Management Using the Latest Technologies in Resource-limited Settings to Optimize Combination Therapy After Viral Failure (MULTI-OCTAVE)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 545
- 试验地点
- 19
- 主要终点
- Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 48 Weeks
研究概览
简要总结
The study was done to:
- test a strategy of using a resistance test to choose anti-HIV drugs
- see how well combinations of new anti-HIV drugs work to lower HIV infection
- see if taking new anti-HIV drugs together is safe and tolerable
- see if text messages improve people's anti-HIV drug-taking behavior (only at sites participating in the adherence study)
- in people taking certain combinations of anti-HIV drugs with an anti-TB drug, compare how these drugs act in the body
- to see how people do after they stop having frequent clinic visits as part of a research study
详细描述
A5288 was an open-label phase IV, prospective interventional, strategy study in resource-limited settings (RLS) for HIV-1 infected participants with triple-class experience or resistance to nucleoside reverse transcriptase inhibitors (NRTIs), non-NRTIs (NNRTIs), and protease inhibitors (PIs) and who were failing their current regimen. The use of novel agents and contemporary clinical decision management tools that include standard genotyping and plasma HIV viral load (VL) monitoring were evaluated. The screening genotype results and antiretroviral (ARV) history were used to allocate potential participants to one of four Cohorts (A, B, C or D) and to select an associated ARV regimen based on the Cohort assignment. In brief, individuals assigned to Cohort A continued on the same PI as in their second-line regimen, with the ability to modify NRTIs. Those assigned to Cohort B who were negative for hepatitis B were randomized to receive RAL and DRV/RTV with either the best available NRTIs (Cohort B1) or ETR (Cohort B2). If they were positive for hepatitis B they were assigned to Cohort B3 and received RAL, DRV/RTV and either FTC/TDF or 3TC/TDF. Individuals assigned to Cohort C received RAL and DRV/RTV with the best available NRTIs. Those ineligible for Cohorts A, B or C were assigned to Cohort D and received the best available regimen that included study provided drugs and any locally provided drugs.
At sites where feasible and relevant, the study evaluated an adherence support intervention. This involved a randomized comparison of a cell phone-based adherence support intervention plus local standard-of-care adherence support procedures (CPI+SOC) versus the SOC adherence support procedures.
Participants enrolled to the study in Step 1. If a participant experienced a confirmed virologic failure (defined as two consecutive HIV-1 RNA measures >= 1000 copies/mL) at/after 22 weeks on their Step 1 regimen, they had another genotype test performed and cohort/regimen selected for Step 2. With the exception of one additional visit 4 weeks after enrollment to Step 2, the visit schedule for Step 2 followed the participant's original Step 1 schedule throughout the remainder of follow up.
Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. During the first 48 weeks after Step 1 enrollment, clinic visits occurred at weeks 4, 12, 24, 36 and 48. After week 48, visits occurred every 12 weeks for adherence, safety and efficacy measures.
Participants had a final step 1/2 visit between November 22, 2016 and February 13, 2017. At the final step 1/2 visit, participants taking RAL, ETR, or DRV who were unable to obtain these drugs locally (e.g., through local treatment programs), and were otherwise eligible, entered Step 3 and continued to receive these drugs through the study for up to 96 additional weeks. Step 3 participants were dispensed ARVs every 12 weeks and had clinical assessments every 24 weeks. The purpose of Step 3 was to assist participants with the transition back to local care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort A
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
干预措施: Second line ART regimens - based on a boosted protease inhibitor (bPI) plus two nucleoside analogues (NRTIs) (Drug)
Cohort A
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
干预措施: SOC adherence versus SOC+CPI adherence (Other)
Sub-cohort B1
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening
• Best available NRTIs, RAL, & DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, & DRV/RTV
干预措施: Darunavir (Drug)
Sub-cohort B1
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening
• Best available NRTIs, RAL, & DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, & DRV/RTV
干预措施: Raltegravir (Drug)
Sub-cohort B1
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening
• Best available NRTIs, RAL, & DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, & DRV/RTV
干预措施: SOC adherence versus SOC+CPI adherence (Other)
Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening
• ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
干预措施: Darunavir (Drug)
Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening
• ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
干预措施: Etravirine (Drug)
Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening
• ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
干预措施: Raltegravir (Drug)
Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening
• ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
干预措施: SOC adherence versus SOC+CPI adherence (Other)
Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
干预措施: Darunavir (Drug)
Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
干预措施: Emtricitabine/tenofovir disoproxil fumarate (Drug)
Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
干预措施: Raltegravir (Drug)
Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
干预措施: SOC adherence versus SOC+CPI adherence (Other)
Cohort C
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV)
• Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
干预措施: Darunavir (Drug)
Cohort C
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV)
• Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
干预措施: Raltegravir (Drug)
Cohort C
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV)
• Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
干预措施: SOC adherence versus SOC+CPI adherence (Other)
Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
干预措施: Study provided drugs according to patient resistance profile (DRV, ETR, RTV, FTC/TDF) + any in country available drug as applicable & available (Drug)
Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
干预措施: SOC adherence versus SOC+CPI adherence (Other)
结局指标
主要结局
Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 48 Weeks
时间窗: 48 weeks after the date of entry
The measurement closest to exactly 48 weeks (ie, 7x48=336 days) after the date of entry, within the window of 48 weeks ± 6 weeks (specifically 295 to 378 days after randomization, inclusive). The analysis in the protocol and in the Stat. Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 48 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 48 was considered as HIV-1 RNA\>200 copies/mL at week 48. Missing results at week 48 were considered as HIV-1 RNA \>200 copies/mL at week 48 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL. Since the primary analysis was on the total study population, overall results were also submitted. All participants in B3 had HIV-1 RNA ≤200 copies/mL at week 48. Therefore, Wald confidence interval could not be computed for B3 and Clopper-Pearson Exact confidence interval is provided.
次要结局
- Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 24 Weeks(24 weeks after the date of entry)
- Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 72 Weeks(72 weeks after the date of entry)
- Percent of Participants With Confirmed Virologic Failure by Week 48(From week 24 to Week 48)
- Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing(From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks)
- Percent of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing, by Week 48(From week 24 to Week 48)
- Number of Weeks of Follow-up(From study entry through Step 1/2 follow-up)
- Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study(From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks)
- Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing(From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks)
- Time From Study Entry/Randomization to Death(From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks)
- Percent of Participants With Death or Hospitalization by Week 48(From study entry to Week 48)
- Percent of Participants With Confirmed Virologic Failure by Week 48 [CPI+SOC v SOC](From week 24 to Week 48)
- Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study(From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks)
- Percent of Participants Experiencing Death by Week 48(From study entry to Week 48)
- Percent of Participants That Developed Immune Reconstitution Inflammatory Syndrome (IRIS) by Week 48(From study entry to week 48)
- Percent of Participants With a Dose Modification Due to Grade 3 or 4 Toxicity by Week 48(From study entry to week 48)
- Change From Baseline in CD4+ T-cell Count(Baseline, week 24, 48, and 72)
- Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study [CPI+SOC v SOC](From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks)
- Time From Study Entry/Randomization to the First of Death, an AIDS-defining Event or a Non-AIDS-defining Event(From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks)
- Percent of Participants With Treatment Modification or Discontinuation by Week 48(From study entry to Week 48)
- Percent of Participants With Treatment Modification or Discontinuation Due to Toxicity by Week 48(From study entry to Week 48)
- Time From Study Entry/Randomization to the Development of Immune Reconstitution Inflammatory Syndrome (IRIS)(From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks)
- Time to First Dose Modification Due to Grade 3 or 4 Toxicity(From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks)
- Change From Baseline in Fasting Values of Glucose(Baseline, week 24, 48 and 72)
- Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 24 Weeks [CPI+SOC v SOC](24 weeks after the date of entry)
- Percent of Participants Experiencing Death, AIDS-defining Event or a Non-AIDS-defining Event by Week 48(From study entry to Week 48)
- Time From Study Entry/Randomization to Treatment Modification or Discontinuation.(From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks)
- Time From Study Entry/Randomization to Treatment Modification or Discontinuation Due to Toxicity(From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks)
- Change From Baseline in Fasting Values of Total Cholesterol(Baseline, week 24, 48 and 72)
- Change From Baseline in Fasting Values of High-density Lipoprotein Cholesterol(Baseline, week 24, 48 and 72)
- Change From Baseline in Fasting Values of Calculated Low-density Lipoprotein Cholesterol(Baseline, week 24, 48 and 72)
- Change From Baseline in Fasting Values of Triglycerides(Baseline, week 24, 48 and 72)
- Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 48 Weeks [CPI+SOC v SOC](48 weeks after the date of entry)
- Number of Weeks of Follow-up [CPI+SOC v SOC](From study entry through Step 1/2 follow-up)
- Time From Study Entry/Randomization to the First of Death or Hospitalization.(From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks)
- Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing [CPI+SOC v SOC](From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks)
- Time From Study Entry/Randomization to Death [CPI+SOC v SOC](From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks)
- Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 72 Weeks [CPI+SOC v SOC](72 weeks after the date of entry)
- Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing [CPI+SOC v SOC](From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks)
- Percent of Participants Experiencing Death by Week 48 [CPI+SOC v SOC](From study entry to Week 48)
- Time From Study Entry/Randomization to Treatment Modification or Discontinuation [CPI+SOC v SOC](From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks)
- Time From Study Entry/Randomization to the Development of Immune Reconstitution Inflammatory Syndrome (IRIS) [CPI+SOC v SOC](From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks)
- Time to First Dose Modification Due to Grade 3 or 4 Toxicity [CPI+SOC v SOC](From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks)
- Percent of Participants With a Dose Modification Due to Grade 3 or 4 Toxicity by Week 48 [CPI+SOC v SOC](From study entry to Week 48)
- Change From Baseline in Fasting Values of High-density Lipoprotein Cholesterol [CPI+SOC v SOC](Baseline, week 24, 48, and 72)
- Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study [CPI+SOC v SOC](From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks)
- Time From Study Entry/Randomization to the First of Death, an AIDS-defining Event or a Non-AIDS-defining Event [CPI+SOC v SOC](From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks)
- Time From Study Entry/Randomization to the First of Death or Hospitalization [CPI+SOC v SOC](From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks)
- Percent of Participants With Treatment Modification or Discontinuation by Week 48 [CPI+SOC v SOC](From study entry to Week 48)
- Change From Baseline in Fasting Values of Total Cholesterol [CPI+SOC v SOC](Baseline, week 24, 48, and 72)
- Percent of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing, by Week 48 [CPI+SOC v SOC](From week 24 to Week 48)
- Percent of Participants Experiencing Death, AIDS-defining Event or a Non-AIDS-defining Event by Week 48 [CPI+SOC v SOC](From study entry to Week 48)
- Time From Study Entry/Randomization to Treatment Modification or Discontinuation Due to Toxicity [CPI+SOC v SOC](From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks)
- Change From Baseline in CD4+ T-cell Count [CPI+SOC v SOC](Baseline, week 24, 48, and 72)
- Change From Baseline in Fasting Values of Glucose [CPI+SOC v SOC](Baseline, week 24, 48, and 72)
- Percent of Participants With Death or Hospitalization by Week 48 [CPI+SOC v SOC](From study entry to Week 48)
- Percent of Participants With Treatment Modification or Discontinuation Due to Toxicity by Week 48 [CPI+SOC v SOC](From study entry to Week 48)
- Percent of Participants That Developed Immune Reconstitution Inflammatory Syndrome (IRIS) by Week 48 [CPI+SOC v SOC](From study entry to Week 48)
- Change From Baseline in Fasting Values of Calculated Low-density Lipoprotein Cholesterol [CPI+SOC v SOC](Baseline, week 24, 48, and 72)
- Change From Baseline in Fasting Values of Triglycerides [CPI+SOC v SOC](Baseline, week 24, 48, and 72)