HIV Infections
Conditions
Keywords
integrase inhibitor, non-inferiority, dolutegravir, lopinavir/ritonavir, second-line treatment, HIV-1, antiretroviral therapy-experienced
Brief summary
For treatment of human immunodeficiency virus type 1(HIV-1), publicly funded programmes tend to follow World Health Organization (WHO) guidelines to use a non-nucleoside reverse transcriptase inhibitor (NNRTI) combined with two nucleoside reverse transcriptase inhibitors (NRTIs) for first-line antiretroviral therapy (ART); however, there is a need for further data on the best treatment options for people with HIV-1 who have virological failure with this first-line regimen. The number of patients failing on their first-line regimen is increasing thereby requiring a switch to second-line treatment to reduce accumulation of drug-resistance mutations, disease progression, HIV transmission, and death. WHO guidelines recommend second-line antiretroviral therapy for adults consisting of two NRTIs + a ritonavir-boosted protease inhibitor (PI); atazanavir (ATV) plus ritonavir (RTV) or lopinavir (LPV)/RTV are the preferred boosted PI options. This study is conducted to demonstrate non-inferior antiviral activity at 48 weeks of a dolutegravir (DTG) containing regimen compared to a WHO-recommended standard of care regimen for second line treatment, LPV/RTV + two NRTIs, in HIV-1 infected patients failing first line therapy. This study comprises of a Screening Phase (approximately 28 to 42 days), a Randomized Phase (Day 1 to Week 48 plus a 4-week treatment extension), and a Continuation Phase. Approximately 612 subjects will be randomized 1:1 to receive DTG 50 milligram (mg) once daily or LPV/RTV (800/200 mg once daily or 400/100 mg twice daily, in accordance with investigator decision and local label), each added to an investigator selected background regimen of two NRTIs at least one of which needs to be fully active based on viral resistance testing at Screening. Subjects randomized to the LPV/RTV arm will either (i) continue receiving LPV/RTV and complete the study after the 4-week treatment extension at Week 52, or (ii) switch to the DTG arm prior to study completion at Week 52 and continue to have access to DTG in the Continuation Phase. Subjects randomized to receive DTG who successfully complete 52 weeks of treatment and subjects originally randomized to receive LPV/RTV but switched to DTG prior to Week 52 will continue to have access to DTG until it is either locally approved and commercial supplies are available to patients or the patient no longer derives clinical benefit, or the patient meets a protocol-defined reason for discontinuation.
Interventions
DRUGDTG
DTG is supplied as 50 mg tablets
DRUGLPV/RTV
LPV/RTV is supplied as the LPV/RTV oral tablet, which contains 200 mg of LPV and 50 mg of RTV
DRUGTwo NRTIs
Investigators will choose a dual NRTI background regimen for each subject . In consultation with the medical monitor, 3TC may be added as a third NRTI to a dual-NRTI background regimen in subjects with chronic HBV infection and evidence of HIV resistance to 3TC
Sponsors
GlaxoSmithKline
ViiV Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HIV-1 infected subjects \>=18 years of age. * A female subject may be eligible to enter and participate in the study if she: is of non-childbearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and \>=45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy, or bilateral oophorectomy or, is of child-bearing potential, with a negative pregnancy test at both Screening and Day 1 and agrees to use one of the protocol-defined methods of contraception to avoid pregnancy throughout the study and for at least 2 weeks after discontinuation of all study medication. * HIV-1 infection as documented by HIV-1 RNA \>=400 c/mL at Screening. * Subject has been on a first-line treatment regimen consisting of an NNRTI plus two NRTIs for at least 6 months and is currently experiencing virologic failure to this first-line regimen defined as two consecutive (\>=7 days apart) HIV-1 RNA results of \>=400 c/mL. * Subjects must receive at least one fully active agent within the dual-NRTI background regimen for second line treatment. Fully active is defined by the Screening genotypic resistance report of the central laboratory (or a laboratory contracted by the central laboratory) showing no evidence of full or of partial resistance for a given NRTI which will be taken on study. * Subject is PI-naïve and Integrase inhibitor (INI)-naïve, defined as no prior or current exposure to any PI or INI. * Subject or the subject's legal representative is willing and able to understand and provide signed and dated written informed consent prior to screening.
Exclusion criteria
* Women who are breastfeeding. * Any evidence of an active Centers for Disease Control and Prevention (CDC) Category C disease Exceptions include cutaneous Kaposi's sarcoma not requiring systemic therapy and historic or current CD4+ cell levels \<200 cells per cubic millimeter * Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification * Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). * Anticipated need for hepatitis C virus (HCV) therapy during the Randomized Phase of the study. * History or presence of allergy or intolerance to the study drugs or their components or drugs of their class. * Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the subject. * Subjects who in the investigator's judgment, poses a significant suicidality risk. Recent history of suicidal behavior and/or suicidal ideation may be considered as evidence of serious suicide risk. * Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening. * Treatment with any of the following agents within 28 days of Screening: radiation therapy, cytotoxic chemotherapeutic agents, systemically administered immunomodulators. * Treatment with any agent, other than licensed ART as allowed above with documented activity against HIV-1 in vitro/vivo within 28 days of first dose of IP. The exception is use of entecavir, in appropriate clinical situations, for treatment of hepatitis B \[e.g. prior intolerance to Tenofovir (TDF), viral resistance to lamivudine (3TC) / Emtricitabine (FTC)\] after discussion and agreement between the investigator and the medical monitor. * Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of IP. * Any evidence of primary viral resistance to PIs or INIs based on the presence of any major resistance-associated mutation. * The subject's virus does not yield results using genotype at Screening (assay data is essential for eligibility determination). * Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 triglycerides. A single repeat test is allowed during the Screening period to verify a result. * Any acute laboratory abnormality at Screening, which, in the opinion of the Investigator, would preclude the subject's participation in the study of an investigational compound. * Alanine aminotransferase (ALT) \>=5 times the upper limit of normal (ULN) or ALT \>=3xULN and bilirubin \>=1.5xULN (with \>35% direct bilirubin)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <50 Copies Per Milliliter (c/mL) at Week 48 | Week 48 | Percentage of participants with plasma HIV 1 RNA \<50 c/mL at Week 48 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to demonstrate the non-inferior activity of DTG plus 2 NRTI's compared to LPV/RTV plus 2 NRTI's. Analysis was performed on Intent-to-treat exposed (ITT-E) Population, which comprised of all randomized participants who received at least one dose of study medication. Percentage values are rounded off. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Plasma HIV-1 RNA <400 c/mL at Weeks 24 and 48 | Week 24 and Week 48 | Percentage of participants with plasma HIV 1 RNA \<400 c/mL at Week 24 and 48 using the FDA snapshot algorithm were evaluated. Percentage values are rounded off. |
| Percentage of Participants Without Virologic or Tolerability Failure at Week 24 and Week 48 | Week 24 and Week 48 | Virologic or tolerability failure was defined as treatment-related discontinuation (meeting confirmed virologic withdrawal criteria, treatment-related adverse event, safety stopping criteria, and lack of efficacy). Percentage of participants without virologic failure by Week 24 and Week 48 have been presented. Participants who did not met the protocol defined confirmed virologic withdrawal criteria and are ongoing in the study, or who had discontinued for non-treatment related reasons were censored. |
| Time to Viral Suppression at Week 48 | Week 48 | Viral suppression was defined as HIV-1 RNA \<50 c/mL. Time to viral suppression was analyzed and median and interquartile range has been presented. |
| Change From Baseline in Helper-inducer T-lymphocyte Having Surface Antigen Cluster of Differentiation (CD4+) Cell Count at Weeks 24 and 48 | Baseline (Day 1, Pre-dose), Week 24 and Week 48 | Blood was collected and CD4+ cell count assessment was carried out at indicated time points to evaluate the immunological activity of DTG compared to LPV/RTV. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Number of Participants With Disease Progression-Randomized + Continuation Phase | Up to Week 348 | Disease progression included HIV-associated conditions, acquired immune deficiency syndrome (AIDS) and death. Number of participants with disease progression to Centers for Disease Control and Prevention (CDC) class C or death have been presented. |
| Number of Participants With Treatment-emergent Genotypic Resistance-Randomized Phase | Up to Week 52 | Number of participants, who met confirmed virologic withdrawal (CVW) criteria with paired Baseline and time of CVW resistance data with treatment emergent genotypic resistance to Integrase strand transfer inhibitor (INSTI), NRTI, Protease inhibitor (PI) were summarized. Viral Genotypic Population comprised of all participants in the ITT-E population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met during Randomized Phase. |
| Number of Participants With Treatment-emergent Genotypic Resistance-Continuation Phase | Up to Week 295 | Number of participants, who met confirmed virologic withdrawal criteria with paired Baseline and time of CVW resistance data, with treatment emergent genotypic resistance to Integrase strand transfer inhibitor (INSTI), NRTI, Protease inhibitor (PI) were summarized. Analysis was performed on Viral Genotypic Continuation Population which comprised all participants in the ITT-E- Continuation Population with available on-treatment genotypic resistance data in the Continuation Phase. |
| Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase | Baseline (Day 1, Pre-dose) and up to Week 52 | Number of participants with fold change in treatment-emergent phenotypic resistance from Baseline to DTG, LPV/RTV was counted to assess the development of viral resistance. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Change in grade 0 to \>2 from Baseline is presented. Analysis was performed on viral phenotypic Population, which comprised of all participants in the ITT-E Population with available On-treatment phenotypic resistance data at the time confirmed virologic withdrawal criterion is met during Randomized Phase. |
| Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Continuation Phase | Baseline (Day 1, Pre-dose) and up to Week 295 | Number of participants with fold change in treatment-emergent phenotypic resistance from Baseline to DTG was counted to assess the development of viral resistance. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Change in grade 0 to \>2 from Baseline is presented. Analysis was performed on Viral Phenotypic Continuation Population which comprises all participants in the ITT-E- Continuation Population with available on-treatment phenotypic resistance data in the Continuation Phase. |
| Number of Participants With Non-serious Adverse Events (AEs) With >=2% Frequency Threshold and Serious Adverse Events (SAEs)-Randomized Phase | Up to Week 52 | An AE is 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. SAE is defined as 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, or is a congenital anomaly/birth defect, other situations as per medical or scientific judgment and is associated with liver injury or impaired liver function. Safety Population was used which comprised of all participants who received at least one dose of study treatment. Adverse events which were not Serious were considered as Non-Serious adverse events. |
| Number of Participants With Non-serious AEs With >=2% Frequency Threshold and SAEs-Continuation Phase | Up to Week 295 | An AE is 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. SAE is defined as 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, or is a congenital anomaly/birth defect, other situations as per medical or scientific judgment and is associated with liver injury or impaired liver function. Adverse events which were not Serious were considered as non-serious AEs. |
| Number of Participants With Non-serious AEs With >=2% Frequency Threshold and SAEs-Randomized + Continuation Phase | Up to Week 348 | An AE is 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. SAE is defined as 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, or is a congenital anomaly/birth defect, other situations as per medical or scientific judgment and is associated with liver injury or impaired liver function. Adverse events which were not Serious were considered as non-serious AEs. |
| Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52 | Blood samples were collected from participants to evaluate clinical chemistry parameters including glucose, chloride, carbon-di-oxide (CO2), potassium, phosphate, sodium, urea, cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides. Lipid parameters were evaluated in fasting condition. Change from Baseline in clinical chemistry parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. |
| Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52 | Blood samples were collected from participants to evaluate clinical chemistry parameters including ALP, ALT, AST and creatine kinase. Change from Baseline in clinical chemistry parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. |
| Change From Baseline in Albumin Values | Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52 | Blood samples were collected from participants to evaluate clinical chemistry parameter including albumin. Change from Baseline in clinical chemistry parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. |
| Change From Baseline in Creatinine and Bilirubin Values | Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52 | Blood samples were collected from participants to evaluate clinical chemistry parameters including creatinine and bilirubin. Change from Baseline in clinical chemistry parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. |
| Change From Baseline in Lipase Values | Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52 | Blood samples were collected from participants to evaluate clinical chemistry parameter including lipase. Change from Baseline in lipase at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. |
| Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24 | Week 24 | Percentage of participants with plasma HIV 1 RNA \<50 c/mL at Week 24 using the FDA snapshot algorithm was assessed to demonstrate the non-inferior activity of DTG plus 2 NRTI's compared to LPV/RTV plus 2 NRTI's. Percentage values are rounded off. |
| Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Up to Week 295 | Number of participants with clinical chemistry toxicities has been presented. Toxicities were based on the Division of AIDS (DAIDS) grading system. Grade 1=Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Potentially life-threatening. Higher the grade, more severe the symptoms. Lipids and glucose parameters were summarized on fasting data. Data has been reported for clinical chemistry parameters including serum glucose, ALT, Albumin, ALP, AST, Bilirubin, CO2, Creatine kinase, LDL cholesterol calculation, LDL cholesterol direct, Lipase, Phosphate, Potassium, Sodium, Cholesterol, Creatinine and Serum Triglycerides. |
| Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52 | Blood samples were collected from participants to evaluate clinical hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Change from Baseline in clinical hematology parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. |
| Change From Baseline in Hematocrit Values | Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and and Week 52 | Blood samples were collected from participants to evaluate clinical hematology parameter including hematocrit. Change from Baseline in hematocrit values at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. |
| Change From Baseline in Hemoglobin Values | Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52 | Blood samples were collected from participants to evaluate clinical hematology parameter including hemoglobin. Change from Baseline in hemoglobin values at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. |
| Change From Baseline in Mean Corpuscular Volume (MCV) | Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and and Week 52 | Blood samples were collected from participants to evaluate clinical hematology parameter including MCV. Change from Baseline in MCV values at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. |
| Change From Baseline in Erythrocyte Values | Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and up to Week 52 | Blood samples were collected from participants to evaluate clinical hematology parameter including erythrocyte. Change from Baseline in erythrocyte values at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. |
| Number of Participants With Hematology Toxicities -Randomized Phase | Up to Week 52 | Number of participants with hematology toxicities has been presented. Toxicities were based on the Division of AIDS (DAIDS) grading system. Grade 1=Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for hematology parameters including Hemoglobin, Leukocytes, Neutrophils and Platelets. |
| Number of Participants With Hematology Toxicities-Continuation Phase | Up to Week 295 | Number of participants with hematology toxicities has been presented. Toxicities were based on the Division of AIDS (DAIDS) grading system. Grade 1=Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for hematology parameters including Hemoglobin, Leukocytes, Neutrophils and Platelets. |
| Number of Participants Who Discontinued Treatment Due to AEs-Randomized Phase | Up to Week 52 | Number of participants who discontinued study treatment due to AEs or SAEs were summarized. |
| Number of Participants Who Discontinued Treatment Due to AEs-Continuation Phase | Up to Week 295 | Number of participants who discontinued study treatment due to AEs were summarized. |
| Change From Baseline in Fasting LDL Cholesterol at Week 24 and Week 48 | Baseline (Day 1, Pre-dose), Week 24 and Week 48 | Blood samples were collected from participants in fasting state to evaluate LDL cholesterol. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Analysis was performed using multiple imputation with missing at random assumption. Only participants available at the time of evaluation were analyzed. |
| Change From Baseline in Fasting Total Cholesterol/HDL Cholesterol Ratio | Baseline (Day 1, Pre-dose), Week 24 and Week 48 | Blood samples were collected from participants in fasting state to evaluate total cholesterol/HDL cholesterol ratio. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Only participants available at the time of evaluation were analyzed. Analysis was performed using multiple imputation with missing at random assumption. |
| Number of Participants With Maximum Post-Baseline Emergent Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol | Up to Week 48 | Blood samples were collected from participants in fasting state at indicated time-points to evaluate LDL cholesterol. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Number of participants who experienced maximum grade 2 or greater toxicity post-Baseline in fasting LDL cholesterol was summarized. Participants were graded using the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening. Higher the grade, more severe the symptoms. |
| Number of Participants With Maximum Post-Baseline Emergent Grade 2 or Greater Drug-related Diarrhea | Week 24 and Week 48 | Number of participants who experienced maximum grade 2 or greater toxicity post-Baseline in drug-related diarrhea was summarized. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Participants were graded using the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening. Higher the grade, more severe the symptoms. |
| Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score | Baseline (Day 1, Pre-dose), Week 4, Week 24, Week 48 | The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea and Constipation. The scale ranges from 1= no discomfort to 7= very severe discomfort for each symptom cluster. Higher scores show greater severity of symptoms. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. The analysis was performed using Last Observation Carried Forward (LOCF) dataset. In the LOCF dataset, missing values were carried forward from the previous, non-missing available on-treatment assessment. |
| Change From Baseline in Treatment Satisfaction, Using the HIV-Treatment Satisfaction Questionnaire (HIVTSQ) Score | Baseline (Day 1, Pre-dose), Week 4, Week 24, Week 48 | The HIVTSQ is a self-reported scales that measure overall satisfaction with treatment. The score ranges from 0-10. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. The analysis was performed using LOCF dataset. In the LOCF dataset, missing values were carried forward from the previous, non-missing available on-treatment assessment. |
| Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) | Baseline (Day 1, Pre-dose), Week 4, Week 24 and Week 48 | Treatment compliance was evaluated through MMAS-8. It is an eight-item self-reported measure of medication-taking behavior. The score ranges from 0-8 where scores of 8 indicate high or near perfect adherence, and scores of less than 6 indicate poor or inadequate adherence on the MMAS-8 scale. Number of participants showing low, medium and high adherence to treatment are presented. Low adherence is a score 0-5.75, medium adherence is a score of 6-7.75 and high adherence is a score of 8. The analysis was performed using LOCF dataset. In the LOCF dataset, missing values were carried forward from the previous, non-missing available on-treatment assessment. |
| Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Up to Week 52 | Number of participants with clinical chemistry toxicities has been presented. Toxicities were based on the Division of AIDS (DAIDS) grading system. Grade 1=Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Potentially life-threatening. Higher the grade, more severe the symptoms. Lipids and glucose parameters were summarized on fasting data. Data has been reported for clinical chemistry parameters including serum glucose, ALT, Albumin, ALP, AST, Bilirubin, CO2, Creatine kinase, LDL cholesterol calculation, LDL cholesterol direct, Lipase, Phosphate, Potassium, Sodium, Cholesterol, Creatinine and Serum Triglycerides. |
Countries
Argentina, Brazil, Chile, China, Colombia, Kenya, Mexico, Peru, Romania, Russia, South Africa, Thailand, Ukraine
Participant flow
Recruitment details
This study assessed antiviral activity and safety of dolutegravir (DTG) in human immunodeficiency virus-1 (HIV-1) infected participants with treatment failure on first line therapy. The study consisted of Randomized Phase followed by Continuation Phase.
Pre-assignment details
A total of 627 participants were randomized in 1:1 to receive DTG or lopinavir/ritonavir (LPV/RTV). Three participants in the LPV/RTV group were randomized but not treated. A total of 624 participants received at least one dose of study medication creating the intent to treat-exposed (ITT-E) Population.
Participants by arm
| Arm | Count |
|---|---|
| Participants Receiving DTG-Randomized Phase Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase. | 312 |
| Participants Receiving LPV/RTV-Randomized Phase Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase. | 312 |
| Total | 624 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Continuation Phase(From Weeks 52 to 295) | Adverse Event | 0 | 0 | 8 |
| Continuation Phase(From Weeks 52 to 295) | Lack of Efficacy | 0 | 0 | 16 |
| Continuation Phase(From Weeks 52 to 295) | Lost to Follow-up | 0 | 0 | 7 |
| Continuation Phase(From Weeks 52 to 295) | Physician Decision | 0 | 0 | 4 |
| Continuation Phase(From Weeks 52 to 295) | Protocol Violation | 0 | 0 | 8 |
| Continuation Phase(From Weeks 52 to 295) | Withdrawal by Subject | 0 | 0 | 6 |
| Randomized Phase (Up to Week 52) | Adverse Event | 8 | 18 | 0 |
| Randomized Phase (Up to Week 52) | Lack of Efficacy | 10 | 22 | 0 |
| Randomized Phase (Up to Week 52) | Lost to Follow-up | 7 | 5 | 0 |
| Randomized Phase (Up to Week 52) | Physician Decision | 0 | 9 | 0 |
| Randomized Phase (Up to Week 52) | Protocol Violation | 7 | 8 | 0 |
| Randomized Phase (Up to Week 52) | Randomized, but did not receive treatment | 0 | 3 | 0 |
| Randomized Phase (Up to Week 52) | Reached stopping criteria | 0 | 1 | 0 |
| Randomized Phase (Up to Week 52) | Withdrawal by Subject | 5 | 4 | 0 |
Baseline characteristics
| Characteristic | Participants Receiving DTG-Randomized Phase | Participants Receiving LPV/RTV-Randomized Phase | Total |
|---|---|---|---|
| Age, Continuous | 37.5 Years STANDARD_DEVIATION 9.13 | 38.7 Years STANDARD_DEVIATION 9.35 | 38.1 Years STANDARD_DEVIATION 9.25 |
| Race/Ethnicity, Customized Race, customized American Indian or Alaska native | 42 Participants | 53 Participants | 95 Participants |
| Race/Ethnicity, Customized Race, customized Asian- Central/South Asian Heritage | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race, customized Asian - East Asian Heritage | 21 Participants | 31 Participants | 52 Participants |
| Race/Ethnicity, Customized Race, customized Asian - South East Asian Heritage | 28 Participants | 25 Participants | 53 Participants |
| Race/Ethnicity, Customized Race, customized Black or African American Heritage | 130 Participants | 112 Participants | 242 Participants |
| Race/Ethnicity, Customized Race, customized Mixed White Race | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race, customized White - Arabic/North African Heritage | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race, customized White - White/Caucasian/European Heritage | 88 Participants | 90 Participants | 178 Participants |
| Sex: Female, Male Female | 116 Participants | 103 Participants | 219 Participants |
| Sex: Female, Male Male | 196 Participants | 209 Participants | 405 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 314 | 3 / 310 | 3 / 274 | 5 / 314 | 3 / 310 |
| other Total, other adverse events | 155 / 314 | 202 / 310 | 150 / 274 | 218 / 314 | 213 / 310 |
| serious Total, serious adverse events | 20 / 314 | 20 / 310 | 29 / 274 | 47 / 314 | 20 / 310 |
Outcome results
Primary
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <50 Copies Per Milliliter (c/mL) at Week 48
Percentage of participants with plasma HIV 1 RNA \<50 c/mL at Week 48 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to demonstrate the non-inferior activity of DTG plus 2 NRTI's compared to LPV/RTV plus 2 NRTI's. Analysis was performed on Intent-to-treat exposed (ITT-E) Population, which comprised of all randomized participants who received at least one dose of study medication. Percentage values are rounded off.
Time frame: Week 48
Population: ITT-E Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants Receiving DTG-Randomized Phase | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <50 Copies Per Milliliter (c/mL) at Week 48 | 84 Percentage of participants |
| Participants Receiving LPV/RTV-Randomized Phase | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <50 Copies Per Milliliter (c/mL) at Week 48 | 70 Percentage of participants |
p-value: <0.00195% CI: [7.3, 20.3]Cochran-Mantel-Haenszel
Secondary
Change From Baseline in Albumin Values
Blood samples were collected from participants to evaluate clinical chemistry parameter including albumin. Change from Baseline in clinical chemistry parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52
Population: Safety Population. Two participants who were randomized to receive LPV/RTV, received DTG and were included in DTG group for Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Albumin Values | Week 16; n= 294, 292 | 0.50 Gram per liter | Standard Deviation 3.148 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Albumin Values | Week 36; n= 289, 276 | 0.76 Gram per liter | Standard Deviation 3.479 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Albumin Values | Week 8; n= 301, 298 | 0.09 Gram per liter | Standard Deviation 2.792 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Albumin Values | Week 48; n= 278, 247 | 0.71 Gram per liter | Standard Deviation 3.25 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Albumin Values | Week 24; n= 295, 286 | 0.63 Gram per liter | Standard Deviation 3.326 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Albumin Values | Week 52; n= 276, 238 | 0.83 Gram per liter | Standard Deviation 3.605 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Albumin Values | Week 4; n= 306, 302 | -0.39 Gram per liter | Standard Deviation 2.554 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Albumin Values | Week 52; n= 276, 238 | -0.15 Gram per liter | Standard Deviation 3.142 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Albumin Values | Week 4; n= 306, 302 | -0.51 Gram per liter | Standard Deviation 2.67 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Albumin Values | Week 8; n= 301, 298 | -0.67 Gram per liter | Standard Deviation 2.828 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Albumin Values | Week 16; n= 294, 292 | -0.28 Gram per liter | Standard Deviation 3.062 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Albumin Values | Week 24; n= 295, 286 | -0.06 Gram per liter | Standard Deviation 3.207 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Albumin Values | Week 36; n= 289, 276 | -0.11 Gram per liter | Standard Deviation 3.091 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Albumin Values | Week 48; n= 278, 247 | 0.11 Gram per liter | Standard Deviation 2.912 |
Secondary
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values
Blood samples were collected from participants to evaluate clinical chemistry parameters including ALP, ALT, AST and creatine kinase. Change from Baseline in clinical chemistry parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52
Population: Safety Population. Two participants who were randomized to receive LPV/RTV, received DTG and were included in DTG group for Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | AST; Week 4; n= 306, 302 | -3.56 International unit per liter | Standard Deviation 17.463 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | ALP; Week 36; n= 289, 276 | -13.53 International unit per liter | Standard Deviation 28.875 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | AST; Week 8; n= 301, 297 | -2.89 International unit per liter | Standard Deviation 17.934 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | ALT; Week 8; n= 301, 298 | -2.49 International unit per liter | Standard Deviation 19.222 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | AST; Week 16; n= 294, 292 | -4.70 International unit per liter | Standard Deviation 17.445 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | ALP; Week 8; n= 301, 298 | -13.73 International unit per liter | Standard Deviation 26.135 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | AST; Week 24; n= 295, 286 | -3.83 International unit per liter | Standard Deviation 17.713 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | ALT; Week 16; n= 294, 292 | -4.32 International unit per liter | Standard Deviation 18.502 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | AST; Week 36; n= 289, 276 | -1.76 International unit per liter | Standard Deviation 22.437 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | ALP; Week 48; n= 278, 247 | -14.10 International unit per liter | Standard Deviation 28.935 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | AST; Week 48; n= 278, 247 | -2.03 International unit per liter | Standard Deviation 28.194 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | ALT; Week 24; n= 295, 286 | -3.87 International unit per liter | Standard Deviation 20.108 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | AST; Week 52; n= 276, 238 | -1.51 International unit per liter | Standard Deviation 22.645 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | ALP; Week 24; n= 295, 286 | -14.19 International unit per liter | Standard Deviation 27.8 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | Creatine kinase; Week 4; n= 306, 302 | -2.85 International unit per liter | Standard Deviation 215.82 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | ALT; Week 36; n= 289, 276 | -1.31 International unit per liter | Standard Deviation 25.356 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | Creatine kinase; Week 8; n= 301, 298 | 18.61 International unit per liter | Standard Deviation 312.94 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | ALP; Week 52; n= 276, 238 | -13.81 International unit per liter | Standard Deviation 29.317 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | Creatine kinase; Week 16; n= 294, 292 | 11.75 International unit per liter | Standard Deviation 180.905 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | ALT; Week 48; n= 278, 247 | 0.19 International unit per liter | Standard Deviation 39.985 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | Creatine kinase; Week 24; n= 295, 286 | 34.71 International unit per liter | Standard Deviation 312.173 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | ALP; Week 16; n= 294, 292 | -13.87 International unit per liter | Standard Deviation 31.452 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | Creatine kinase; Week 36; n= 289, 276 | 72.34 International unit per liter | Standard Deviation 892.83 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | ALT; Week 52; n= 276, 238 | -1.04 International unit per liter | Standard Deviation 23.232 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | Creatine kinase; Week 48; n= 278, 247 | 45.50 International unit per liter | Standard Deviation 451.135 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | ALT; Week 4; n= 306, 302 | -2.50 International unit per liter | Standard Deviation 17.285 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | Creatine kinase; Week 52; n= 276, 238 | 39.24 International unit per liter | Standard Deviation 228.026 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | ALP; Week 4; n= 306, 302 | -12.24 International unit per liter | Standard Deviation 21.9 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | Creatine kinase; Week 52; n= 276, 238 | 54.97 International unit per liter | Standard Deviation 628.621 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | ALP; Week 4; n= 306, 302 | -14.94 International unit per liter | Standard Deviation 22.979 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | ALP; Week 8; n= 301, 298 | -13.46 International unit per liter | Standard Deviation 29.998 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | ALP; Week 16; n= 294, 292 | -11.38 International unit per liter | Standard Deviation 26.19 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | ALP; Week 24; n= 295, 286 | -6.06 International unit per liter | Standard Deviation 50.943 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | ALP; Week 36; n= 289, 276 | -7.85 International unit per liter | Standard Deviation 30.394 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | ALP; Week 48; n= 278, 247 | -6.87 International unit per liter | Standard Deviation 32.071 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | ALP; Week 52; n= 276, 238 | -7.23 International unit per liter | Standard Deviation 31.046 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | ALT; Week 4; n= 306, 302 | -10.25 International unit per liter | Standard Deviation 17.639 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | ALT; Week 8; n= 301, 298 | -9.04 International unit per liter | Standard Deviation 25.556 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | ALT; Week 16; n= 294, 292 | -8.59 International unit per liter | Standard Deviation 24.507 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | ALT; Week 24; n= 295, 286 | -9.20 International unit per liter | Standard Deviation 33.054 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | ALT; Week 36; n= 289, 276 | -11.16 International unit per liter | Standard Deviation 22.196 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | ALT; Week 48; n= 278, 247 | -6.47 International unit per liter | Standard Deviation 51.492 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | ALT; Week 52; n= 276, 238 | -10.63 International unit per liter | Standard Deviation 25.508 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | AST; Week 4; n= 306, 302 | -7.68 International unit per liter | Standard Deviation 13.654 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | AST; Week 8; n= 301, 297 | -6.64 International unit per liter | Standard Deviation 21.295 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | AST; Week 16; n= 294, 292 | -6.49 International unit per liter | Standard Deviation 18.143 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | AST; Week 24; n= 295, 286 | -6.45 International unit per liter | Standard Deviation 28.933 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | AST; Week 36; n= 289, 276 | -8.36 International unit per liter | Standard Deviation 21.55 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | AST; Week 48; n= 278, 247 | -6.43 International unit per liter | Standard Deviation 27.155 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | AST; Week 52; n= 276, 238 | -7.55 International unit per liter | Standard Deviation 28.125 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | Creatine kinase; Week 4; n= 306, 302 | -15.59 International unit per liter | Standard Deviation 106.738 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | Creatine kinase; Week 8; n= 301, 298 | -10.42 International unit per liter | Standard Deviation 128.109 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | Creatine kinase; Week 16; n= 294, 292 | 11.62 International unit per liter | Standard Deviation 203.66 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | Creatine kinase; Week 24; n= 295, 286 | -0.28 International unit per liter | Standard Deviation 186.927 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | Creatine kinase; Week 36; n= 289, 276 | -5.08 International unit per liter | Standard Deviation 135.191 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values | Creatine kinase; Week 48; n= 278, 247 | 16.52 International unit per liter | Standard Deviation 295.891 |
Secondary
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Blood samples were collected from participants to evaluate clinical hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Change from Baseline in clinical hematology parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52
Population: Safety Population. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophil; Week 16; n= 286, 286 | 0.00 10^9 cells/liter | Standard Deviation 0.017 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocyte; Week 36; n= 283, 275 | 0.01 10^9 cells/liter | Standard Deviation 0.151 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophil; Week 52; n= 265, 229 | 0.02 10^9 cells/liter | Standard Deviation 0.188 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocyte; Week 48; n= 266, 242 | 0.01 10^9 cells/liter | Standard Deviation 0.157 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophil; Week 4; n= 290, 291 | 0.02 10^9 cells/liter | Standard Deviation 0.182 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocyte; Week 52; n= 265, 229 | 0.01 10^9 cells/liter | Standard Deviation 0.173 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocyte; Week 4; n= 289, 291 | 0.13 10^9 cells/liter | Standard Deviation 0.519 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophil; Week 4; n= 289, 291 | 0.35 10^9 cells/liter | Standard Deviation 1.914 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophil; Week 36; n= 283, 275 | 0.01 10^9 cells/liter | Standard Deviation 0.021 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophil; Week 8; n= 296, 289 | 0.27 10^9 cells/liter | Standard Deviation 1.491 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocyte; Week 8; n= 296, 289 | 0.23 10^9 cells/liter | Standard Deviation 0.592 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophil; Week 16; n= 286, 286 | 0.31 10^9 cells/liter | Standard Deviation 1.462 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophil; Week 8; n= 296, 289 | 0.03 10^9 cells/liter | Standard Deviation 0.281 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophil; Week 24; n= 290, 281 | 0.42 10^9 cells/liter | Standard Deviation 1.694 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocyte; Week 16; n= 286, 286 | 0.28 10^9 cells/liter | Standard Deviation 0.611 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophil; Week 36; n= 283, 275 | 0.50 10^9 cells/liter | Standard Deviation 1.605 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophil; Week 8; n= 296, 289 | 0.00 10^9 cells/liter | Standard Deviation 0.017 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophil; Week 48; n= 266, 242 | 0.46 10^9 cells/liter | Standard Deviation 1.491 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocyte; Week 24; n= 290, 281 | 0.31 10^9 cells/liter | Standard Deviation 0.589 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophil; Week 52; n= 265, 229 | 0.63 10^9 cells/liter | Standard Deviation 1.691 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophil; Week 16; n= 286, 286 | 0.01 10^9 cells/liter | Standard Deviation 0.24 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelet; Week 4; n= 291, 293 | 22.81 10^9 cells/liter | Standard Deviation 63.368 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocyte; Week 36; n= 283, 275 | 0.38 10^9 cells/liter | Standard Deviation 0.595 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelet; Week 8; n= 293, 293 | 22.95 10^9 cells/liter | Standard Deviation 62.969 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophil; Week 48; n= 266, 242 | 0.01 10^9 cells/liter | Standard Deviation 0.021 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelet; Week 16; n= 287, 286 | 21.77 10^9 cells/liter | Standard Deviation 66.974 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocyte; Week 48; n= 266, 242 | 0.38 10^9 cells/liter | Standard Deviation 0.648 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelet; Week 24; n= 290, 282 | 19.79 10^9 cells/liter | Standard Deviation 63.702 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophil; Week 24; n= 290, 281 | 0.02 10^9 cells/liter | Standard Deviation 0.188 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelet; Week 36; n= 283, 274 | 20.02 10^9 cells/liter | Standard Deviation 69.57 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocyte; Week 52; n= 265, 229 | 0.34 10^9 cells/liter | Standard Deviation 0.716 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelet; Week 48; n= 265, 246 | 16.72 10^9 cells/liter | Standard Deviation 66.983 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophil; Week 24; n= 290, 281 | 0.01 10^9 cells/liter | Standard Deviation 0.017 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelet; Week 52; n= 267, 232 | 20.98 10^9 cells/liter | Standard Deviation 66.402 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocyte; Week 4; n= 289, 291 | 0.02 10^9 cells/liter | Standard Deviation 0.201 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocyte; Week 4; n= 289, 292 | 0.51 10^9 cells/liter | Standard Deviation 2.105 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophil; Week 36; n= 283, 275 | 0.04 10^9 cells/liter | Standard Deviation 0.214 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocyte; Week 8; n= 296, 292 | 0.54 10^9 cells/liter | Standard Deviation 1.676 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocyte; Week 8; n= 296, 289 | 0.01 10^9 cells/liter | Standard Deviation 0.159 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocyte; Week 16; n= 290, 288 | 0.61 10^9 cells/liter | Standard Deviation 1.622 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophil; Week 52; n= 265, 229 | 0.01 10^9 cells/liter | Standard Deviation 0.018 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocyte; Week 24; n= 291, 284 | 0.75 10^9 cells/liter | Standard Deviation 1.826 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocyte; Week 16; n= 286, 286 | -0.00 10^9 cells/liter | Standard Deviation 0.14 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocyte; Week 36; n= 285, 276 | 0.91 10^9 cells/liter | Standard Deviation 1.777 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophil; Week 48; n= 266, 242 | 0.04 10^9 cells/liter | Standard Deviation 0.267 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocyte; Week 48; n= 267, 245 | 0.91 10^9 cells/liter | Standard Deviation 1.777 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocyte; Week 24; n= 290, 281 | -0.01 10^9 cells/liter | Standard Deviation 0.139 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocyte; Week 52; 268, 231 | 0.99 10^9 cells/liter | Standard Deviation 1.908 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophil; Week 4; n= 289, 291 | 0.00 10^9 cells/liter | Standard Deviation 0.029 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocyte; Week 52; 268, 231 | 0.86 10^9 cells/liter | Standard Deviation 1.819 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophil; Week 4; n= 289, 291 | 0.00 10^9 cells/liter | Standard Deviation 0.016 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophil; Week 8; n= 296, 289 | 0.00 10^9 cells/liter | Standard Deviation 0.017 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophil; Week 16; n= 286, 286 | 0.00 10^9 cells/liter | Standard Deviation 0.017 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophil; Week 24; n= 290, 281 | 0.00 10^9 cells/liter | Standard Deviation 0.017 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophil; Week 36; n= 283, 275 | 0.00 10^9 cells/liter | Standard Deviation 0.018 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophil; Week 48; n= 266, 242 | 0.01 10^9 cells/liter | Standard Deviation 0.019 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Basophil; Week 52; n= 265, 229 | 0.01 10^9 cells/liter | Standard Deviation 0.022 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophil; Week 4; n= 290, 291 | 0.02 10^9 cells/liter | Standard Deviation 0.287 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophil; Week 8; n= 296, 289 | 0.01 10^9 cells/liter | Standard Deviation 0.175 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophil; Week 16; n= 286, 286 | 0.01 10^9 cells/liter | Standard Deviation 0.201 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophil; Week 24; n= 290, 281 | 0.01 10^9 cells/liter | Standard Deviation 0.173 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophil; Week 36; n= 283, 275 | 0.02 10^9 cells/liter | Standard Deviation 0.192 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophil; Week 48; n= 266, 242 | 0.01 10^9 cells/liter | Standard Deviation 0.21 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Eosinophil; Week 52; n= 265, 229 | 0.01 10^9 cells/liter | Standard Deviation 0.217 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocyte; Week 4; n= 289, 291 | 0.10 10^9 cells/liter | Standard Deviation 0.549 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocyte; Week 8; n= 296, 289 | 0.29 10^9 cells/liter | Standard Deviation 0.651 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocyte; Week 16; n= 286, 286 | 0.29 10^9 cells/liter | Standard Deviation 0.668 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocyte; Week 24; n= 290, 281 | 0.34 10^9 cells/liter | Standard Deviation 0.625 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocyte; Week 36; n= 283, 275 | 0.35 10^9 cells/liter | Standard Deviation 0.646 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocyte; Week 48; n= 266, 242 | 0.37 10^9 cells/liter | Standard Deviation 0.697 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Lymphocyte; Week 52; n= 265, 229 | 0.39 10^9 cells/liter | Standard Deviation 0.72 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocyte; Week 4; n= 289, 291 | 0.00 10^9 cells/liter | Standard Deviation 0.167 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocyte; Week 8; n= 296, 289 | 0.02 10^9 cells/liter | Standard Deviation 0.174 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocyte; Week 16; n= 286, 286 | 0.01 10^9 cells/liter | Standard Deviation 0.154 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocyte; Week 24; n= 290, 281 | 0.01 10^9 cells/liter | Standard Deviation 0.173 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocyte; Week 36; n= 283, 275 | 0.02 10^9 cells/liter | Standard Deviation 0.175 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocyte; Week 48; n= 266, 242 | 0.03 10^9 cells/liter | Standard Deviation 0.19 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Monocyte; Week 52; n= 265, 229 | 0.02 10^9 cells/liter | Standard Deviation 0.205 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophil; Week 4; n= 289, 291 | 0.23 10^9 cells/liter | Standard Deviation 1.407 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophil; Week 8; n= 296, 289 | 0.23 10^9 cells/liter | Standard Deviation 1.678 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophil; Week 16; n= 286, 286 | 0.29 10^9 cells/liter | Standard Deviation 1.481 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophil; Week 24; n= 290, 281 | 0.34 10^9 cells/liter | Standard Deviation 1.315 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophil; Week 36; n= 283, 275 | 0.37 10^9 cells/liter | Standard Deviation 1.661 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophil; Week 48; n= 266, 242 | 0.50 10^9 cells/liter | Standard Deviation 1.449 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Neutrophil; Week 52; n= 265, 229 | 0.44 10^9 cells/liter | Standard Deviation 1.604 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelet; Week 4; n= 291, 293 | 23.64 10^9 cells/liter | Standard Deviation 53.514 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelet; Week 8; n= 293, 293 | 26.17 10^9 cells/liter | Standard Deviation 58.634 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelet; Week 16; n= 287, 286 | 28.03 10^9 cells/liter | Standard Deviation 61.78 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelet; Week 24; n= 290, 282 | 27.32 10^9 cells/liter | Standard Deviation 65.103 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelet; Week 36; n= 283, 274 | 21.41 10^9 cells/liter | Standard Deviation 64.787 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelet; Week 48; n= 265, 246 | 30.20 10^9 cells/liter | Standard Deviation 63.038 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Platelet; Week 52; n= 267, 232 | 32.60 10^9 cells/liter | Standard Deviation 71.882 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocyte; Week 4; n= 289, 292 | 0.37 10^9 cells/liter | Standard Deviation 1.607 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocyte; Week 8; n= 296, 292 | 0.54 10^9 cells/liter | Standard Deviation 1.879 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocyte; Week 16; n= 290, 288 | 0.60 10^9 cells/liter | Standard Deviation 1.746 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocyte; Week 24; n= 291, 284 | 0.70 10^9 cells/liter | Standard Deviation 1.545 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocyte; Week 36; n= 285, 276 | 0.76 10^9 cells/liter | Standard Deviation 1.913 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes | Leukocyte; Week 48; n= 267, 245 | 0.90 10^9 cells/liter | Standard Deviation 1.718 |
Secondary
Change From Baseline in Creatinine and Bilirubin Values
Blood samples were collected from participants to evaluate clinical chemistry parameters including creatinine and bilirubin. Change from Baseline in clinical chemistry parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52
Population: Safety Population. Two participants who were randomized to receive LPV/RTV, received DTG and were included in DTG group for Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Creatinine and Bilirubin Values | Creatinine; Week 36; n= 289, 276 | 12.08 Micromoles per liter | Standard Deviation 9.667 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Creatinine and Bilirubin Values | Creatinine; Week 4; n= 306, 302 | 9.68 Micromoles per liter | Standard Deviation 9.308 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Creatinine and Bilirubin Values | Creatinine; Week 8; n= 301, 298 | 10.81 Micromoles per liter | Standard Deviation 8.414 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Creatinine and Bilirubin Values | Creatinine; Week 16; n= 294, 292 | 12.46 Micromoles per liter | Standard Deviation 9.065 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Creatinine and Bilirubin Values | Creatinine; Week 24; n= 295, 286 | 12.96 Micromoles per liter | Standard Deviation 10.248 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Creatinine and Bilirubin Values | Creatinine; Week 48; n= 278, 247 | 12.92 Micromoles per liter | Standard Deviation 9.412 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Creatinine and Bilirubin Values | Creatinine; Week 52; n= 276, 238 | 13.22 Micromoles per liter | Standard Deviation 10.229 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Creatinine and Bilirubin Values | Bilirubin; Week 4; n= 305, 301 | 1.74 Micromoles per liter | Standard Deviation 4.982 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Creatinine and Bilirubin Values | Bilirubin; Week 8; n= 301, 297 | 2.25 Micromoles per liter | Standard Deviation 4.344 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Creatinine and Bilirubin Values | Bilirubin; Week 16; n= 294, 292 | 2.79 Micromoles per liter | Standard Deviation 4.547 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Creatinine and Bilirubin Values | Bilirubin; Week 24; n= 295, 285 | 3.28 Micromoles per liter | Standard Deviation 4.692 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Creatinine and Bilirubin Values | Bilirubin; Week 36; n= 289, 275 | 3.26 Micromoles per liter | Standard Deviation 4.925 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Creatinine and Bilirubin Values | Bilirubin; Week 48; n= 278, 246 | 3.19 Micromoles per liter | Standard Deviation 4.288 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Creatinine and Bilirubin Values | Bilirubin; Week 52; n= 276, 238 | 3.54 Micromoles per liter | Standard Deviation 5.231 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Creatinine and Bilirubin Values | Bilirubin; Week 24; n= 295, 285 | 4.15 Micromoles per liter | Standard Deviation 5.422 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Creatinine and Bilirubin Values | Bilirubin; Week 4; n= 305, 301 | 3.39 Micromoles per liter | Standard Deviation 3.997 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Creatinine and Bilirubin Values | Creatinine; Week 4; n= 306, 302 | 4.69 Micromoles per liter | Standard Deviation 8.575 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Creatinine and Bilirubin Values | Bilirubin; Week 48; n= 278, 246 | 4.82 Micromoles per liter | Standard Deviation 5.552 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Creatinine and Bilirubin Values | Creatinine; Week 8; n= 301, 298 | 5.57 Micromoles per liter | Standard Deviation 9.214 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Creatinine and Bilirubin Values | Bilirubin; Week 8; n= 301, 297 | 3.76 Micromoles per liter | Standard Deviation 5.291 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Creatinine and Bilirubin Values | Creatinine; Week 16; n= 294, 292 | 5.19 Micromoles per liter | Standard Deviation 9.648 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Creatinine and Bilirubin Values | Bilirubin; Week 36; n= 289, 275 | 4.43 Micromoles per liter | Standard Deviation 5.447 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Creatinine and Bilirubin Values | Creatinine; Week 24; n= 295, 286 | 5.75 Micromoles per liter | Standard Deviation 11.606 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Creatinine and Bilirubin Values | Creatinine; Week 36; n= 289, 276 | 5.98 Micromoles per liter | Standard Deviation 14.737 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Creatinine and Bilirubin Values | Bilirubin; Week 16; n= 294, 292 | 3.97 Micromoles per liter | Standard Deviation 4.957 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Creatinine and Bilirubin Values | Creatinine; Week 48; n= 278, 247 | 6.15 Micromoles per liter | Standard Deviation 13.373 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Creatinine and Bilirubin Values | Bilirubin; Week 52; n= 276, 238 | 4.26 Micromoles per liter | Standard Deviation 4.644 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Creatinine and Bilirubin Values | Creatinine; Week 52; n= 276, 238 | 6.15 Micromoles per liter | Standard Deviation 12.268 |
Secondary
Change From Baseline in Erythrocyte Values
Blood samples were collected from participants to evaluate clinical hematology parameter including erythrocyte. Change from Baseline in erythrocyte values at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and up to Week 52
Population: Safety Population. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Erythrocyte Values | Week 16; n= 290, 289 | -0.06 10^12 cells/liter | Standard Deviation 0.808 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Erythrocyte Values | Week 36; n= 286, 276 | -0.01 10^12 cells/liter | Standard Deviation 0.792 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Erythrocyte Values | Week 8; n= 297, 294 | -0.07 10^12 cells/liter | Standard Deviation 0.558 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Erythrocyte Values | Week 48; n= 268, 248 | 0.01 10^12 cells/liter | Standard Deviation 0.798 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Erythrocyte Values | Week 24; n= 291, 285 | -0.08 10^12 cells/liter | Standard Deviation 0.768 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Erythrocyte Values | Week 52; n= 269, 233 | -0.01 10^12 cells/liter | Standard Deviation 0.788 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Erythrocyte Values | Week 4; n= 296, 296 | -0.08 10^12 cells/liter | Standard Deviation 0.385 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Erythrocyte Values | Week 52; n= 269, 233 | -0.17 10^12 cells/liter | Standard Deviation 0.761 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Erythrocyte Values | Week 4; n= 296, 296 | -0.16 10^12 cells/liter | Standard Deviation 0.363 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Erythrocyte Values | Week 8; n= 297, 294 | -0.23 10^12 cells/liter | Standard Deviation 0.529 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Erythrocyte Values | Week 16; n= 290, 289 | -0.21 10^12 cells/liter | Standard Deviation 0.754 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Erythrocyte Values | Week 24; n= 291, 285 | -0.20 10^12 cells/liter | Standard Deviation 0.747 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Erythrocyte Values | Week 36; n= 286, 276 | -0.18 10^12 cells/liter | Standard Deviation 0.749 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Erythrocyte Values | Week 48; n= 268, 248 | -0.18 10^12 cells/liter | Standard Deviation 0.75 |
Secondary
Change From Baseline in Fasting LDL Cholesterol at Week 24 and Week 48
Blood samples were collected from participants in fasting state to evaluate LDL cholesterol. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Analysis was performed using multiple imputation with missing at random assumption. Only participants available at the time of evaluation were analyzed.
Time frame: Baseline (Day 1, Pre-dose), Week 24 and Week 48
Population: Safety Population. Only those participants with data available at specified time points were analyzed. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Fasting LDL Cholesterol at Week 24 and Week 48 | Week 24 | -0.121 Millimoles per liter | Standard Error 0.0356 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Fasting LDL Cholesterol at Week 24 and Week 48 | Week 48 | -0.012 Millimoles per liter | Standard Error 0.0387 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Fasting LDL Cholesterol at Week 24 and Week 48 | Week 24 | 0.050 Millimoles per liter | Standard Error 0.0378 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Fasting LDL Cholesterol at Week 24 and Week 48 | Week 48 | 0.135 Millimoles per liter | Standard Error 0.0416 |
p-value: 0.00195% CI: [-0.272, -0.069]Multiple imputation
p-value: 0.0195% CI: [-0.259, -0.035]'Multiple imputation
Secondary
Change From Baseline in Fasting Total Cholesterol/HDL Cholesterol Ratio
Blood samples were collected from participants in fasting state to evaluate total cholesterol/HDL cholesterol ratio. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Only participants available at the time of evaluation were analyzed. Analysis was performed using multiple imputation with missing at random assumption.
Time frame: Baseline (Day 1, Pre-dose), Week 24 and Week 48
Population: Safety Population. Only those participants with data available at specified time point were analyzed. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Fasting Total Cholesterol/HDL Cholesterol Ratio | Week 24 | -0.237 Ratio | Standard Error 0.0662 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Fasting Total Cholesterol/HDL Cholesterol Ratio | Week 48 | -0.084 Ratio | Standard Error 0.0693 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Fasting Total Cholesterol/HDL Cholesterol Ratio | Week 24 | 0.305 Ratio | Standard Error 0.0683 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Fasting Total Cholesterol/HDL Cholesterol Ratio | Week 48 | 0.275 Ratio | Standard Error 0.0729 |
p-value: <0.000195% CI: [-0.729, -0.356]Multiple imputation
p-value: 0.000495% CI: [-0.555, -0.161]Multiple imputation
Secondary
Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score
The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea and Constipation. The scale ranges from 1= no discomfort to 7= very severe discomfort for each symptom cluster. Higher scores show greater severity of symptoms. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. The analysis was performed using Last Observation Carried Forward (LOCF) dataset. In the LOCF dataset, missing values were carried forward from the previous, non-missing available on-treatment assessment.
Time frame: Baseline (Day 1, Pre-dose), Week 4, Week 24, Week 48
Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score | Indigestion Syndrome Score; Week 24; n= 306, 307 | 0.00 Scores on a scale |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score | Constipation Score; Week 48; n= 306, 306 | 0.00 Scores on a scale |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score | Diarrhea Syndrome Score; Week 24; n= 305, 306 | 0.00 Scores on a scale |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score | Abdominal pain Score; Week 4; n= 305, 306 | 0.00 Scores on a scale |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score | Indigestion Syndrome Score; Week 48; n= 306, 307 | 0.00 Scores on a scale |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score | Abdominal pain Score; Week 24; n= 306, 307 | 0.00 Scores on a scale |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score | Indigestion Syndrome Score; Week 4; n=305, 306 | 0.00 Scores on a scale |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score | Abdominal pain Score; Week 48; n= 306, 307 | 0.00 Scores on a scale |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score | Constipation Score; Week 4; n= 305, 305 | 0.00 Scores on a scale |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score | Reflux Score; Week 4; n= 305, 306 | 0.00 Scores on a scale |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score | Diarrhea Syndrome Score; Week 48; n= 305, 306 | 0.00 Scores on a scale |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score | Reflux Score; Week 24; n= 306, 307 | 0.00 Scores on a scale |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score | Constipation Score; Week 24; n= 306, 306 | 0.00 Scores on a scale |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score | Reflux Score; Week 48; n= 306, 307 | 0.00 Scores on a scale |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score | Diarrhea Syndrome Score; Week 4; n= 303, 305 | 0.00 Scores on a scale |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score | Reflux Score; Week 48; n= 306, 307 | 0.00 Scores on a scale |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score | Diarrhea Syndrome Score; Week 4; n= 303, 305 | 0.00 Scores on a scale |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score | Diarrhea Syndrome Score; Week 24; n= 305, 306 | 0.00 Scores on a scale |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score | Diarrhea Syndrome Score; Week 48; n= 305, 306 | 0.00 Scores on a scale |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score | Indigestion Syndrome Score; Week 4; n=305, 306 | 0.00 Scores on a scale |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score | Indigestion Syndrome Score; Week 24; n= 306, 307 | 0.00 Scores on a scale |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score | Indigestion Syndrome Score; Week 48; n= 306, 307 | 0.00 Scores on a scale |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score | Constipation Score; Week 4; n= 305, 305 | 0.00 Scores on a scale |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score | Constipation Score; Week 24; n= 306, 306 | 0.00 Scores on a scale |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score | Constipation Score; Week 48; n= 306, 306 | 0.00 Scores on a scale |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score | Abdominal pain Score; Week 4; n= 305, 306 | 0.00 Scores on a scale |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score | Abdominal pain Score; Week 24; n= 306, 307 | 0.00 Scores on a scale |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score | Abdominal pain Score; Week 48; n= 306, 307 | 0.00 Scores on a scale |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score | Reflux Score; Week 4; n= 305, 306 | 0.00 Scores on a scale |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score | Reflux Score; Week 24; n= 306, 307 | 0.00 Scores on a scale |
Secondary
Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides
Blood samples were collected from participants to evaluate clinical chemistry parameters including glucose, chloride, carbon-di-oxide (CO2), potassium, phosphate, sodium, urea, cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides. Lipid parameters were evaluated in fasting condition. Change from Baseline in clinical chemistry parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52
Population: Safety Population. Two participants who were randomized to receive LPV/RTV, received DTG and were included in DTG group for Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Glucose; Week 4; n= 279, 277 | 0.07 Millimoles per liter | Standard Deviation 0.789 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Glucose; Week 8; n= 273, 271 | 0.08 Millimoles per liter | Standard Deviation 1.086 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Glucose; Week 16; n= 280, 275 | 0.07 Millimoles per liter | Standard Deviation 0.74 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Glucose; Week 24; n= 288, 276 | 0.22 Millimoles per liter | Standard Deviation 2.286 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Glucose; Week 36; n= 270, 257 | 0.18 Millimoles per liter | Standard Deviation 1.056 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Glucose; Week 48; n= 269, 237 | 0.12 Millimoles per liter | Standard Deviation 1.099 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Glucose; Week 52; n= 258, 221 | 0.16 Millimoles per liter | Standard Deviation 1.142 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Chloride; Week 4; n= 306, 302 | -0.20 Millimoles per liter | Standard Deviation 2.692 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Chloride; Week 8; n= 301, 298 | -0.15 Millimoles per liter | Standard Deviation 2.752 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Chloride; Week 16; n= 294, 292 | 0.04 Millimoles per liter | Standard Deviation 2.709 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Chloride; Week 24; n= 295, 286 | -0.17 Millimoles per liter | Standard Deviation 2.887 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Chloride; Week 36; n= 289, 276 | -0.18 Millimoles per liter | Standard Deviation 2.569 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Chloride; Week 48; n= 278, 247 | -0.03 Millimoles per liter | Standard Deviation 2.663 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Chloride; Week 52; n= 276, 238 | 0.06 Millimoles per liter | Standard Deviation 3.111 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | CO2; Week 4; n= 306, 302 | 0.12 Millimoles per liter | Standard Deviation 2.754 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | CO2; Week 8; n= 301, 297 | -0.01 Millimoles per liter | Standard Deviation 2.695 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | CO2; Week 16; n= 294, 292 | 0.21 Millimoles per liter | Standard Deviation 2.978 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | CO2; Week 24; n= 295, 286 | 0.13 Millimoles per liter | Standard Deviation 2.818 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | CO2; Week 36; n= 289, 276 | 0.16 Millimoles per liter | Standard Deviation 2.62 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | CO2; Week 48; n= 278, 247 | 0.06 Millimoles per liter | Standard Deviation 2.672 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | CO2; Week 52; n= 276, 238 | 0.04 Millimoles per liter | Standard Deviation 2.736 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Potassium; Week 4; n= 306, 302 | 0.07 Millimoles per liter | Standard Deviation 0.373 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Potassium; Week 8; n= 301, 297 | 0.09 Millimoles per liter | Standard Deviation 0.35 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Potassium; Week 16; n= 294, 292 | 0.10 Millimoles per liter | Standard Deviation 0.375 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Potassium; Week 24; n= 295, 286 | 0.11 Millimoles per liter | Standard Deviation 0.401 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Potassium; Week 36; n= 289, 276 | 0.08 Millimoles per liter | Standard Deviation 0.363 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Potassium; Week 48; n= 278, 247 | 0.07 Millimoles per liter | Standard Deviation 0.369 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Potassium; Week 52; n= 276, 238 | 0.11 Millimoles per liter | Standard Deviation 0.412 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Phosphate; Week 4; n= 306, 302 | 0.11 Millimoles per liter | Standard Deviation 0.188 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Phosphate; Week 8; n= 301, 298 | 0.11 Millimoles per liter | Standard Deviation 0.182 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Phosphate; Week 16; n= 294, 292 | 0.10 Millimoles per liter | Standard Deviation 0.18 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Phosphate; Week 24; n= 295, 286 | 0.11 Millimoles per liter | Standard Deviation 0.174 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Phosphate; Week 36; n= 289, 276 | 0.08 Millimoles per liter | Standard Deviation 0.196 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Phosphate; Week 48; n= 278, 247 | 0.06 Millimoles per liter | Standard Deviation 0.193 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Phosphate; Week 52; n= 276, 238 | 0.06 Millimoles per liter | Standard Deviation 0.203 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Sodium; Week 4; n= 306, 302 | -0.20 Millimoles per liter | Standard Deviation 2.393 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Sodium; Week 8; n= 301, 298 | -0.12 Millimoles per liter | Standard Deviation 2.42 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Sodium; Week 16; n= 294, 292 | 0.29 Millimoles per liter | Standard Deviation 2.364 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Sodium; Week 24; n= 295, 286 | -0.07 Millimoles per liter | Standard Deviation 2.472 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Sodium; Week 36; n= 289, 276 | 0.08 Millimoles per liter | Standard Deviation 2.375 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Sodium; Week 48; n= 278, 247 | 0.22 Millimoles per liter | Standard Deviation 2.277 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Sodium; Week 52; n= 276, 238 | 0.09 Millimoles per liter | Standard Deviation 2.886 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Urea; Week 4; n= 306, 302 | 0.21 Millimoles per liter | Standard Deviation 1.658 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Urea; Week 8; n= 301, 298 | 0.21 Millimoles per liter | Standard Deviation 1.214 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Urea; Week 16; n= 294, 292 | 0.25 Millimoles per liter | Standard Deviation 1.269 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Urea; Week 24; n= 295, 286 | 0.35 Millimoles per liter | Standard Deviation 1.236 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Urea; Week 36; n= 289, 276 | 0.11 Millimoles per liter | Standard Deviation 1.165 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Urea; Week 48; n= 278, 247 | 0.19 Millimoles per liter | Standard Deviation 1.26 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Urea; Week 52; n= 276, 238 | 0.30 Millimoles per liter | Standard Deviation 1.482 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Cholesterol; Week 4; n= 4, 6 | -0.88 Millimoles per liter | Standard Deviation 1.081 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Cholesterol; Week 8; n= 7, 10 | -0.37 Millimoles per liter | Standard Deviation 1.158 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Cholesterol; Week 16; n= 270, 261 | -0.22 Millimoles per liter | Standard Deviation 0.878 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Cholesterol; Week 24; n= 280, 271 | -0.23 Millimoles per liter | Standard Deviation 0.76 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Cholesterol; Week 36; n= 283, 272 | -0.24 Millimoles per liter | Standard Deviation 0.789 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Cholesterol; Week 48; n= 276, 272 | -0.10 Millimoles per liter | Standard Deviation 0.808 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Cholesterol; Week 52; n= 7, 6 | 0.35 Millimoles per liter | Standard Deviation 0.593 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | HDL cholesterol; Week 4; n= 4, 6 | -0.18 Millimoles per liter | Standard Deviation 0.197 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | HDL cholesterol; Week 8; n= 7,10 | -0.01 Millimoles per liter | Standard Deviation 0.262 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | HDL cholesterol; Week 16; n= 270, 261 | -0.02 Millimoles per liter | Standard Deviation 0.3 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | HDL cholesterol; Week 24; n= 280, 271 | -0.02 Millimoles per liter | Standard Deviation 0.319 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | HDL cholesterol; Week 36; n= 283, 272 | -0.02 Millimoles per liter | Standard Deviation 0.319 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | HDL cholesterol; Week 48; n= 276, 272 | -0.02 Millimoles per liter | Standard Deviation 0.298 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | HDL cholesterol; Week 52; n= 7,6 | 0.18 Millimoles per liter | Standard Deviation 0.327 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | LDL cholesterol; Week 4; n= 4, 3 | -0.29 Millimoles per liter | Standard Deviation 1.157 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | LDL cholesterol; Week 8; n= 7, 8 | -0.09 Millimoles per liter | Standard Deviation 0.911 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | LDL cholesterol; Week 16; n= 259, 246 | -0.10 Millimoles per liter | Standard Deviation 0.674 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | LDL cholesterol; Week 24; n= 272, 261 | -0.10 Millimoles per liter | Standard Deviation 0.601 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | LDL cholesterol; Week 36; n= 274, 261 | -0.11 Millimoles per liter | Standard Deviation 0.606 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | LDL cholesterol; Week 48; n= 269, 264 | -0.01 Millimoles per liter | Standard Deviation 0.633 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | LDL cholesterol; Week 52; n= 7, 6 | 0.06 Millimoles per liter | Standard Deviation 0.511 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Triglycerides; Week 4; n= 4, 6 | -0.89 Millimoles per liter | Standard Deviation 0.852 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Triglycerides; Week 8; n= 7, 10 | -0.57 Millimoles per liter | Standard Deviation 1.153 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Triglycerides; Week 16; n= 270, 261 | -0.32 Millimoles per liter | Standard Deviation 1.131 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Triglycerides; Week 24; n= 280, 271 | -0.32 Millimoles per liter | Standard Deviation 0.997 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Triglycerides; Week 36; n= 283, 272 | -0.31 Millimoles per liter | Standard Deviation 1.289 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Triglycerides; Week 48; n= 276, 272 | -0.24 Millimoles per liter | Standard Deviation 1.12 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Triglycerides; Week 52; n= 7, 6 | 0.22 Millimoles per liter | Standard Deviation 0.769 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Sodium; Week 24; n= 295, 286 | -0.53 Millimoles per liter | Standard Deviation 2.446 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Glucose; Week 4; n= 279, 277 | 0.01 Millimoles per liter | Standard Deviation 0.661 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | LDL cholesterol; Week 36; n= 274, 261 | 0.05 Millimoles per liter | Standard Deviation 0.659 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Glucose; Week 8; n= 273, 271 | -0.00 Millimoles per liter | Standard Deviation 0.914 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Sodium; Week 36; n= 289, 276 | -0.51 Millimoles per liter | Standard Deviation 2.41 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Glucose; Week 16; n= 280, 275 | -0.06 Millimoles per liter | Standard Deviation 1.06 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | HDL cholesterol; Week 16; n= 270, 261 | -0.00 Millimoles per liter | Standard Deviation 0.341 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Glucose; Week 24; n= 288, 276 | -0.04 Millimoles per liter | Standard Deviation 1.037 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Sodium; Week 48; n= 278, 247 | -0.62 Millimoles per liter | Standard Deviation 2.505 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Glucose; Week 36; n= 270, 257 | -0.01 Millimoles per liter | Standard Deviation 1.176 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Triglycerides; Week 16; n= 270, 261 | 0.63 Millimoles per liter | Standard Deviation 1.289 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Glucose; Week 48; n= 269, 237 | -0.01 Millimoles per liter | Standard Deviation 1.028 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Sodium; Week 52; n= 276, 238 | -0.37 Millimoles per liter | Standard Deviation 2.402 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Glucose; Week 52; n= 258, 221 | -0.01 Millimoles per liter | Standard Deviation 1.443 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | HDL cholesterol; Week 24; n= 280, 271 | 0.00 Millimoles per liter | Standard Deviation 0.339 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Chloride; Week 4; n= 306, 302 | -0.96 Millimoles per liter | Standard Deviation 2.751 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Urea; Week 4; n= 306, 302 | 0.18 Millimoles per liter | Standard Deviation 1.253 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Chloride; Week 8; n= 301, 298 | -1.00 Millimoles per liter | Standard Deviation 2.833 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | LDL cholesterol; Week 48; n= 269, 264 | 0.11 Millimoles per liter | Standard Deviation 0.682 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Chloride; Week 16; n= 294, 292 | -0.78 Millimoles per liter | Standard Deviation 2.773 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Urea; Week 8; n= 301, 298 | 0.23 Millimoles per liter | Standard Deviation 1.205 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Chloride; Week 24; n= 295, 286 | -0.67 Millimoles per liter | Standard Deviation 2.818 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | HDL cholesterol; Week 36; n= 283, 272 | 0.00 Millimoles per liter | Standard Deviation 0.34 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Chloride; Week 36; n= 289, 276 | -0.51 Millimoles per liter | Standard Deviation 2.88 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Urea; Week 16; n= 294, 292 | 0.29 Millimoles per liter | Standard Deviation 1.344 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Chloride; Week 48; n= 278, 247 | -0.81 Millimoles per liter | Standard Deviation 2.441 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Triglycerides; Week 52; n= 7, 6 | -0.15 Millimoles per liter | Standard Deviation 0.259 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Chloride; Week 52; n= 276, 238 | -0.38 Millimoles per liter | Standard Deviation 2.739 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Urea; Week 24; n= 295, 286 | 0.17 Millimoles per liter | Standard Deviation 1.308 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | CO2; Week 4; n= 306, 302 | -0.22 Millimoles per liter | Standard Deviation 2.65 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | HDL cholesterol; Week 48; n= 276, 272 | 0.03 Millimoles per liter | Standard Deviation 0.353 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | CO2; Week 8; n= 301, 297 | -0.09 Millimoles per liter | Standard Deviation 2.564 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Urea; Week 36; n= 289, 276 | 0.20 Millimoles per liter | Standard Deviation 1.284 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | CO2; Week 16; n= 294, 292 | 0.04 Millimoles per liter | Standard Deviation 2.638 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | LDL cholesterol; Week 52; n= 7, 6 | -0.25 Millimoles per liter | Standard Deviation 0.857 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | CO2; Week 24; n= 295, 286 | -0.08 Millimoles per liter | Standard Deviation 2.777 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Urea; Week 48; n= 278, 247 | 0.18 Millimoles per liter | Standard Deviation 1.241 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | CO2; Week 36; n= 289, 276 | -0.12 Millimoles per liter | Standard Deviation 2.861 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | HDL cholesterol; Week 52; n= 7,6 | 0.13 Millimoles per liter | Standard Deviation 0.327 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | CO2; Week 48; n= 278, 247 | 0.28 Millimoles per liter | Standard Deviation 2.867 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Urea; Week 52; n= 276, 238 | 0.32 Millimoles per liter | Standard Deviation 1.311 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | CO2; Week 52; n= 276, 238 | 0.12 Millimoles per liter | Standard Deviation 2.555 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Triglycerides; Week 24; n= 280, 271 | 0.67 Millimoles per liter | Standard Deviation 1.826 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Potassium; Week 4; n= 306, 302 | -0.02 Millimoles per liter | Standard Deviation 0.432 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Cholesterol; Week 4; n= 4, 6 | 1.22 Millimoles per liter | Standard Deviation 1.963 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Potassium; Week 8; n= 301, 297 | 0.00 Millimoles per liter | Standard Deviation 0.428 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | LDL cholesterol; Week 4; n= 4, 3 | -0.17 Millimoles per liter | Standard Deviation 0.398 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Potassium; Week 16; n= 294, 292 | 0.03 Millimoles per liter | Standard Deviation 0.443 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Cholesterol; Week 8; n= 7, 10 | 1.04 Millimoles per liter | Standard Deviation 1.577 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Potassium; Week 24; n= 295, 286 | 0.03 Millimoles per liter | Standard Deviation 0.433 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Triglycerides; Week 4; n= 4, 6 | 4.23 Millimoles per liter | Standard Deviation 5.773 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Potassium; Week 36; n= 289, 276 | -0.03 Millimoles per liter | Standard Deviation 0.417 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Cholesterol; Week 16; n= 270, 261 | 0.31 Millimoles per liter | Standard Deviation 0.872 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Potassium; Week 48; n= 278, 247 | 0.05 Millimoles per liter | Standard Deviation 0.423 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | LDL cholesterol; Week 8; n= 7, 8 | 0.50 Millimoles per liter | Standard Deviation 0.72 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Potassium; Week 52; n= 276, 238 | 0.04 Millimoles per liter | Standard Deviation 0.416 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Cholesterol; Week 24; n= 280, 271 | 0.29 Millimoles per liter | Standard Deviation 0.934 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Phosphate; Week 4; n= 306, 302 | 0.01 Millimoles per liter | Standard Deviation 0.206 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Triglycerides; Week 48; n= 276, 272 | 0.57 Millimoles per liter | Standard Deviation 1.488 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Phosphate; Week 8; n= 301, 298 | 0.03 Millimoles per liter | Standard Deviation 0.187 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Cholesterol; Week 36; n= 283, 272 | 0.28 Millimoles per liter | Standard Deviation 0.901 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Phosphate; Week 16; n= 294, 292 | 0.03 Millimoles per liter | Standard Deviation 0.193 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | LDL cholesterol; Week 16; n= 259, 246 | 0.06 Millimoles per liter | Standard Deviation 0.644 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Phosphate; Week 24; n= 295, 286 | 0.03 Millimoles per liter | Standard Deviation 0.2 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Cholesterol; Week 48; n= 276, 272 | 0.38 Millimoles per liter | Standard Deviation 0.946 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Phosphate; Week 36; n= 289, 276 | 0.01 Millimoles per liter | Standard Deviation 0.217 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Triglycerides; Week 8; n= 7, 10 | 1.95 Millimoles per liter | Standard Deviation 5.131 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Phosphate; Week 48; n= 278, 247 | 0.03 Millimoles per liter | Standard Deviation 0.209 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Cholesterol; Week 52; n= 7, 6 | -0.18 Millimoles per liter | Standard Deviation 0.85 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Phosphate; Week 52; n= 276, 238 | 0.01 Millimoles per liter | Standard Deviation 0.197 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | LDL cholesterol; Week 24; n= 272, 261 | 0.05 Millimoles per liter | Standard Deviation 0.652 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Sodium; Week 4; n= 306, 302 | -0.80 Millimoles per liter | Standard Deviation 2.284 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | HDL cholesterol; Week 4; n= 4, 6 | 0.10 Millimoles per liter | Standard Deviation 0.191 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Sodium; Week 8; n= 301, 298 | -0.87 Millimoles per liter | Standard Deviation 2.569 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Triglycerides; Week 36; n= 283, 272 | 0.61 Millimoles per liter | Standard Deviation 1.497 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | Sodium; Week 16; n= 294, 292 | -0.58 Millimoles per liter | Standard Deviation 2.449 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides | HDL cholesterol; Week 8; n= 7,10 | 0.08 Millimoles per liter | Standard Deviation 0.363 |
Secondary
Change From Baseline in Helper-inducer T-lymphocyte Having Surface Antigen Cluster of Differentiation (CD4+) Cell Count at Weeks 24 and 48
Blood was collected and CD4+ cell count assessment was carried out at indicated time points to evaluate the immunological activity of DTG compared to LPV/RTV. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Week 24 and Week 48
Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Helper-inducer T-lymphocyte Having Surface Antigen Cluster of Differentiation (CD4+) Cell Count at Weeks 24 and 48 | Week 24; n= 291, 285 | 84.0 Cells per cubic millimeter (Cells/mm^3) |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Helper-inducer T-lymphocyte Having Surface Antigen Cluster of Differentiation (CD4+) Cell Count at Weeks 24 and 48 | Week 48; n= 275, 251 | 120.0 Cells per cubic millimeter (Cells/mm^3) |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Helper-inducer T-lymphocyte Having Surface Antigen Cluster of Differentiation (CD4+) Cell Count at Weeks 24 and 48 | Week 24; n= 291, 285 | 82.0 Cells per cubic millimeter (Cells/mm^3) |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Helper-inducer T-lymphocyte Having Surface Antigen Cluster of Differentiation (CD4+) Cell Count at Weeks 24 and 48 | Week 48; n= 275, 251 | 118.0 Cells per cubic millimeter (Cells/mm^3) |
Secondary
Change From Baseline in Hematocrit Values
Blood samples were collected from participants to evaluate clinical hematology parameter including hematocrit. Change from Baseline in hematocrit values at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and and Week 52
Population: Safety Population. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Hematocrit Values | Week 16; n= 290, 289 | 0.01 Proportion of red blood cells in blood | Standard Deviation 0.044 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Hematocrit Values | Week 36; n= 286, 276 | 0.01 Proportion of red blood cells in blood | Standard Deviation 0.038 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Hematocrit Values | Week 8; n= 297, 294 | 0.00 Proportion of red blood cells in blood | Standard Deviation 0.039 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Hematocrit Values | Week 48; n= 268, 248 | 0.02 Proportion of red blood cells in blood | Standard Deviation 0.038 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Hematocrit Values | Week 24; n= 291, 285 | 0.01 Proportion of red blood cells in blood | Standard Deviation 0.037 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Hematocrit Values | Week 52; n= 269, 233 | 0.02 Proportion of red blood cells in blood | Standard Deviation 0.04 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Hematocrit Values | Week 4; n= 296, 296 | -0.00 Proportion of red blood cells in blood | Standard Deviation 0.032 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Hematocrit Values | Week 52; n= 269, 233 | -0.00 Proportion of red blood cells in blood | Standard Deviation 0.041 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Hematocrit Values | Week 4; n= 296, 296 | -0.01 Proportion of red blood cells in blood | Standard Deviation 0.029 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Hematocrit Values | Week 8; n= 297, 294 | -0.01 Proportion of red blood cells in blood | Standard Deviation 0.037 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Hematocrit Values | Week 16; n= 290, 289 | -0.01 Proportion of red blood cells in blood | Standard Deviation 0.042 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Hematocrit Values | Week 24; n= 291, 285 | -0.00 Proportion of red blood cells in blood | Standard Deviation 0.039 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Hematocrit Values | Week 36; n= 286, 276 | -0.00 Proportion of red blood cells in blood | Standard Deviation 0.039 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Hematocrit Values | Week 48; n= 268, 248 | -0.00 Proportion of red blood cells in blood | Standard Deviation 0.041 |
Secondary
Change From Baseline in Hemoglobin Values
Blood samples were collected from participants to evaluate clinical hematology parameter including hemoglobin. Change from Baseline in hemoglobin values at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52
Population: Safety Population. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Hemoglobin Values | Week 16; n= 290, 289 | 2.39 Gram per liter | Standard Deviation 12.905 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Hemoglobin Values | Week 36; n= 286, 276 | 5.18 Gram per liter | Standard Deviation 11.968 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Hemoglobin Values | Week 8; n= 297, 294 | -0.12 Gram per liter | Standard Deviation 11.725 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Hemoglobin Values | Week 48; n= 268, 248 | 6.05 Gram per liter | Standard Deviation 12.138 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Hemoglobin Values | Week 24; n= 291, 285 | 3.05 Gram per liter | Standard Deviation 10.881 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Hemoglobin Values | Week 52; n= 269, 233 | 5.68 Gram per liter | Standard Deviation 12.457 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Hemoglobin Values | Week 4; n= 296, 296 | -1.33 Gram per liter | Standard Deviation 9.858 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Hemoglobin Values | Week 52; n= 269, 233 | 1.07 Gram per liter | Standard Deviation 13.361 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Hemoglobin Values | Week 4; n= 296, 296 | -4.23 Gram per liter | Standard Deviation 8.994 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Hemoglobin Values | Week 8; n= 297, 294 | -4.41 Gram per liter | Standard Deviation 11.34 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Hemoglobin Values | Week 16; n= 290, 289 | -2.10 Gram per liter | Standard Deviation 12.904 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Hemoglobin Values | Week 24; n= 291, 285 | -0.46 Gram per liter | Standard Deviation 12.363 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Hemoglobin Values | Week 36; n= 286, 276 | 0.34 Gram per liter | Standard Deviation 12.628 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Hemoglobin Values | Week 48; n= 268, 248 | 0.90 Gram per liter | Standard Deviation 13.486 |
Secondary
Change From Baseline in Lipase Values
Blood samples were collected from participants to evaluate clinical chemistry parameter including lipase. Change from Baseline in lipase at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52
Population: Safety Population. Two participants who were randomized to receive LPV/RTV, received DTG and were included in DTG group for Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Lipase Values | Week 16; n= 292, 293 | 2.01 Unit per liter | Standard Deviation 17.174 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Lipase Values | Week 36; n= 287, 275 | 0.49 Unit per liter | Standard Deviation 15.089 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Lipase Values | Week 8; n= 299, 298 | 0.79 Unit per liter | Standard Deviation 13.422 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Lipase Values | Week 48; n= 278, 247 | 1.13 Unit per liter | Standard Deviation 14.673 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Lipase Values | Week 24; n= 295, 284 | 1.19 Unit per liter | Standard Deviation 15.984 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Lipase Values | Week 52; n= 275, 237 | 3.18 Unit per liter | Standard Deviation 22.215 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Lipase Values | Week 4; n= 303, 301 | 0.17 Unit per liter | Standard Deviation 11.082 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Lipase Values | Week 52; n= 275, 237 | 1.59 Unit per liter | Standard Deviation 11.117 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Lipase Values | Week 4; n= 303, 301 | 1.52 Unit per liter | Standard Deviation 15.067 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Lipase Values | Week 8; n= 299, 298 | 0.58 Unit per liter | Standard Deviation 10.558 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Lipase Values | Week 16; n= 292, 293 | 0.94 Unit per liter | Standard Deviation 11.197 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Lipase Values | Week 24; n= 295, 284 | 1.14 Unit per liter | Standard Deviation 13.77 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Lipase Values | Week 36; n= 287, 275 | 0.11 Unit per liter | Standard Deviation 11.57 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Lipase Values | Week 48; n= 278, 247 | 1.68 Unit per liter | Standard Deviation 12.783 |
Secondary
Change From Baseline in Mean Corpuscular Volume (MCV)
Blood samples were collected from participants to evaluate clinical hematology parameter including MCV. Change from Baseline in MCV values at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.
Time frame: Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and and Week 52
Population: Safety Population. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Mean Corpuscular Volume (MCV) | Week 16; n= 290, 289 | 3.91 Femtoliter | Standard Deviation 13.827 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Mean Corpuscular Volume (MCV) | Week 36; n= 286, 276 | 4.33 Femtoliter | Standard Deviation 15.45 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Mean Corpuscular Volume (MCV) | Week 8; n= 297, 294 | 1.72 Femtoliter | Standard Deviation 7.659 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Mean Corpuscular Volume (MCV) | Week 48; n= 268, 248 | 4.14 Femtoliter | Standard Deviation 15.637 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Mean Corpuscular Volume (MCV) | Week 24; n= 291, 285 | 4.86 Femtoliter | Standard Deviation 15.279 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Mean Corpuscular Volume (MCV) | Week 52; n= 269, 233 | 4.36 Femtoliter | Standard Deviation 15.496 |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Mean Corpuscular Volume (MCV) | Week 4; n= 296, 296 | 0.68 Femtoliter | Standard Deviation 3.82 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Mean Corpuscular Volume (MCV) | Week 52; n= 269, 233 | 4.72 Femtoliter | Standard Deviation 15.697 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Mean Corpuscular Volume (MCV) | Week 4; n= 296, 296 | 0.46 Femtoliter | Standard Deviation 3.799 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Mean Corpuscular Volume (MCV) | Week 8; n= 297, 294 | 1.78 Femtoliter | Standard Deviation 7.266 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Mean Corpuscular Volume (MCV) | Week 16; n= 290, 289 | 3.83 Femtoliter | Standard Deviation 13.6 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Mean Corpuscular Volume (MCV) | Week 24; n= 291, 285 | 4.39 Femtoliter | Standard Deviation 15.099 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Mean Corpuscular Volume (MCV) | Week 36; n= 286, 276 | 4.62 Femtoliter | Standard Deviation 15.413 |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Mean Corpuscular Volume (MCV) | Week 48; n= 268, 248 | 4.79 Femtoliter | Standard Deviation 15.463 |
Secondary
Change From Baseline in Treatment Satisfaction, Using the HIV-Treatment Satisfaction Questionnaire (HIVTSQ) Score
The HIVTSQ is a self-reported scales that measure overall satisfaction with treatment. The score ranges from 0-10. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. The analysis was performed using LOCF dataset. In the LOCF dataset, missing values were carried forward from the previous, non-missing available on-treatment assessment.
Time frame: Baseline (Day 1, Pre-dose), Week 4, Week 24, Week 48
Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Treatment Satisfaction, Using the HIV-Treatment Satisfaction Questionnaire (HIVTSQ) Score | Week 4; n= 304, 306 | 3.4 Scores on a scale |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Treatment Satisfaction, Using the HIV-Treatment Satisfaction Questionnaire (HIVTSQ) Score | Week 24; n= 305, 307 | 5.0 Scores on a scale |
| Participants Receiving DTG-Randomized Phase | Change From Baseline in Treatment Satisfaction, Using the HIV-Treatment Satisfaction Questionnaire (HIVTSQ) Score | Week 48; n= 305, 307 | 5.0 Scores on a scale |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Treatment Satisfaction, Using the HIV-Treatment Satisfaction Questionnaire (HIVTSQ) Score | Week 4; n= 304, 306 | 2.0 Scores on a scale |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Treatment Satisfaction, Using the HIV-Treatment Satisfaction Questionnaire (HIVTSQ) Score | Week 24; n= 305, 307 | 3.0 Scores on a scale |
| Participants Receiving LPV/RTV-Randomized Phase | Change From Baseline in Treatment Satisfaction, Using the HIV-Treatment Satisfaction Questionnaire (HIVTSQ) Score | Week 48; n= 305, 307 | 3.0 Scores on a scale |
Secondary
Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8)
Treatment compliance was evaluated through MMAS-8. It is an eight-item self-reported measure of medication-taking behavior. The score ranges from 0-8 where scores of 8 indicate high or near perfect adherence, and scores of less than 6 indicate poor or inadequate adherence on the MMAS-8 scale. Number of participants showing low, medium and high adherence to treatment are presented. Low adherence is a score 0-5.75, medium adherence is a score of 6-7.75 and high adherence is a score of 8. The analysis was performed using LOCF dataset. In the LOCF dataset, missing values were carried forward from the previous, non-missing available on-treatment assessment.
Time frame: Baseline (Day 1, Pre-dose), Week 4, Week 24 and Week 48
Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Receiving DTG-Randomized Phase | Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) | Baseline (Day 1, Pre-dose); low; n= 309, 312 | 70 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) | Baseline (Day 1, Pre-dose); medium; n= 309, 312 | 102 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) | Baseline (Day 1, Pre-dose); high; n= 309, 312 | 137 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) | Week 4; low; n= 306, 306 | 17 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) | Week 4; medium; n= 306, 306 | 81 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) | Week 4; high n= 306, 306 | 208 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) | Week 24; low; n= 307, 307 | 25 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) | Week 24; medium; n= 307, 307 | 83 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) | Week 24; high; n= 307,307 | 199 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) | Week 48; low; n= 307, 307 | 28 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) | Week 48; medium; n= 307, 307 | 74 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) | Week 48; high; n= 307, 307 | 205 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) | Week 48; medium; n= 307, 307 | 82 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) | Baseline (Day 1, Pre-dose); low; n= 309, 312 | 75 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) | Week 24; low; n= 307, 307 | 39 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) | Baseline (Day 1, Pre-dose); medium; n= 309, 312 | 100 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) | Week 48; low; n= 307, 307 | 52 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) | Baseline (Day 1, Pre-dose); high; n= 309, 312 | 137 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) | Week 24; medium; n= 307, 307 | 76 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) | Week 4; low; n= 306, 306 | 37 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) | Week 48; high; n= 307, 307 | 173 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) | Week 4; medium; n= 306, 306 | 80 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) | Week 24; high; n= 307,307 | 192 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8) | Week 4; high n= 306, 306 | 189 Participants |
Secondary
Number of Participants Who Discontinued Treatment Due to AEs-Continuation Phase
Number of participants who discontinued study treatment due to AEs were summarized.
Time frame: Up to Week 295
Population: Safety-Continuation Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Receiving DTG-Randomized Phase | Number of Participants Who Discontinued Treatment Due to AEs-Continuation Phase | 9 Participants |
Secondary
Number of Participants Who Discontinued Treatment Due to AEs-Randomized Phase
Number of participants who discontinued study treatment due to AEs or SAEs were summarized.
Time frame: Up to Week 52
Population: Safety Population. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Receiving DTG-Randomized Phase | Number of Participants Who Discontinued Treatment Due to AEs-Randomized Phase | 8 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants Who Discontinued Treatment Due to AEs-Randomized Phase | 18 Participants |
Secondary
Number of Participants With Clinical Chemistry Toxicities-Continuation Phase
Number of participants with clinical chemistry toxicities has been presented. Toxicities were based on the Division of AIDS (DAIDS) grading system. Grade 1=Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Potentially life-threatening. Higher the grade, more severe the symptoms. Lipids and glucose parameters were summarized on fasting data. Data has been reported for clinical chemistry parameters including serum glucose, ALT, Albumin, ALP, AST, Bilirubin, CO2, Creatine kinase, LDL cholesterol calculation, LDL cholesterol direct, Lipase, Phosphate, Potassium, Sodium, Cholesterol, Creatinine and Serum Triglycerides.
Time frame: Up to Week 295
Population: Safety Continuation Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Serum glucose; Grade 1 | 43 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Serum glucose; Grade 2 | 33 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Serum glucose; Grade 3 | 9 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Serum glucose; Grade 4 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | ALT; Grade 1 | 46 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | ALT; Grade 2 | 16 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | ALT; Grade 3 | 2 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | ALT; Grade 4 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Albumin; Grade 1 | 1 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Albumin; Grade 2 | 4 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Albumin; Grade 3 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Albumin; Grade 4 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | ALP; Grade 1 | 13 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | ALP; Grade 2 | 2 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | ALP; Grade 3 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | ALP; Grade 4 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | AST; Grade 1 | 37 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | AST; Grade 2 | 11 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | AST; Grade 3 | 5 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | AST; Grade 4 | 1 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Bilirubin; Grade 1 | 14 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Bilirubin; Grade 2 | 9 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Bilirubin; Grade 3 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Bilirubin; Grade 4 | 2 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | CO2; Grade 1 | 83 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | CO2; Grade 2 | 20 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | CO2; Grade 3 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | CO2; Grade 4 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Creatine kinase; Grade 1 | 24 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Creatine kinase; Grade 2 | 6 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Creatine kinase; Grade 3 | 5 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Creatine kinase; Grade 4 | 5 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | LDL cholesterol calculation; Grade 1 | 1 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | LDL cholesterol calculation; Grade 2 | 1 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | LDL cholesterol calculation; Grade 3 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | LDL cholesterol calculation; Grade 4 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | LDL cholesterol direct; Grade 1 | 1 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | LDL cholesterol direct; Grade 2 | 1 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | LDL cholesterol direct; Grade 3 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | LDL cholesterol direct; Grade 4 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Lipase; Grade 1 | 19 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Lipase; Grade 2 | 9 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Lipase; Grade 3 | 2 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Lipase; Grade 4 | 4 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Phosphate; Grade 1 | 16 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Phosphate; Grade 2 | 38 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Phosphate; Grade 3 | 6 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Phosphate; Grade 4 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Potassium; Grade 1 | 24 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Potassium; Grade 2 | 5 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Potassium; Grade 3 | 1 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Potassium; Grade 4 | 1 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Sodium; Grade 1 | 69 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Sodium; Grade 2 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Sodium; Grade 3 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Sodium; Grade 4 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Cholesterol; Grade 1 | 1 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Cholesterol; Grade 2 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Cholesterol; Grade 3 | 1 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Cholesterol; Grade 4 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Creatinine; Grade 1 | 7 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Creatinine; Grade 2 | 4 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Creatinine; Grade 3 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Creatinine; Grade 4 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Serum Triglycerides; Grade 1 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Serum Triglycerides; Grade 2 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Serum Triglycerides; Grade 3 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities-Continuation Phase | Serum Triglycerides; Grade 4 | 1 Participants |
Secondary
Number of Participants With Clinical Chemistry Toxicities -Randomized Phase
Number of participants with clinical chemistry toxicities has been presented. Toxicities were based on the Division of AIDS (DAIDS) grading system. Grade 1=Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Potentially life-threatening. Higher the grade, more severe the symptoms. Lipids and glucose parameters were summarized on fasting data. Data has been reported for clinical chemistry parameters including serum glucose, ALT, Albumin, ALP, AST, Bilirubin, CO2, Creatine kinase, LDL cholesterol calculation, LDL cholesterol direct, Lipase, Phosphate, Potassium, Sodium, Cholesterol, Creatinine and Serum Triglycerides.
Time frame: Up to Week 52
Population: Safety Population. Two participants who were randomized to receive LPV/RTV, received DTG and were included in DTG group for Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Lipase; Grade 3 | 1 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Creatinine; Grade 1 | 1 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Creatinine; Grade 2 | 2 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Creatinine; Grade 3 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Creatinine; Grade 4 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Serum glucose; Grade 1 | 32 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Serum glucose; Grade 2 | 10 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Serum glucose; Grade 3 | 4 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Serum Triglycerides; Grade 1 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Serum glucose; Grade 4 | 1 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | ALT; Grade 1 | 27 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | ALT; Grade 2 | 9 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | ALT; Grade 3 | 3 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | ALT; Grade 4 | 1 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Albumin; Grade 1 | 7 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Albumin; Grade 2 | 4 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Albumin; Grade 3 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Albumin; Grade 4 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | ALP; Grade 1 | 9 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | ALP; Grade 2 | 4 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | ALP; Grade 3 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | ALP; Grade 4 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | AST; Grade 1 | 29 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | AST; Grade 2 | 10 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | AST; Grade 3 | 2 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | AST; Grade 4 | 1 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Bilirubin; Grade 1 | 14 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Bilirubin; Grade 2 | 3 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Bilirubin; Grade 3 | 2 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Bilirubin; Grade 4 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | CO2; Grade 1 | 99 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Serum Triglycerides; Grade 2 | 1 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | CO2; Grade 2 | 24 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | CO2; Grade 3 | 1 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | CO2; Grade 4 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Creatine kinase; Grade 1 | 13 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Creatine kinase; Grade 2 | 2 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Creatine kinase; Grade 3 | 5 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Creatine kinase; Grade 4 | 3 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Serum Triglycerides; Grade 3 | 1 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | LDL cholesterol calculation; Grade 1 | 17 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | LDL cholesterol calculation; Grade 2 | 4 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | LDL cholesterol calculation; Grade 3 | 1 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | LDL cholesterol calculation; Grade 4 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | LDL cholesterol direct; Grade 1 | 3 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | LDL cholesterol direct; Grade 2 | 2 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | LDL cholesterol direct; Grade 3 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | LDL cholesterol direct; Grade 4 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Serum Triglycerides; Grade 4 | 1 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Lipase; Grade 1 | 16 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Lipase; Grade 2 | 6 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Lipase; Grade 4 | 2 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Phosphate; Grade 1 | 7 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Phosphate; Grade 2 | 15 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Phosphate; Grade 3 | 5 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Phosphate; Grade 4 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Potassium; Grade 1 | 16 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Potassium; Grade 2 | 1 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Potassium; Grade 3 | 2 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Potassium; Grade 4 | 1 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Sodium; Grade 1 | 76 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Sodium; Grade 2 | 5 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Sodium; Grade 3 | 1 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Sodium; Grade 4 | 1 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Cholesterol; Grade 1 | 14 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Cholesterol; Grade 2 | 5 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Cholesterol; Grade 3 | 3 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Cholesterol; Grade 4 | 0 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Cholesterol; Grade 3 | 4 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Creatine kinase; Grade 1 | 6 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Creatinine; Grade 1 | 4 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Lipase; Grade 4 | 0 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Creatinine; Grade 2 | 5 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Creatine kinase; Grade 2 | 3 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Creatinine; Grade 3 | 0 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Potassium; Grade 4 | 1 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Creatinine; Grade 4 | 0 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Creatine kinase; Grade 3 | 3 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Serum glucose; Grade 1 | 27 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Phosphate; Grade 1 | 6 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Serum glucose; Grade 2 | 15 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Serum Triglycerides; Grade 2 | 11 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Sodium; Grade 4 | 0 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Serum glucose; Grade 3 | 1 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Creatine kinase; Grade 4 | 1 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Serum glucose; Grade 4 | 0 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Phosphate; Grade 2 | 42 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | ALT; Grade 1 | 13 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | LDL cholesterol calculation; Grade 1 | 20 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | ALT; Grade 2 | 6 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Sodium; Grade 1 | 117 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | ALT; Grade 3 | 2 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | LDL cholesterol calculation; Grade 2 | 16 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | ALT; Grade 4 | 0 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Phosphate; Grade 3 | 8 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Albumin; Grade 1 | 3 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | LDL cholesterol calculation; Grade 3 | 4 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Albumin; Grade 2 | 0 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Cholesterol; Grade 2 | 32 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Serum Triglycerides; Grade 1 | 0 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Albumin; Grade 3 | 0 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | LDL cholesterol calculation; Grade 4 | 0 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Albumin; Grade 4 | 0 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Phosphate; Grade 4 | 0 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | ALP; Grade 1 | 22 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | LDL cholesterol direct; Grade 1 | 8 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | ALP; Grade 2 | 1 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Sodium; Grade 2 | 2 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | ALP; Grade 3 | 1 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | LDL cholesterol direct; Grade 2 | 4 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | ALP; Grade 4 | 0 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Potassium; Grade 1 | 20 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | AST; Grade 1 | 18 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | LDL cholesterol direct; Grade 3 | 1 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | AST; Grade 2 | 4 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Cholesterol; Grade 1 | 46 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | AST; Grade 3 | 5 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Serum Triglycerides; Grade 3 | 3 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | AST; Grade 4 | 0 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Potassium; Grade 2 | 1 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Bilirubin; Grade 1 | 21 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Serum Triglycerides; Grade 4 | 2 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Bilirubin; Grade 2 | 11 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | LDL cholesterol direct; Grade 4 | 0 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Bilirubin; Grade 3 | 0 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Sodium; Grade 3 | 0 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Bilirubin; Grade 4 | 0 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Lipase; Grade 1 | 12 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | CO2; Grade 1 | 105 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Potassium; Grade 3 | 3 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Lipase; Grade 2 | 5 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | CO2; Grade 2 | 13 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Cholesterol; Grade 4 | 0 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | CO2; Grade 3 | 0 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | Lipase; Grade 3 | 1 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Clinical Chemistry Toxicities -Randomized Phase | CO2; Grade 4 | 0 Participants |
Secondary
Number of Participants With Disease Progression-Randomized + Continuation Phase
Disease progression included HIV-associated conditions, acquired immune deficiency syndrome (AIDS) and death. Number of participants with disease progression to Centers for Disease Control and Prevention (CDC) class C or death have been presented.
Time frame: Up to Week 348
Population: ITT-E Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Receiving DTG-Randomized Phase | Number of Participants With Disease Progression-Randomized + Continuation Phase | 10 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Disease Progression-Randomized + Continuation Phase | 7 Participants |
Secondary
Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Continuation Phase
Number of participants with fold change in treatment-emergent phenotypic resistance from Baseline to DTG was counted to assess the development of viral resistance. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Change in grade 0 to \>2 from Baseline is presented. Analysis was performed on Viral Phenotypic Continuation Population which comprises all participants in the ITT-E- Continuation Population with available on-treatment phenotypic resistance data in the Continuation Phase.
Time frame: Baseline (Day 1, Pre-dose) and up to Week 295
Population: Viral Phenotypic continuation Population. Only those participants with data available at specified time point were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Receiving DTG-Randomized Phase | Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Continuation Phase | DTG; <1 | 8 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Continuation Phase | DTG; 1-<2 | 3 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Continuation Phase | DTG; 2-<4 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Continuation Phase | DTG; 4-<8 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Continuation Phase | DTG; >=8 | 4 Participants |
Secondary
Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase
Number of participants with fold change in treatment-emergent phenotypic resistance from Baseline to DTG, LPV/RTV was counted to assess the development of viral resistance. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Change in grade 0 to \>2 from Baseline is presented. Analysis was performed on viral phenotypic Population, which comprised of all participants in the ITT-E Population with available On-treatment phenotypic resistance data at the time confirmed virologic withdrawal criterion is met during Randomized Phase.
Time frame: Baseline (Day 1, Pre-dose) and up to Week 52
Population: Viral Phenotypic Population. Only those participants with data available at specified time point were analyzed (represented by n=X) in category titles.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Receiving DTG-Randomized Phase | Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase | DTG; <1; n=11, 23 | 5 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase | DTG; 1-<2; n=11, 23 | 2 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase | DTG; 2-<4; n=11, 23 | 1 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase | DTG; 4-<8; n=11, 23 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase | DTG; >=8; n=11, 23 | 3 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase | LPV/RTV; <1; n=11, 29 | 7 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase | LPV/RTV; 1-<2; n=11, 29 | 4 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase | LPV/RTV; 2-<4; n=11, 29 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase | LPV/RTV; 4-<8; n=11, 29 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase | LPV/RTV; >=8; n=11, 29 | 0 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase | LPV/RTV; 2-<4; n=11, 29 | 0 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase | DTG; <1; n=11, 23 | 18 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase | LPV/RTV; <1; n=11, 29 | 21 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase | DTG; 1-<2; n=11, 23 | 5 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase | LPV/RTV; >=8; n=11, 29 | 0 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase | DTG; 2-<4; n=11, 23 | 0 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase | LPV/RTV; 1-<2; n=11, 29 | 8 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase | DTG; 4-<8; n=11, 23 | 0 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase | LPV/RTV; 4-<8; n=11, 29 | 0 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase | DTG; >=8; n=11, 23 | 0 Participants |
Secondary
Number of Participants With Hematology Toxicities-Continuation Phase
Number of participants with hematology toxicities has been presented. Toxicities were based on the Division of AIDS (DAIDS) grading system. Grade 1=Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for hematology parameters including Hemoglobin, Leukocytes, Neutrophils and Platelets.
Time frame: Up to Week 295
Population: Safety-Continuation Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Receiving DTG-Randomized Phase | Number of Participants With Hematology Toxicities-Continuation Phase | Hemoglobin; Grade 1 | 13 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Hematology Toxicities-Continuation Phase | Hemoglobin; Grade 2 | 2 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Hematology Toxicities-Continuation Phase | Hemoglobin; Grade 3 | 1 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Hematology Toxicities-Continuation Phase | Hemoglobin; Grade 4 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Hematology Toxicities-Continuation Phase | Leukocytes; Grade 1 | 23 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Hematology Toxicities-Continuation Phase | Leukocytes; Grade 2 | 6 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Hematology Toxicities-Continuation Phase | Leukocytes; Grade 3 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Hematology Toxicities-Continuation Phase | Leukocytes; Grade 4 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Hematology Toxicities-Continuation Phase | Neutrophils; Grade 1 | 21 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Hematology Toxicities-Continuation Phase | Neutrophils; Grade 2 | 16 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Hematology Toxicities-Continuation Phase | Neutrophils; Grade 3 | 10 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Hematology Toxicities-Continuation Phase | Neutrophils; Grade 4 | 2 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Hematology Toxicities-Continuation Phase | Platelets; Grade 1 | 6 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Hematology Toxicities-Continuation Phase | Platelets; Grade 2 | 3 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Hematology Toxicities-Continuation Phase | Platelets; Grade 3 | 1 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Hematology Toxicities-Continuation Phase | Platelets; Grade 4 | 0 Participants |
Secondary
Number of Participants With Hematology Toxicities -Randomized Phase
Number of participants with hematology toxicities has been presented. Toxicities were based on the Division of AIDS (DAIDS) grading system. Grade 1=Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for hematology parameters including Hemoglobin, Leukocytes, Neutrophils and Platelets.
Time frame: Up to Week 52
Population: Safety Population. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Receiving DTG-Randomized Phase | Number of Participants With Hematology Toxicities -Randomized Phase | Hemoglobin; Grade 1 | 6 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Hematology Toxicities -Randomized Phase | Hemoglobin; Grade 2 | 5 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Hematology Toxicities -Randomized Phase | Hemoglobin; Grade 3 | 5 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Hematology Toxicities -Randomized Phase | Hemoglobin; Grade 4 | 4 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Hematology Toxicities -Randomized Phase | Leukocytes; Grade 1 | 19 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Hematology Toxicities -Randomized Phase | Leukocytes; Grade 2 | 5 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Hematology Toxicities -Randomized Phase | Leukocytes; Grade 3 | 3 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Hematology Toxicities -Randomized Phase | Leukocytes; Grade 4 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Hematology Toxicities -Randomized Phase | Neutrophils; Grade 1 | 25 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Hematology Toxicities -Randomized Phase | Neutrophils; Grade 2 | 9 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Hematology Toxicities -Randomized Phase | Neutrophils; Grade 3 | 10 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Hematology Toxicities -Randomized Phase | Neutrophils; Grade 4 | 4 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Hematology Toxicities -Randomized Phase | Platelets; Grade 1 | 6 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Hematology Toxicities -Randomized Phase | Platelets; Grade 2 | 2 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Hematology Toxicities -Randomized Phase | Platelets; Grade 3 | 0 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Hematology Toxicities -Randomized Phase | Platelets; Grade 4 | 1 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Hematology Toxicities -Randomized Phase | Platelets; Grade 4 | 0 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Hematology Toxicities -Randomized Phase | Hemoglobin; Grade 1 | 18 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Hematology Toxicities -Randomized Phase | Neutrophils; Grade 1 | 26 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Hematology Toxicities -Randomized Phase | Hemoglobin; Grade 2 | 4 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Hematology Toxicities -Randomized Phase | Platelets; Grade 1 | 4 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Hematology Toxicities -Randomized Phase | Hemoglobin; Grade 3 | 0 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Hematology Toxicities -Randomized Phase | Neutrophils; Grade 2 | 11 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Hematology Toxicities -Randomized Phase | Hemoglobin; Grade 4 | 1 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Hematology Toxicities -Randomized Phase | Platelets; Grade 3 | 1 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Hematology Toxicities -Randomized Phase | Leukocytes; Grade 1 | 10 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Hematology Toxicities -Randomized Phase | Neutrophils; Grade 3 | 3 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Hematology Toxicities -Randomized Phase | Leukocytes; Grade 2 | 5 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Hematology Toxicities -Randomized Phase | Platelets; Grade 2 | 7 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Hematology Toxicities -Randomized Phase | Leukocytes; Grade 3 | 0 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Hematology Toxicities -Randomized Phase | Neutrophils; Grade 4 | 0 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Hematology Toxicities -Randomized Phase | Leukocytes; Grade 4 | 0 Participants |
Secondary
Number of Participants With Maximum Post-Baseline Emergent Grade 2 or Greater Drug-related Diarrhea
Number of participants who experienced maximum grade 2 or greater toxicity post-Baseline in drug-related diarrhea was summarized. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Participants were graded using the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening. Higher the grade, more severe the symptoms.
Time frame: Week 24 and Week 48
Population: Safety Population. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Receiving DTG-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Grade 2 or Greater Drug-related Diarrhea | Week 24 | 1 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Grade 2 or Greater Drug-related Diarrhea | Week 48 | 1 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Grade 2 or Greater Drug-related Diarrhea | Week 24 | 22 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Grade 2 or Greater Drug-related Diarrhea | Week 48 | 23 Participants |
Secondary
Number of Participants With Maximum Post-Baseline Emergent Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol
Blood samples were collected from participants in fasting state at indicated time-points to evaluate LDL cholesterol. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Number of participants who experienced maximum grade 2 or greater toxicity post-Baseline in fasting LDL cholesterol was summarized. Participants were graded using the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening. Higher the grade, more severe the symptoms.
Time frame: Up to Week 48
Population: Safety Population. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Receiving DTG-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol | 5 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Maximum Post-Baseline Emergent Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol | 20 Participants |
Secondary
Number of Participants With Non-serious Adverse Events (AEs) With >=2% Frequency Threshold and Serious Adverse Events (SAEs)-Randomized Phase
An AE is 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. SAE is defined as 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, or is a congenital anomaly/birth defect, other situations as per medical or scientific judgment and is associated with liver injury or impaired liver function. Safety Population was used which comprised of all participants who received at least one dose of study treatment. Adverse events which were not Serious were considered as Non-Serious adverse events.
Time frame: Up to Week 52
Population: Safety Population. Two participants who were randomized to receive LPV/RTV, received DTG and were included in DTG group for Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Receiving DTG-Randomized Phase | Number of Participants With Non-serious Adverse Events (AEs) With >=2% Frequency Threshold and Serious Adverse Events (SAEs)-Randomized Phase | Any non-serious AEs | 155 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Non-serious Adverse Events (AEs) With >=2% Frequency Threshold and Serious Adverse Events (SAEs)-Randomized Phase | Any SAEs | 20 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Non-serious Adverse Events (AEs) With >=2% Frequency Threshold and Serious Adverse Events (SAEs)-Randomized Phase | Any non-serious AEs | 202 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Non-serious Adverse Events (AEs) With >=2% Frequency Threshold and Serious Adverse Events (SAEs)-Randomized Phase | Any SAEs | 20 Participants |
Secondary
Number of Participants With Non-serious AEs With >=2% Frequency Threshold and SAEs-Continuation Phase
An AE is 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. SAE is defined as 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, or is a congenital anomaly/birth defect, other situations as per medical or scientific judgment and is associated with liver injury or impaired liver function. Adverse events which were not Serious were considered as non-serious AEs.
Time frame: Up to Week 295
Population: Safety-Continuation Population comprised all participants in the Safety Population who received at least one dose of Investigational Product after entering the Continuation Phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Receiving DTG-Randomized Phase | Number of Participants With Non-serious AEs With >=2% Frequency Threshold and SAEs-Continuation Phase | Any non-serious AEs | 150 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Non-serious AEs With >=2% Frequency Threshold and SAEs-Continuation Phase | Any SAEs | 29 Participants |
Secondary
Number of Participants With Non-serious AEs With >=2% Frequency Threshold and SAEs-Randomized + Continuation Phase
An AE is 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. SAE is defined as 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, or is a congenital anomaly/birth defect, other situations as per medical or scientific judgment and is associated with liver injury or impaired liver function. Adverse events which were not Serious were considered as non-serious AEs.
Time frame: Up to Week 348
Population: Safety Population. Two participants who were randomized to receive LPV/RTV, received DTG and were included in DTG group for Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Receiving DTG-Randomized Phase | Number of Participants With Non-serious AEs With >=2% Frequency Threshold and SAEs-Randomized + Continuation Phase | Any non-serious AEs | 218 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Non-serious AEs With >=2% Frequency Threshold and SAEs-Randomized + Continuation Phase | Any SAEs | 47 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Non-serious AEs With >=2% Frequency Threshold and SAEs-Randomized + Continuation Phase | Any non-serious AEs | 213 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Non-serious AEs With >=2% Frequency Threshold and SAEs-Randomized + Continuation Phase | Any SAEs | 20 Participants |
Secondary
Number of Participants With Treatment-emergent Genotypic Resistance-Continuation Phase
Number of participants, who met confirmed virologic withdrawal criteria with paired Baseline and time of CVW resistance data, with treatment emergent genotypic resistance to Integrase strand transfer inhibitor (INSTI), NRTI, Protease inhibitor (PI) were summarized. Analysis was performed on Viral Genotypic Continuation Population which comprised all participants in the ITT-E- Continuation Population with available on-treatment genotypic resistance data in the Continuation Phase.
Time frame: Up to Week 295
Population: Viral genotypic continuation Population. Only those participants with data available at specified time point were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Receiving DTG-Randomized Phase | Number of Participants With Treatment-emergent Genotypic Resistance-Continuation Phase | INSTI | 5 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Treatment-emergent Genotypic Resistance-Continuation Phase | NRTI | 2 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Treatment-emergent Genotypic Resistance-Continuation Phase | PI | 0 Participants |
Secondary
Number of Participants With Treatment-emergent Genotypic Resistance-Randomized Phase
Number of participants, who met confirmed virologic withdrawal (CVW) criteria with paired Baseline and time of CVW resistance data with treatment emergent genotypic resistance to Integrase strand transfer inhibitor (INSTI), NRTI, Protease inhibitor (PI) were summarized. Viral Genotypic Population comprised of all participants in the ITT-E population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met during Randomized Phase.
Time frame: Up to Week 52
Population: Viral genotypic Population. Only those participants with data available at specified time point were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Receiving DTG-Randomized Phase | Number of Participants With Treatment-emergent Genotypic Resistance-Randomized Phase | INSTI | 3 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Treatment-emergent Genotypic Resistance-Randomized Phase | NRTI | 1 Participants |
| Participants Receiving DTG-Randomized Phase | Number of Participants With Treatment-emergent Genotypic Resistance-Randomized Phase | PI | 0 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Treatment-emergent Genotypic Resistance-Randomized Phase | INSTI | 0 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Treatment-emergent Genotypic Resistance-Randomized Phase | NRTI | 3 Participants |
| Participants Receiving LPV/RTV-Randomized Phase | Number of Participants With Treatment-emergent Genotypic Resistance-Randomized Phase | PI | 0 Participants |
Secondary
Percentage of Participants Without Virologic or Tolerability Failure at Week 24 and Week 48
Virologic or tolerability failure was defined as treatment-related discontinuation (meeting confirmed virologic withdrawal criteria, treatment-related adverse event, safety stopping criteria, and lack of efficacy). Percentage of participants without virologic failure by Week 24 and Week 48 have been presented. Participants who did not met the protocol defined confirmed virologic withdrawal criteria and are ongoing in the study, or who had discontinued for non-treatment related reasons were censored.
Time frame: Week 24 and Week 48
Population: ITT-E Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants Receiving DTG-Randomized Phase | Percentage of Participants Without Virologic or Tolerability Failure at Week 24 and Week 48 | Week 24 | 97.6 Percentage of participants |
| Participants Receiving DTG-Randomized Phase | Percentage of Participants Without Virologic or Tolerability Failure at Week 24 and Week 48 | Week 48 | 96.0 Percentage of participants |
| Participants Receiving LPV/RTV-Randomized Phase | Percentage of Participants Without Virologic or Tolerability Failure at Week 24 and Week 48 | Week 24 | 91.9 Percentage of participants |
| Participants Receiving LPV/RTV-Randomized Phase | Percentage of Participants Without Virologic or Tolerability Failure at Week 24 and Week 48 | Week 48 | 86.1 Percentage of participants |
95% CI: [2.2, 9.3]
95% CI: [5.3, 14.4]
Secondary
Percentage of Participants With Plasma HIV-1 RNA <400 c/mL at Weeks 24 and 48
Percentage of participants with plasma HIV 1 RNA \<400 c/mL at Week 24 and 48 using the FDA snapshot algorithm were evaluated. Percentage values are rounded off.
Time frame: Week 24 and Week 48
Population: ITT-E Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants Receiving DTG-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <400 c/mL at Weeks 24 and 48 | Week 24 | 90 Percentage of participants |
| Participants Receiving DTG-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <400 c/mL at Weeks 24 and 48 | Week 48 | 88 Percentage of participants |
| Participants Receiving LPV/RTV-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <400 c/mL at Weeks 24 and 48 | Week 24 | 84 Percentage of participants |
| Participants Receiving LPV/RTV-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <400 c/mL at Weeks 24 and 48 | Week 48 | 77 Percentage of participants |
Secondary
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24
Percentage of participants with plasma HIV 1 RNA \<50 c/mL at Week 24 using the FDA snapshot algorithm was assessed to demonstrate the non-inferior activity of DTG plus 2 NRTI's compared to LPV/RTV plus 2 NRTI's. Percentage values are rounded off.
Time frame: Week 24
Population: ITT-E Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants Receiving DTG-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24 | 82 Percentage of participants |
| Participants Receiving LPV/RTV-Randomized Phase | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24 | 69 Percentage of participants |
Secondary
Time to Viral Suppression at Week 48
Viral suppression was defined as HIV-1 RNA \<50 c/mL. Time to viral suppression was analyzed and median and interquartile range has been presented.
Time frame: Week 48
Population: ITT-E Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants Receiving DTG-Randomized Phase | Time to Viral Suppression at Week 48 | 29.0 Days |
| Participants Receiving LPV/RTV-Randomized Phase | Time to Viral Suppression at Week 48 | 111.0 Days |