 48, 52, 40 | 89 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 72; n=47, 48, 52, 42 | 91 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 24; n=56, 53, 56, 48 | 93 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 288; n=30, 38, 45, 0 | 100 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 60; n=48, 48, 53, 44 | 94 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 48; n=51, 53, 54, 44 | 92 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 26; n=48, 50, 53, 44 | 98 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 108; n=43, 46, 49, 0 | 95 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 40; n=52, 53, 55, 45 | 96 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 36; n=52, 53, 55, 45 | 98 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 28; n=51, 52, 52, 45 | 100 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Baseline; n=60, 60, 61, 62 | 0 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 32; n=52, 53, 55, 45 | 96 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 312; n=31, 33, 43, 0 | 100 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 264; n=32, 38, 47, 0 | 100 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 252; n=31, 38, 47, 0 | 100 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 2; n=57, 56, 59, 59 | 51 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 300; n=31, 37, 44, 0 | 97 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 240; n=31, 39, 45, 0 | 97 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 228; n=32, 39, 47, 0 | 100 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 4; n=58, 57, 59, 57 | 83 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 168; n=35, 43, 47, 0 | 94 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 216; n=33, 39, 47, 0 | 100 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 204; n=34, 39, 47, 0 | 97 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 8; n=59, 56, 57, 55 | 92 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 324; n=3, 4, 3, 0 | 100 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 192; n=36, 40, 47, 0 | 94 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 180; n=36, 41, 47, 0 | 97 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 12; n=58, 52, 57, 51 | 95 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 276; n=31, 38, 45, 0 | 100 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 156; n=37, 42, 49, 0 | 95 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 16; n=57, 54, 57, 52 | 95 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 144; n=37, 45, 47, 0 | 92 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 132; n=40, 46, 49, 0 | 95 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 120; n=41, 46, 49, 0 | 95 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 20; n=56, 54, 56, 47 | 91 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 84; n=46, 48, 52, 42 | 91 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 16; n=57, 54, 57, 52 | 94 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 204; n=34, 39, 47, 0 | 97 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 264; n=32, 38, 47, 0 | 100 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 300; n=31, 37, 44, 0 | 100 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Baseline; n=60, 60, 61, 62 | 0 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 2; n=57, 56, 59, 59 | 54 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 4; n=58, 57, 59, 57 | 82 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 8; n=59, 56, 57, 55 | 89 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 12; n=58, 52, 57, 51 | 88 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 20; n=56, 54, 56, 47 | 98 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 24; n=56, 53, 56, 48 | 98 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 26; n=48, 50, 53, 44 | 94 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 28; n=51, 52, 52, 45 | 94 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 32; n=52, 53, 55, 45 | 94 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 36; n=52, 53, 55, 45 | 96 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 40; n=52, 53, 55, 45 | 96 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 48; n=51, 53, 54, 44 | 92 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 60; n=48, 48, 53, 44 | 96 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 72; n=47, 48, 52, 42 | 92 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 84; n=46, 48, 52, 42 | 94 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 96; n=45, 48, 52, 40 | 98 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 108; n=43, 46, 49, 0 | 96 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 120; n=41, 46, 49, 0 | 100 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 132; n=40, 46, 49, 0 | 96 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 144; n=37, 45, 47, 0 | 93 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 156; n=37, 42, 49, 0 | 95 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 168; n=35, 43, 47, 0 | 95 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 180; n=36, 41, 47, 0 | 100 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 192; n=36, 40, 47, 0 | 100 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 216; n=33, 39, 47, 0 | 100 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 228; n=32, 39, 47, 0 | 100 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 240; n=31, 39, 45, 0 | 97 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 252; n=31, 38, 47, 0 | 97 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 276; n=31, 38, 45, 0 | 100 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 288; n=30, 38, 45, 0 | 100 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 312; n=31, 33, 43, 0 | 97 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 324; n=3, 4, 3, 0 | 100 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 300; n=31, 37, 44, 0 | 95 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 16; n=57, 54, 57, 52 | 93 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 26; n=48, 50, 53, 44 | 98 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 228; n=32, 39, 47, 0 | 98 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 40; n=52, 53, 55, 45 | 95 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 264; n=32, 38, 47, 0 | 98 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 132; n=40, 46, 49, 0 | 100 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 2; n=57, 56, 59, 59 | 53 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 48; n=51, 53, 54, 44 | 98 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 324; n=3, 4, 3, 0 | 100 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 24; n=56, 53, 56, 48 | 95 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 108; n=43, 46, 49, 0 | 100 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 60; n=48, 48, 53, 44 | 98 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 204; n=34, 39, 47, 0 | 98 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 12; n=58, 52, 57, 51 | 91 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 240; n=31, 39, 45, 0 | 100 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 72; n=47, 48, 52, 42 | 100 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 312; n=31, 33, 43, 0 | 100 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 156; n=37, 42, 49, 0 | 98 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 276; n=31, 38, 45, 0 | 96 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 168; n=35, 43, 47, 0 | 98 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 96; n=45, 48, 52, 40 | 98 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 36; n=52, 53, 55, 45 | 95 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 180; n=36, 41, 47, 0 | 98 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 8; n=59, 56, 57, 55 | 93 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 288; n=30, 38, 45, 0 | 100 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 192; n=36, 40, 47, 0 | 96 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 84; n=46, 48, 52, 42 | 100 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 4; n=58, 57, 59, 57 | 73 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 144; n=37, 45, 47, 0 | 98 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 216; n=33, 39, 47, 0 | 98 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 252; n=31, 38, 47, 0 | 98 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 28; n=51, 52, 52, 45 | 100 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 20; n=56, 54, 56, 47 | 98 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 32; n=52, 53, 55, 45 | 96 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Baseline; n=60, 60, 61, 62 | 0 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 120; n=41, 46, 49, 0 | 98 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 72; n=47, 48, 52, 42 | 100 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 84; n=46, 48, 52, 42 | 100 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 96; n=45, 48, 52, 40 | 98 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 16; n=57, 54, 57, 52 | 87 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 12; n=58, 52, 57, 51 | 76 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 8; n=59, 56, 57, 55 | 55 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 4; n=58, 57, 59, 57 | 26 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 28; n=51, 52, 52, 45 | 96 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 2; n=57, 56, 59, 59 | 14 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 32; n=52, 53, 55, 45 | 96 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 26; n=48, 50, 53, 44 | 93 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 36; n=52, 53, 55, 45 | 98 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 40; n=52, 53, 55, 45 | 93 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 24; n=56, 53, 56, 48 | 96 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 48; n=51, 53, 54, 44 | 98 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 60; n=48, 48, 53, 44 | 95 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Week 20; n=56, 54, 56, 47 | 91 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis | Baseline; n=60, 60, 61, 62 | 0 Percentage of participants |
Secondary
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA \<50 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population.
Time frame: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312
Population: ITT-E Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 228 | 53 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 108 | 68 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 32 | 83 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 312 | 52 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 96 | 68 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 84 | 72 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 36 | 85 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 264 | 53 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 72 | 72 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 60 | 78 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 40 | 83 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 252 | 52 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 48 | 80 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 8 | 90 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 300 | 52 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 240 | 50 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 216 | 55 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 12 | 88 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 2 | 48 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 204 | 55 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 192 | 57 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 16 | 90 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Baseline | 0 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 180 | 58 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 168 | 57 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 24 | 87 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 288 | 50 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 156 | 58 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 144 | 58 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 26 | 78 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 276 | 52 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 132 | 62 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 120 | 65 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 28 | 85 Percentage of participants |
| GSK1265744 10 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 4 | 80 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 108 | 72 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Baseline | 0 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 2 | 50 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 4 | 78 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 8 | 83 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 12 | 75 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 16 | 83 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 24 | 85 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 26 | 75 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 28 | 78 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 32 | 80 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 36 | 82 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 40 | 82 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 48 | 80 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 60 | 73 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 72 | 73 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 84 | 75 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 96 | 75 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 120 | 73 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 132 | 70 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 144 | 67 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 156 | 63 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 168 | 65 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 180 | 67 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 192 | 65 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 204 | 62 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 216 | 63 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 228 | 63 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 240 | 62 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 252 | 62 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 264 | 62 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 276 | 62 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 288 | 62 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 300 | 60 Percentage of participants |
| GSK1265744 30 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 312 | 52 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 132 | 80 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 108 | 80 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 216 | 77 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 26 | 85 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 168 | 75 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 228 | 75 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Baseline | 0 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 8 | 87 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 312 | 70 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 240 | 74 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 16 | 87 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 2 | 51 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 300 | 70 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 180 | 75 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 40 | 85 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 252 | 75 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 48 | 87 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 144 | 77 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 120 | 80 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 24 | 87 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 60 | 85 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 192 | 74 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 36 | 85 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 4 | 70 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 72 | 85 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 276 | 70 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 12 | 82 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 288 | 74 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 84 | 85 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 204 | 75 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 32 | 87 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 264 | 75 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 96 | 84 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 156 | 80 Percentage of participants |
| GSK1265744 60 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 28 | 85 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 28 | 69 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 108 | 0 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 26 | 66 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 264 | 0 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 120 | 0 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 2 | 13 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 132 | 0 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 24 | 74 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 144 | 0 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 156 | 0 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 16 | 74 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 276 | 0 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 168 | 0 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 180 | 0 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 12 | 61 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 312 | 0 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 192 | 0 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 204 | 0 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 8 | 48 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 288 | 0 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 216 | 0 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Baseline | 0 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 228 | 0 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 240 | 0 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 4 | 24 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 40 | 68 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 48 | 71 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 36 | 71 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 252 | 0 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 60 | 68 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 72 | 68 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 32 | 69 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 300 | 0 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 84 | 68 Percentage of participants |
| Efavirenz 600 mg | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm | Week 96 | 63 Percentage of participants |