HIV Infection
Conditions
Keywords
HIV, HIV 1
Brief summary
This protocol describes a prospective, randomized, open-label, multicenter study to evaluate the safety and efficacy of switching from fixed dose abacavir (ABC)/lamivudine (3TC) to fixed dose emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) in virologically suppressed, human immunodeficiency virus type 1 (HIV-1) infected subjects maintained on a ritonavir-boosted protease inhibitor (PI/r)-containing antiretroviral (ARV) regimen. Duration of treatment is 48 weeks.
Detailed description
This protocol describes a prospective, randomized, open-label, multicenter study to evaluate the safety and efficacy of switching from fixed dose ABC/3TC to fixed dose FTC/TDF in virologically suppressed, HIV-1 infected subjects maintained on a PI/r-containing ARV regimen. Subjects were stratified based on the PI/r (ie, lopinavir/ritonavir \[LPV/r\] versus other boosted PIs) in their regimen, and the presence versus absence of comorbidities at screening (diabetes mellitus or cardiovascular disease such as hypertension, coronary artery disease, hyperlipidemia, history of myocardial infarction, cardiomyopathy, valvular heart disease, congenital heart disease, stroke, peripheral vascular disease, or arrhythmias). Subjects were randomized 1:1 to switch to FTC/TDF+PI/r or to continue on their existing regimen. Subjects received study treatment for 48 weeks.
Interventions
DRUGemtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)
FTC 200 mg/TDF 300 mg tablet, once a day
DRUGabacavir (ABC)/lamivudine (3TC)
ABC 600 mg/3TC 300 mg tablet, once a day
Sponsors
Gilead Sciences
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
* Adult (greater than or equal to 18 years) males or non-pregnant, non-lactating females * HIV-1 infected subjects currently receiving a ritonavir-boosted protease inhibitor and fixed-dose ABC/3TC regimen continuously for greater than or equal to 3 months * HIV infection as documented by a validated HIV antibody enzyme-linked immunosorbent assay (ELISA) and confirmed by one of the following: * Immunoblot detection of HIV antibody * Positive HIV-1 blood culture * Positive HIV-1 serum P24 antigen * HIV-1 plasma viremia greater than 1000 copies/mL by polymerase chain reaction (PCR) or branched-chain deoxyribonucleic acid (bDNA) method * Detection of proviral DNA by PCR (If confirmation of HIV infection is not available then repeat testing of HIV antibody will be required) * Two consecutive plasma HIV-1 RNA concentration less than 200 copies/mL. The two HIV-1 RNA determinations ensure that the subject has been virologically-suppressed for at least 3 months prior to study entry: * The subject must have a plasma HIV-1 RNA level less than 200 copies/mL using the AmpliPrep/Taqman HIV-1 Test or Roche Amplicor HIV-1 Monitor Test Version 1.5 Ultrasensitive method at least 3 months prior to the screening visit, as the qualifying HIV-1 RNA. * HIV-1 RNA less than 200 copies/mL measured by bDNA (Chiron 3.0) may be used as a qualifying HIV-1 RNA for entry to the study but not for the confirmatory HIV-1 RNA. * The subject must have a confirmed second plasma HIV-1 RNA less than 200 copies/mL at screening, as the confirmatory HIV-1 RNA. * The subject must not have a plasma HIV-1 RNA greater than or equal to 200 copies/mL between the qualifying and confirmatory HIV-1 RNA measurements. * Subjects receiving lipid-lowering agents (LLA) will be allowed; however, LLAs must be stable for greater than or equal to 3 months prior to study entry. * Adequate renal function defined as a calculated CLcr greater than or equal to 50 mL/min according to the Cockcroft-Gault formula * Negative serum pregnancy test (females of childbearing potential only) * Hepatic transaminases alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 5 X upper limit of normal * Males and females (of childbearing potential, ie, a non-menopausal female or a female with menopause \< 2 years, and who has not had a hysterectomy, bilateral oophorectomy, or medically documented ovarian failure; this definition includes a young woman who has not yet started menstruating), and must agree to avoid pregnancy by sexual abstinence, or utilization of a highly effective method of birth control throughout the study period and for 30 days following discontinuation of study drug * The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures
Exclusion criteria
* Subjects receiving ABC/3TC and a PI without ritonavir * Subjects receiving other ARV agents (eg, 2 protease inhibitors boosted with low-dose ritonavir (ie, double-boosted PI regimens), nonnucleoside reverse transcriptase inhibitors \[NNRTIs\], integrase inhibitors, TDF, or other nucleoside reverse transcriptase inhibitor \[NRTIs\]) in addition to ABC/3TC and a ritonavir-boosted protease inhibitor * Have known resistance to any of the study agents at any time in the past including NRTI resistance mutations (including but not limited to K65R, L74V/I, M184V/I, or thymidine analog mutations) and/or PI resistance mutations * A new acquired immunodeficiency syndrome (AIDS) defining condition diagnosed (with the exception of CD4 criteria) within 30 days of baseline * Previous therapy with agents with systemic myelosuppressive, pancreatoxic, hepatotoxic or cytotoxic potential within 3 months of study start or the expected need for such therapy at the time of enrollment * Proven or suspected acute hepatitis in the 30 days prior to study entry * Anticipated need to initiate drugs during the study that are contraindicated with protease inhibitors (except upon approval by Gilead) * Receiving ongoing therapy with any of the following (administration of any of the following medications must be discontinued at least 30 days prior to the Baseline visit and for the duration of the study period): * Nephrotoxic agents (aminoglycoside antibiotics, amphotericin B, cidofovir, cisplatin, foscarnet, intravenous pentamidine, other agents with significant nephrotoxic potential) * Adefovir dipivoxil * Probenecid * Systemic chemotherapeutic agents (ie, cancer treatment medications) * Systemic corticosteroids * Interleukin-2 (IL-2) * Investigational agents (except upon approval by Gilead) * Pregnant or lactating subjects * Evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting which may confer an inability to receive an orally administered medication * Current alcohol or substance abuse judged by the investigator to potentially interfere with subject adherence * Malignancy other than cutaneous Kaposi's sarcoma (KS) or basal cell carcinoma. Subjects with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of baseline and are not anticipated to require systemic therapy during the study. * Active, serious infections (other than HIV-1 infection) requiring parenteral antimicrobial therapy within 15 days prior to screening * Prior history of significant renal or bone disease * Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements * Known hypersensitivity to the study drugs, the metabolites or formulation excipients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) < 200 Copies/mL Through Week 48 Based on Time to Loss of Virologic Response (TLOVR) Algorithm | Baseline to 48 weeks | The percentage of participants with HIV-1 RNA \< 200 copies/mL based on TLOVR algorithm at Week 48 was summarized. Participants were considered nonresponders in the TLOVR analysis if they experienced virologic rebound prior to or at Week 48, discontinued study before Week 48, or added a new antiretroviral (ARV) agent prior to completion of the study. Virologic rebound was defined as 2 consecutive HIV-1 RNA values \>= 200 copies/mL or the last HIV-1 RNA value \>= 200 copies/mL followed by discontinuation from the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 200 Copies/mL Through Week 48 | Baseline to 48 weeks | The percentage of participants with PVR for HIV-1 RNA cutoff at 200 copies/mL at Week 48 was summarized. Pure virologic response was the percentage of subjects who did not have a virologic rebound. Virologic rebound was defined as two consecutive HIV-1 RNA values \>= 200 copies/mL or the last HIV-1 RNA value \>= 200 copies/mL followed by discontinuation from the study. |
| Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 50 Copies/mL Through Week 48 | Baseline to 48 weeks | The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 48 was summarized. Pure virologic response was the proportion of participants who did not have a virologic rebound. Virologic rebound was defined as two consecutive HIV-1 RNA values \>= 50 copies/mL or the last HIV-1 RNA value \>= 50 copies/mL followed by discontinuation from the study. |
| Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48 | 48 weeks | The percentage of participants with HIV-1 RNA \< 200 copies/mL at Week 48 was summarized. |
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 | 48 weeks | The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was summarized. |
| Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48 | Baseline to 48 weeks | Change = Week 48 value minus baseline value |
| Change From Baseline Calculated Creatinine Clearance (CLcr) Using Ideal Body Weight by Cockcroft-Gault Method at Week 48 | Baseline to 48 weeks | Change = Week 48 value minus baseline value |
| Change From Baseline Estimated Glomerular Filtration Rate (eGFR) by Modified Diet in Renal Disease (MDRD) at Week 48 | Baseline to 48 weeks | Change = Week 48 value minus baseline value |
| Change From Baseline Fasting Glucose at Week 48 | Baseline to 48 weeks | Change = Week 48 value minus baseline value |
| Change From Baseline Fasting Lipid Parameters at Week 48 | Baseline to 48 weeks | Change = Week 48 value minus baseline value |
| Change From Baseline Ratio of Fasting Total Cholesterol Over High-density Lipoprotein (HDL) Cholesterol at Week 48 | Baseline to 48 weeks | Change = Week 48 value minus baseline value |
| Change From Baseline C-Reactive Protein at Week 48 | Baseline to 48 weeks | Change = Week 48 value minus baseline value |
| Change From Baseline Fibrinogen at Week 48 | Baseline to 48 weeks | Change = Week 48 value minus baseline value |
| Change From Baseline Interleukin-6 (IL-6), Interleukin-10 (IL-10), and Tumor Necrosis Factor-alpha (TNF-alpha) at Week 48 | Baseline to 48 weeks | Change = Week 48 value minus baseline value |
Countries
Canada, Puerto Rico, United States
Participant flow
Recruitment details
Participants were enrolled at a total of 76 study sites; 70 in the US, 3 in Canada, and 3 in Puerto Rico. The first participant was screened on 15 August 2008, and the last participant was randomized on 27 April 2010. Last participant observation (LPO) date was 19 April 2011
Pre-assignment details
A total of 393 subjects were screened for entry into this study, and 312 subjects were randomized (156 to each treatment group). One participant randomized to the TVD+PI/r group was never treated.
Participants by arm
| Arm | Count |
|---|---|
| TVD + PI/r Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada \[TVD\]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study. | 155 |
| ABC/3TC + PI/r Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks. | 156 |
| Total | 311 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 7 | 3 |
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Lost to Follow-up | 4 | 5 |
| Overall Study | Physician Decision | 0 | 3 |
| Overall Study | Pregnancy | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 4 |
Baseline characteristics
| Characteristic | ABC/3TC + PI/r | TVD + PI/r | Total |
|---|---|---|---|
| Age Continuous | 47 years STANDARD_DEVIATION 9.7 | 46 years STANDARD_DEVIATION 9 | 46 years STANDARD_DEVIATION 9.3 |
| Body Mass Index (BMI) | 27.2 kg/m^2 STANDARD_DEVIATION 4.93 | 27.3 kg/m^2 STANDARD_DEVIATION 5.96 | 27.3 kg/m^2 STANDARD_DEVIATION 5.46 |
| Height | 174.1 cm STANDARD_DEVIATION 9.55 | 173.8 cm STANDARD_DEVIATION 9.52 | 173.9 cm STANDARD_DEVIATION 9.52 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Asian | 3 participants | 4 participants | 7 participants |
| Race/Ethnicity, Customized Black or African American | 44 participants | 43 participants | 87 participants |
| Race/Ethnicity, Customized Hispanic/Latino | 36 participants | 38 participants | 74 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Non-Hispanic/Latino | 120 participants | 117 participants | 237 participants |
| Race/Ethnicity, Customized Other | 3 participants | 12 participants | 15 participants |
| Race/Ethnicity, Customized White | 106 participants | 96 participants | 202 participants |
| Region of Enrollment Canada | 9 participants | 5 participants | 14 participants |
| Region of Enrollment Puerto Rico | 5 participants | 4 participants | 9 participants |
| Region of Enrollment United States | 142 participants | 146 participants | 288 participants |
| Sex: Female, Male Female | 22 Participants | 26 Participants | 48 Participants |
| Sex: Female, Male Male | 134 Participants | 129 Participants | 263 Participants |
| Weight | 82.5 kg STANDARD_DEVIATION 15.65 | 82.2 kg STANDARD_DEVIATION 17.4 | 82.3 kg STANDARD_DEVIATION 16.52 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 35 / 155 | 32 / 156 |
| serious Total, serious adverse events | 12 / 155 | 11 / 156 |
Outcome results
Primary
Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) < 200 Copies/mL Through Week 48 Based on Time to Loss of Virologic Response (TLOVR) Algorithm
The percentage of participants with HIV-1 RNA \< 200 copies/mL based on TLOVR algorithm at Week 48 was summarized. Participants were considered nonresponders in the TLOVR analysis if they experienced virologic rebound prior to or at Week 48, discontinued study before Week 48, or added a new antiretroviral (ARV) agent prior to completion of the study. Virologic rebound was defined as 2 consecutive HIV-1 RNA values \>= 200 copies/mL or the last HIV-1 RNA value \>= 200 copies/mL followed by discontinuation from the study.
Time frame: Baseline to 48 weeks
Population: Intent-to-treat (ITT) Analysis Set: Participants who were treated with at least one dose of study drug with no documented resistance to study drug prior to screening.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TVD + PI/r | Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) < 200 Copies/mL Through Week 48 Based on Time to Loss of Virologic Response (TLOVR) Algorithm | 86.4 percentage of participants |
| ABC/3TC + PI/r | Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) < 200 Copies/mL Through Week 48 Based on Time to Loss of Virologic Response (TLOVR) Algorithm | 83.3 percentage of participants |
Comparison: Null hypothesis: The TVD group is at least 12% worse than the ABC/3TC group with respect to the percentage of subjects maintaining HIV-1 RNA \< 200 copies/mL through Week 48 (responder rate, as defined by the TLOVR algorithm)~Alternative hypothesis: The TVD group is less than 12% worse than the ABC/3TC group with respect to the percentage of subjects maintaining HIV-1 RNA \< 200 copies/mL through Week 48 (responder rate, as defined by the TLOVR algorithm)95% CI: [-5.1, 11.2]Inverted two one-sided tests
Secondary
Change From Baseline Calculated Creatinine Clearance (CLcr) Using Ideal Body Weight by Cockcroft-Gault Method at Week 48
Change = Week 48 value minus baseline value
Time frame: Baseline to 48 weeks
Population: Treated Analysis Set: The treated analysis set included all randomized participants who received at least one dose of study drug. Participants who were randomized to continue ABC/3TC+PI/r during the study were included in the treated analysis set if they took at least one dose of their study drug after the baseline visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TVD + PI/r | Change From Baseline Calculated Creatinine Clearance (CLcr) Using Ideal Body Weight by Cockcroft-Gault Method at Week 48 | -8.4 mL/min | Standard Deviation 12.18 |
| ABC/3TC + PI/r | Change From Baseline Calculated Creatinine Clearance (CLcr) Using Ideal Body Weight by Cockcroft-Gault Method at Week 48 | -4.1 mL/min | Standard Deviation 12.99 |
Secondary
Change From Baseline C-Reactive Protein at Week 48
Change = Week 48 value minus baseline value
Time frame: Baseline to 48 weeks
Population: Treated Analysis Set, Subset of Subjects Enrolled after Amendment 3~Missing = Excluded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TVD + PI/r | Change From Baseline C-Reactive Protein at Week 48 | -0.026 mg/dL | Standard Deviation 0.4029 |
| ABC/3TC + PI/r | Change From Baseline C-Reactive Protein at Week 48 | 0.225 mg/dL | Standard Deviation 1.2787 |
Secondary
Change From Baseline Estimated Glomerular Filtration Rate (eGFR) by Modified Diet in Renal Disease (MDRD) at Week 48
Change = Week 48 value minus baseline value
Time frame: Baseline to 48 weeks
Population: Treated Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TVD + PI/r | Change From Baseline Estimated Glomerular Filtration Rate (eGFR) by Modified Diet in Renal Disease (MDRD) at Week 48 | -9.0 mL/min/1.73m^2 | Standard Deviation 14.1 |
| ABC/3TC + PI/r | Change From Baseline Estimated Glomerular Filtration Rate (eGFR) by Modified Diet in Renal Disease (MDRD) at Week 48 | -3.7 mL/min/1.73m^2 | Standard Deviation 15.75 |
Secondary
Change From Baseline Fasting Glucose at Week 48
Change = Week 48 value minus baseline value
Time frame: Baseline to 48 weeks
Population: Treated Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TVD + PI/r | Change From Baseline Fasting Glucose at Week 48 | 1 mg/dL | Standard Deviation 23.1 |
| ABC/3TC + PI/r | Change From Baseline Fasting Glucose at Week 48 | 1 mg/dL | Standard Deviation 16.8 |
Secondary
Change From Baseline Fasting Lipid Parameters at Week 48
Change = Week 48 value minus baseline value
Time frame: Baseline to 48 weeks
Population: Treated Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TVD + PI/r | Change From Baseline Fasting Lipid Parameters at Week 48 | Total Cholesterol | -21 mg/dL | Standard Deviation 38.6 |
| TVD + PI/r | Change From Baseline Fasting Lipid Parameters at Week 48 | LDL (low-density lipoprotein) | -6 mg/dL | Standard Deviation 33.2 |
| TVD + PI/r | Change From Baseline Fasting Lipid Parameters at Week 48 | HDL (high-density lipoprotein) | -2 mg/dL | Standard Deviation 10.7 |
| TVD + PI/r | Change From Baseline Fasting Lipid Parameters at Week 48 | Triglycerides | -51 mg/dL | Standard Deviation 174 |
| ABC/3TC + PI/r | Change From Baseline Fasting Lipid Parameters at Week 48 | Triglycerides | -23 mg/dL | Standard Deviation 178.3 |
| ABC/3TC + PI/r | Change From Baseline Fasting Lipid Parameters at Week 48 | Total Cholesterol | -4 mg/dL | Standard Deviation 37.9 |
| ABC/3TC + PI/r | Change From Baseline Fasting Lipid Parameters at Week 48 | HDL (high-density lipoprotein) | 0 mg/dL | Standard Deviation 11.3 |
| ABC/3TC + PI/r | Change From Baseline Fasting Lipid Parameters at Week 48 | LDL (low-density lipoprotein) | 2 mg/dL | Standard Deviation 30 |
Secondary
Change From Baseline Fibrinogen at Week 48
Change = Week 48 value minus baseline value
Time frame: Baseline to 48 weeks
Population: Treated Analysis Set, Subset of Subjects Enrolled after Amendment 3~Missing = Excluded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TVD + PI/r | Change From Baseline Fibrinogen at Week 48 | -4 mg/dL | Standard Deviation 77 |
| ABC/3TC + PI/r | Change From Baseline Fibrinogen at Week 48 | 14 mg/dL | Standard Deviation 91.8 |
Secondary
Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48
Change = Week 48 value minus baseline value
Time frame: Baseline to 48 weeks
Population: ITT Analysis Set~Missing = Excluded: Participants with missing values were excluded from this analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TVD + PI/r | Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48 | 8 cells/microliter | Standard Deviation 148.3 |
| ABC/3TC + PI/r | Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48 | 34 cells/microliter | Standard Deviation 150.1 |
Secondary
Change From Baseline Interleukin-6 (IL-6), Interleukin-10 (IL-10), and Tumor Necrosis Factor-alpha (TNF-alpha) at Week 48
Change = Week 48 value minus baseline value
Time frame: Baseline to 48 weeks
Population: Treated Analysis Set, Subset of Participants Enrolled after Amendment 3~Missing = Excluded
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TVD + PI/r | Change From Baseline Interleukin-6 (IL-6), Interleukin-10 (IL-10), and Tumor Necrosis Factor-alpha (TNF-alpha) at Week 48 | IL-10 | 0.0 pg/mL | Standard Deviation 1.69 |
| TVD + PI/r | Change From Baseline Interleukin-6 (IL-6), Interleukin-10 (IL-10), and Tumor Necrosis Factor-alpha (TNF-alpha) at Week 48 | IL-6 | -0.2 pg/mL | Standard Deviation 4.1 |
| TVD + PI/r | Change From Baseline Interleukin-6 (IL-6), Interleukin-10 (IL-10), and Tumor Necrosis Factor-alpha (TNF-alpha) at Week 48 | TNF-alpha | 0.0 pg/mL | Standard Deviation 2.06 |
| ABC/3TC + PI/r | Change From Baseline Interleukin-6 (IL-6), Interleukin-10 (IL-10), and Tumor Necrosis Factor-alpha (TNF-alpha) at Week 48 | IL-10 | -0.2 pg/mL | Standard Deviation 1.41 |
| ABC/3TC + PI/r | Change From Baseline Interleukin-6 (IL-6), Interleukin-10 (IL-10), and Tumor Necrosis Factor-alpha (TNF-alpha) at Week 48 | IL-6 | -0.6 pg/mL | Standard Deviation 5.96 |
| ABC/3TC + PI/r | Change From Baseline Interleukin-6 (IL-6), Interleukin-10 (IL-10), and Tumor Necrosis Factor-alpha (TNF-alpha) at Week 48 | TNF-alpha | 4.7 pg/mL | Standard Deviation 23.95 |
Secondary
Change From Baseline Ratio of Fasting Total Cholesterol Over High-density Lipoprotein (HDL) Cholesterol at Week 48
Change = Week 48 value minus baseline value
Time frame: Baseline to 48 weeks
Population: Treated Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TVD + PI/r | Change From Baseline Ratio of Fasting Total Cholesterol Over High-density Lipoprotein (HDL) Cholesterol at Week 48 | -0.1 Ratio | Standard Deviation 2.58 |
| ABC/3TC + PI/r | Change From Baseline Ratio of Fasting Total Cholesterol Over High-density Lipoprotein (HDL) Cholesterol at Week 48 | -0.1 Ratio | Standard Deviation 1.03 |
Secondary
Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48
The percentage of participants with HIV-1 RNA \< 200 copies/mL at Week 48 was summarized.
Time frame: 48 weeks
Population: ITT analysis set~Missing = Failure: Participants with missing values considered to have HIV-1 RNA levels \>= 200 copies/mL~Virologic Success: Last available HIV-1 RNA \< 200 copies/mL in the Week 48 window while on randomized treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TVD + PI/r | Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48 | On-Treatment Response Analysis (Missing = Failure) | 84.4 percentage of participants |
| TVD + PI/r | Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48 | Snapshot Responder Analysis (Virologic Success) | 84.4 percentage of participants |
| ABC/3TC + PI/r | Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48 | On-Treatment Response Analysis (Missing = Failure) | 82.1 percentage of participants |
| ABC/3TC + PI/r | Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48 | Snapshot Responder Analysis (Virologic Success) | 82.1 percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was summarized.
Time frame: 48 weeks
Population: ITT analysis set~TLOVR: No virologic rebound on or before Week 48; no discontinuation before Week 48; no new ARV by study completion~Missing = Failure: Participants with missing values considered to have HIV-1 RNA levels \>= 50 copies/mL~Virologic Success: Last available HIV-1 RNA \< 50 copies/mL in Week 48 window on randomized treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TVD + PI/r | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 | TLOVR Responder Analysis | 77.9 percentage of participants |
| TVD + PI/r | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 | On-Treatment Response Analysis (Missing = Failure) | 79.9 percentage of participants |
| TVD + PI/r | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 | Snapshot Responder Analysis (Virologic Success) | 79.9 percentage of participants |
| ABC/3TC + PI/r | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 | TLOVR Responder Analysis | 76.3 percentage of participants |
| ABC/3TC + PI/r | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 | On-Treatment Response Analysis (Missing = Failure) | 77.6 percentage of participants |
| ABC/3TC + PI/r | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 | Snapshot Responder Analysis (Virologic Success) | 77.6 percentage of participants |
Secondary
Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 200 Copies/mL Through Week 48
The percentage of participants with PVR for HIV-1 RNA cutoff at 200 copies/mL at Week 48 was summarized. Pure virologic response was the percentage of subjects who did not have a virologic rebound. Virologic rebound was defined as two consecutive HIV-1 RNA values \>= 200 copies/mL or the last HIV-1 RNA value \>= 200 copies/mL followed by discontinuation from the study.
Time frame: Baseline to 48 weeks
Population: ITT Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TVD + PI/r | Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 200 Copies/mL Through Week 48 | 99.2 percentage of participants |
| ABC/3TC + PI/r | Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 200 Copies/mL Through Week 48 | 97.2 percentage of participants |
Secondary
Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 50 Copies/mL Through Week 48
The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 48 was summarized. Pure virologic response was the proportion of participants who did not have a virologic rebound. Virologic rebound was defined as two consecutive HIV-1 RNA values \>= 50 copies/mL or the last HIV-1 RNA value \>= 50 copies/mL followed by discontinuation from the study.
Time frame: Baseline to 48 weeks
Population: ITT Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TVD + PI/r | Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 50 Copies/mL Through Week 48 | 93.0 percentage of participants |
| ABC/3TC + PI/r | Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 50 Copies/mL Through Week 48 | 91.1 percentage of participants |