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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01AI068636 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| AbbVie | INDUSTRY |
| Gilead Sciences | INDUSTRY |
| Janssen Pharmaceuticals |
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The study was done to:
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.
The primary analysis specified in the protocol and in the Statistical Analysis Plan was to estimate the proportion of participants in the overall study population who were virologically suppressed (HIV-1 RNA ≤200 copies/mL) at week 48 with a 95% confidence interval.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | 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. |
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| Sub-cohort B1 | Experimental | 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 |
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| Sub-cohort B2 | Experimental | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Darunavir | Drug | Participants were administered darunavir orally as one 600 mg tablet twice a day (1200 mg per day) with food (taken with Ritonavir 100 mg twice a day [200 mg per day]) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 48 Weeks | 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. | 48 weeks after the date of entry |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 24 Weeks | The measurement closest to exactly 24 weeks (ie, 7x24=168 days) after the date of entry, within the window of 24 weeks ± 6 weeks (specifically 127 to 210 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 24 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 24 was considered as HIV-1 RNA>200 copies/mL at week 24. Missing results at week 24 were considered as HIV-1 RNA >200 copies/mL at week 24 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 24. Therefore, Wald confidence interval could not be computed for B3 and Clopper-Pearson Exact confidence interval is provided. |
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Inclusion Criteria for Step 1:
NOTE: All potential participants with prior RAL exposure were assigned to either Cohort A or Cohort D.
At screening, receipt of a PI-based regimen with no regimen change for a minimum of 24 weeks prior to screening.
Confirmation of VF of current second-line PI-based ART. NOTE A: Failure of the current second-line regimen was defined as two consecutive measurements of plasma HIV-1 RNA ≥1000 copies/mL obtained at least 1 day apart while on the current PI-based regimen. "Current PI-based regimen" and "current regimen" were understood to be the regimen described (ie, the regimen that the candidate was taking when the first VF sample was drawn plus only those modifications allowed).
CD4+ T-cell count result from a specimen drawn within 103 days prior to study entry
Laboratory values obtained within 30 days prior to study entry:
NOTE A: Candidates who were eligible for cohort B and who were positive for active hepatitis B infection were assigned to sub-cohort B3 at registration/randomization.
NOTE B: Candidates with CrCl <60 mL/min who were also positive for active hepatitis B infection were not eligible.
Acceptable forms of contraceptives included:
Female participants who were not of reproductive potential or whose male partner(s) had documented azoospermia) were not required to use contraceptives. Any statement of self-reported sterility or that of her partner's must have been entered in the source documents.
NOTE: Acceptable documentation of lack of reproductive potential was oral or written documentation from the participant.
Exclusion Criteria for Step 1:
NOTE: Study candidates should not have discontinued any component of their ART during screening. The 14-day restriction on prohibited medications did not apply to ARVs.
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| Name | Affiliation | Role |
|---|---|---|
| Beatriz Grinsztejn, MD, PhD | Instituto de Pesquisa Clinica Evandro Chagas-Fiocruz | Study Chair |
| Peter Mugyenyi, MB ChB, FRCP, DSc | Joint Clinical Research Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Nossa Senhora da Conceicao CRS (12201) | Porto Alegre | Rio Grande do Sul | 9043010 | Brazil | ||
| Instituto de Pesquisa Clinica Evandro Chagas (12101) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36039892 | Derived | Avihingsanon A, Hughes MD, Salata R, Godfrey C, McCarthy C, Mugyenyi P, Hogg E, Gross R, Cardoso SW, Bukuru A, Makanga M, Badal-Aesen S, Mave V, Ndege BW, Fontain SN, Samaneka W, Secours R, Van Schalkwyk M, Mngqibisa R, Mohapi L, Valencia J, Sugandhavesa P, Montalban E, Munyanga C, Chagomerana M, Santos BR, Kumarasamy N, Kanyama C, Schooley RT, Mellors JW, Wallis CL, Collier AC, Grinsztejn B; A5288 Study team. Third-line antiretroviral therapy, including raltegravir (RAL), darunavir (DRV/r) and/or etravirine (ETR), is well tolerated and achieves durable virologic suppression over 144 weeks in resource-limited settings: ACTG A5288 strategy trial. J Int AIDS Soc. 2022 Jun;25(6):e25905. doi: 10.1002/jia2.25905. | |
| 32049773 |
| Label | URL |
|---|---|
| DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004; Clarification, August 2009 | View source |
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Participants were enrolled between 22FEB2013 and 21DEC2015 at non-US based clinical research sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: 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. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Cohorts |
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| INDUSTRY |
| Merck Sharp & Dohme LLC | INDUSTRY |
| Dimagi Inc. | INDUSTRY |
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| Sub-cohort B3 | Experimental | 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 |
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| Cohort C | Experimental | 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 |
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| Cohort D | Experimental | 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 |
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| Etravirine | Drug | Patients were administered Etravirine orally as two 100 mg tablets or one 200 mg tablet twice a day (400 mg per day) following a meal. |
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| Emtricitabine/tenofovir disoproxil fumarate | Drug | Patients were administered FTC/TDF orally as one fixed dose combination tablet (FTC 200 mg/TDF 300 mg) once daily, with or without food. |
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| Raltegravir | Drug | Participants were administered Raltegravir orally as one 400 mg tablet twice daily (800 mg per day), with or without food |
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| Second line ART regimens - based on a boosted protease inhibitor (bPI) plus two nucleoside analogues (NRTIs) | Drug | LPV/r and ATV/r were the preferred bPIs for second-line ART. TDF + (3TC or FTC) or AZT + 3TC were the most frequent NRTI backbones. Cohort A did not include any of the new drugs; therefore, it is distinct from Cohorts B, C, and D. |
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| Study provided drugs according to patient resistance profile (DRV, ETR, RTV, FTC/TDF) + any in country available drug as applicable & available | Drug | For Cohort D, in many situations a participant received the same regimen that patients are getting in Cohorts B and C if that was the best combination that can be obtained according to his/her resistance profile and drug availability (as for many countries there were no further drug options beyond the available study drugs). |
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| SOC adherence versus SOC+CPI adherence | Other |
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| 24 weeks after the date of entry |
| Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 72 Weeks | The measurement closest to exactly 72 weeks (ie, 7x72=504 days) after the date of entry, within the window of 72 weeks ± 6 weeks (specifically 463 to 546 days, inclusive). The analysis in the protocol and in the Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 72 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 72 was considered as HIV-1 RNA>200 copies/mL at week 72. If a result was expected, missing results at week 72 were considered as HIV-1 RNA >200 copies/mL at week 72 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 72. Therefore, Wald confidence interval could not be computed for B3 and Clopper-Pearson Exact confidence interval is provided. | 72 weeks after the date of entry |
| Number of Weeks of Follow-up | All participants were followed on step 1/2 until 48 weeks after the last participant was enrolled to step 1 regardless of virologic status or treatment switches. Length of follow-up varied by Cohort. | 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 | Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. Length of follow-up varied by Cohort. | From week 24 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 | Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Length of follow-up varied by Cohort. | 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 by Week 48 | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry(to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. Length of follow-up varied by Cohort. | From week 24 to Week 48 |
| 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 | Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. Length of follow-up varied by Cohort. A new resistance-associated mutation is defined as one not present in the genotype prior to entry. | From week 24 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 | Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure[specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Length of follow-up varied by Cohort. A new resistance-associated mutation is defined as one not present in the genotype prior to entry. | 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 | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure[specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry(to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure.Event times were the scheduled week of the initial failing measurement(RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after).Censoring times were the scheduled week of the last RNA result.Length of follow-up varied by Cohort.A new resistance-associated mutation is defined as one not present in the genotype prior to entry. | From week 24 to Week 48 |
| Time From Study Entry/Randomization to Death | Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. | From study entry 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 | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. | From study entry to Week 48 |
| Time From Study Entry/Randomization to the First of Death, an AIDS-defining Event or a Non-AIDS-defining Event | Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events. Length of follow-up varied by Cohort. | From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks |
| Percent of Participants Experiencing Death, AIDS-defining Event or a Non-AIDS-defining Event by Week 48 | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events. | From study entry to Week 48 |
| Time From Study Entry/Randomization to the First of Death or Hospitalization. | Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis. Length of follow-up varied by Cohort. | 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 | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis. | From study entry to Week 48 |
| Time From Study Entry/Randomization to Treatment Modification or Discontinuation. | Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. | 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 | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. | From study entry to Week 48 |
| Time From Study Entry/Randomization to Treatment Modification or Discontinuation Due to Toxicity | Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. DAIDS AE Grading Table, Version 1.0 was used. | 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 Due to Toxicity by Week 48 | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. | From study entry to Week 48 |
| Time From Study Entry/Randomization to the Development of Immune Reconstitution Inflammatory Syndrome (IRIS) | Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. | From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks |
| Percent of Participants That Developed Immune Reconstitution Inflammatory Syndrome (IRIS) by Week 48 | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. | From study entry to week 48 |
| Time to First Dose Modification Due to Grade 3 or 4 Toxicity | Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. DAIDS AE Grading Table, Version 1.0 was used. | 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 | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. | From study entry to week 48 |
| Change From Baseline in CD4+ T-cell Count | Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) | Baseline, week 24, 48, and 72 |
| Change From Baseline in Fasting Values of Total Cholesterol | Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) | Baseline, week 24, 48 and 72 |
| Change From Baseline in Fasting Values of High-density Lipoprotein Cholesterol | Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A)] | Baseline, week 24, 48 and 72 |
| Change From Baseline in Fasting Values of Calculated Low-density Lipoprotein Cholesterol | Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) | Baseline, week 24, 48 and 72 |
| Change From Baseline in Fasting Values of Triglycerides | Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) | Baseline, week 24, 48 and 72 |
| Change From Baseline in Fasting Values of Glucose | Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) | Baseline, week 24, 48 and 72 |
| Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 48 Weeks [CPI+SOC v SOC] | 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. | 48 weeks after the date of entry |
| Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 24 Weeks [CPI+SOC v SOC] | The measurement closest to exactly 24 weeks (ie, 7x24=168 days) after the date of entry, within the window of 24 weeks ± 6 weeks (specifically 127 to 210 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 24 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 24 was considered as HIV-1 RNA>200 copies/mL at week 24. Missing results at week 24 were considered as HIV-1 RNA >200 copies/mL at week 24 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL. | 24 weeks after the date of entry |
| Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 72 Weeks [CPI+SOC v SOC] | The measurement closest to exactly 72 weeks (ie, 7x72=504 days) after the date of entry, within the window of 72 weeks ± 6 weeks (specifically 463 to 546 days, inclusive). The analysis in the protocol and in the Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 72 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 72 was considered as HIV-1 RNA>200 copies/mL at week 72. If a result was expected, missing results at week 72 were considered as HIV-1 RNA >200 copies/mL at week 72 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL. | 72 weeks after the date of entry |
| Number of Weeks of Follow-up [CPI+SOC v SOC] | All participants were followed on step 1/2 until 48 weeks after the last participant was enrolled to step 1 regardless of virologic status or treatment switches. | 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 [CPI+SOC v SOC] | Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. | From week 24 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 [CPI+SOC v SOC] | Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. | 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 by Week 48 [CPI+SOC v SOC] | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry(to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. | From week 24 to Week 48 |
| 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] | Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. A new resistance-associated mutation is defined as one not present in the genotype prior to entry. | From week 24 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] | Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure[specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. A new resistance-associated mutation is defined as one not present in the genotype prior to entry. | 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 [CPI+SOC v SOC] | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure[specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry(to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure.Event times were the scheduled week of the initial failing measurement(RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after).Censoring times were the scheduled week of the last RNA result.A new resistance-associated mutation is defined as one not present in the genotype prior to entry. | From week 24 to Week 48 |
| Time From Study Entry/Randomization to Death [CPI+SOC v SOC] | Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. | From study entry 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] | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. | From study entry to Week 48 |
| Time From Study Entry/Randomization to the First of Death, an AIDS-defining Event or a Non-AIDS-defining Event [CPI+SOC v SOC] | Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events. | From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks |
| Percent of Participants Experiencing Death, AIDS-defining Event or a Non-AIDS-defining Event by Week 48 [CPI+SOC v SOC] | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events. | From study entry to Week 48 |
| Time From Study Entry/Randomization to the First of Death or Hospitalization [CPI+SOC v SOC] | Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis. | 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 [CPI+SOC v SOC] | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis. | From study entry to Week 48 |
| Time From Study Entry/Randomization to Treatment Modification or Discontinuation [CPI+SOC v SOC] | Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. | 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] | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. | From study entry to Week 48 |
| Time From Study Entry/Randomization to Treatment Modification or Discontinuation Due to Toxicity [CPI+SOC v SOC] | Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. | 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 Due to Toxicity by Week 48 [CPI+SOC v SOC] | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. | From study entry to Week 48 |
| Time From Study Entry/Randomization to the Development of Immune Reconstitution Inflammatory Syndrome (IRIS) [CPI+SOC v SOC] | Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. | From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks |
| Percent of Participants That Developed Immune Reconstitution Inflammatory Syndrome (IRIS) by Week 48 [CPI+SOC v SOC] | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. | From study entry to Week 48 |
| Time to First Dose Modification Due to Grade 3 or 4 Toxicity [CPI+SOC v SOC] | Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. | 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] | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. | From study entry to Week 48 |
| Change From Baseline in CD4+ T-cell Count [CPI+SOC v SOC] | Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. | Baseline, week 24, 48, and 72 |
| Change From Baseline in Fasting Values of Total Cholesterol [CPI+SOC v SOC] | Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. | Baseline, week 24, 48, and 72 |
| Change From Baseline in Fasting Values of High-density Lipoprotein Cholesterol [CPI+SOC v SOC] | Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. | Baseline, week 24, 48, and 72 |
| Change From Baseline in Fasting Values of Calculated Low-density Lipoprotein Cholesterol [CPI+SOC v SOC] | Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. | Baseline, week 24, 48, and 72 |
| Change From Baseline in Fasting Values of Triglycerides [CPI+SOC v SOC] | Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. | Baseline, week 24, 48, and 72 |
| Change From Baseline in Fasting Values of Glucose [CPI+SOC v SOC] | Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. | Baseline, week 24, 48, and 72 |
| Rio de Janeiro |
| 21045 |
| Brazil |
| Les Centres GHESKIO CRS (30022) | Port-au-Prince | Bicentaire | HT-6110 | Haiti |
| GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS | Port-au-Prince | Haiti |
| BJ Medical College CRS (31441) | Pune | Maharashtra | 411001 | India |
| Chennai Antiviral Research and Treatment (CART) CRS (11701) | Chennai | Taramani | 600113 | India |
| AMPATH at Moi Univ. Teaching Hosp. Eldoret CRS (12601) | Eldoret | 30100 | Kenya |
| Kenya Medical Research Institute/Center for Disease Control (KEMRI/CDC) CRS (31460) | Kisumu | 40100 | Kenya |
| Malawi CRS (12001) | Lilongwe | Malawi |
| San Miguel CRS (11302) | San Miguel | Lima region | Peru |
| Barranco CRS (11301) | Lima | 18 PE | Peru |
| University of the Witwatersrand Helen Joseph (WITS HJH) CRS (11101) | Johannesburg | Gauteng | 2193 | South Africa |
| Family Clinical Research Unit (FAM-CUR) CRS (8950) | Cape Town | West Cape | 7505 | South Africa |
| Durban Adult HIV CRS (11201) | Durban | 4013 SF | South Africa |
| Soweto ACTG CRS (12301) | Johannesburg | South Africa |
| 31802 Thai Red Cross AIDS Research Centre (TRC-ARC) CRS | Bangkok | Patumwan | 10330 | Thailand |
| 31784 Chiang Mai University HIV Treatment CRS | Chiang Mai | 50200 | Thailand |
| JCRC CRS | Kampala | Uganda |
| UZ-Parirenyatwa CRS (30313) | Harare | Zimbabwe |
| Derived |
| Godfrey C, Hughes MD, Ritz J, Coelho L, Gross R, Salata R, Mngqibisa R, Wallis CL, Mumbi ME, Matoga M, Poongulali S, Van Schalkwyk M, Hogg E, Fletcher CV, Grinsztejn B, Collier AC; A5288 team. Brief Report: Sex Differences in Outcomes for Individuals Presenting for Third-Line Antiretroviral Therapy. J Acquir Immune Defic Syndr. 2020 Jun 1;84(2):203-207. doi: 10.1097/QAI.0000000000002324. |
| 31528850 | Derived | Gross R, Ritz J, Hughes MD, Salata R, Mugyenyi P, Hogg E, Wieclaw L, Godfrey C, Wallis CL, Mellors JW, Mudhune VO, Badal-Faesen S, Grinsztejn B, Collier AC. Two-way mobile phone intervention compared with standard-of-care adherence support after second-line antiretroviral therapy failure: a multinational, randomised controlled trial. Lancet Digit Health. 2019 May;1(1):e26-e34. doi: 10.1016/S2589-7500(19)30006-8. Epub 2019 May 6. |
| 31371262 | Derived | Grinsztejn B, Hughes MD, Ritz J, Salata R, Mugyenyi P, Hogg E, Wieclaw L, Gross R, Godfrey C, Cardoso SW, Bukuru A, Makanga M, Faesen S, Mave V, Wangari Ndege B, Nerette Fontain S, Samaneka W, Secours R, van Schalkwyk M, Mngqibisa R, Mohapi L, Valencia J, Sugandhavesa P, Montalban E, Avihingsanon A, Santos BR, Kumarasamy N, Kanyama C, Schooley RT, Mellors JW, Wallis CL, Collier AC; A5288 Team. Third-line antiretroviral therapy in low-income and middle-income countries (ACTG A5288): a prospective strategy study. Lancet HIV. 2019 Sep;6(9):e588-e600. doi: 10.1016/S2352-3018(19)30146-8. Epub 2019 Jul 29. |
| Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010 | View source |
| FG001 | Experimental: 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 |
| FG002 | Experimental: 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 |
| FG003 | Experimental: 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 |
| FG004 | Experimental: 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 |
| FG005 | Experimental: 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 |
| FG006 | Cell Phone Intervention (CPI) + Standard of Care (SOC) | The CPI was a simple interactive system (Short Message Service [SMS] Reminder and Flashback System) to identify non-adherence soon after it occurred and, in response, a site-based culturally relevant algorithm for managing barriers to adherence. Reminders were sent daily for the first 8 weeks on study, then three times per week for the next 8 weeks, and then weekly through to 48 weeks after study entry. Participants were expected to respond ("flashback") to each reminder. Failure to respond, triggered the system to alert the site to contact the participant. Sites were instructed to contact the participant if they missed any three flashbacks over two weeks during the daily messaging period, any two missed flashbacks over two weeks of the three times a week messaging period, and any two missed flashbacks over two weeks during the weekly messaging period. Additionally, sites were instructed to continue the local standard of care practices for managing adherence barriers. |
| FG007 | Standard of Care (SOC) | Sites were instructed to continue the local standard of care practices for managing adherence barriers. |
|
| Followed 72 Weeks on Step 1/2 |
|
| COMPLETED | Completed the study = participant must have had the last step 1/2 visit between 22NOV2016-13FEB2017 |
|
| NOT COMPLETED |
|
|
| Randomized Adherence Intervention |
|
|
All enrolled participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: 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. |
| BG001 | Experimental: 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 |
| BG002 | Experimental: 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 |
| BG003 | Experimental: 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 |
| BG004 | Experimental: 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 |
| BG005 | Experimental: 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 |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Plasma HIV-1 RNA, categorical | Baseline Plasma HIV-1 RNA is defined as the last available result on or before the date of study entry | Count of Participants | Participants |
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| CD4+ T-Cell Count, categorical | Baseline CD4+ T-cell count is defined as the last available result on or before the date of study entry | Count of Participants | Participants |
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| IV drug history, categorical | Count of Participants | Participants |
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| Hepatitis B Surface Antigen Result, categorical | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||
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| Primary | Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 48 Weeks | 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. | All enrolled participants | Posted | Number | 95% Confidence Interval | proportion of participants | 48 weeks after the date of entry |
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| Secondary | Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 24 Weeks | The measurement closest to exactly 24 weeks (ie, 7x24=168 days) after the date of entry, within the window of 24 weeks ± 6 weeks (specifically 127 to 210 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 24 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 24 was considered as HIV-1 RNA>200 copies/mL at week 24. Missing results at week 24 were considered as HIV-1 RNA >200 copies/mL at week 24 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 24. Therefore, Wald confidence interval could not be computed for B3 and Clopper-Pearson Exact confidence interval is provided. | All enrolled participants | Posted | Number | 95% Confidence Interval | proportion of participants | 24 weeks after the date of entry |
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| Secondary | Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 72 Weeks | The measurement closest to exactly 72 weeks (ie, 7x72=504 days) after the date of entry, within the window of 72 weeks ± 6 weeks (specifically 463 to 546 days, inclusive). The analysis in the protocol and in the Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 72 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 72 was considered as HIV-1 RNA>200 copies/mL at week 72. If a result was expected, missing results at week 72 were considered as HIV-1 RNA >200 copies/mL at week 72 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 72. Therefore, Wald confidence interval could not be computed for B3 and Clopper-Pearson Exact confidence interval is provided. | All participants with results expected at week 72 | Posted | Number | 95% Confidence Interval | proportion of participants | 72 weeks after the date of entry |
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| Secondary | Number of Weeks of Follow-up | All participants were followed on step 1/2 until 48 weeks after the last participant was enrolled to step 1 regardless of virologic status or treatment switches. Length of follow-up varied by Cohort. | all enrolled participants | Posted | Median | Inter-Quartile Range | weeks | From study entry through Step 1/2 follow-up |
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| Secondary | Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study | Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. Length of follow-up varied by Cohort. | All enrolled participants | Posted | Number | 95% Confidence Interval | weeks | From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks |
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| Secondary | Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study | Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Length of follow-up varied by Cohort. | All enrolled participants | Posted | Count of Participants | Participants | From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks |
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| Secondary | Percent of Participants With Confirmed Virologic Failure by Week 48 | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry(to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. Length of follow-up varied by Cohort. | All enrolled participants | Posted | Number | 95% Confidence Interval | percentage of participants | From week 24 to Week 48 |
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| Secondary | 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 | Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. Length of follow-up varied by Cohort. A new resistance-associated mutation is defined as one not present in the genotype prior to entry. | All enrolled participants | Posted | Number | 95% Confidence Interval | weeks | From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks |
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| Secondary | 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 | Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure[specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Length of follow-up varied by Cohort. A new resistance-associated mutation is defined as one not present in the genotype prior to entry. | All enrolled participants | Posted | Count of Participants | Participants | From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks |
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| Secondary | 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 | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure[specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry(to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure.Event times were the scheduled week of the initial failing measurement(RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after).Censoring times were the scheduled week of the last RNA result.Length of follow-up varied by Cohort.A new resistance-associated mutation is defined as one not present in the genotype prior to entry. | All enrolled participants | Posted | Number | 95% Confidence Interval | percentage of participants | From week 24 to Week 48 |
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| Secondary | Time From Study Entry/Randomization to Death | Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. | all enrolled participants | Posted | Number | 95% Confidence Interval | weeks | From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks |
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| Secondary | Percent of Participants Experiencing Death by Week 48 | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. | all enrolled participants | Posted | Number | 95% Confidence Interval | percentage of participants | From study entry to Week 48 |
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| Secondary | Time From Study Entry/Randomization to the First of Death, an AIDS-defining Event or a Non-AIDS-defining Event | Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events. Length of follow-up varied by Cohort. | all enrolled participants | Posted | Number | 95% Confidence Interval | weeks | From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks |
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| Secondary | Percent of Participants Experiencing Death, AIDS-defining Event or a Non-AIDS-defining Event by Week 48 | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events. | all enrolled participants | Posted | Number | 95% Confidence Interval | percentage of participants | From study entry to Week 48 |
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| Secondary | Time From Study Entry/Randomization to the First of Death or Hospitalization. | Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis. Length of follow-up varied by Cohort. | all enrolled participants | Posted | Number | 95% Confidence Interval | weeks | From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks |
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| Secondary | Percent of Participants With Death or Hospitalization by Week 48 | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis. | all enrolled participants | Posted | Number | 95% Confidence Interval | percentage of participants | From study entry to Week 48 |
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| Secondary | Time From Study Entry/Randomization to Treatment Modification or Discontinuation. | Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. | all enrolled participants | Posted | Number | 95% Confidence Interval | weeks | From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks |
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| Secondary | Percent of Participants With Treatment Modification or Discontinuation by Week 48 | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. | all enrolled participants | Posted | Number | 95% Confidence Interval | percentage of participants | From study entry to Week 48 |
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| Secondary | Time From Study Entry/Randomization to Treatment Modification or Discontinuation Due to Toxicity | Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. DAIDS AE Grading Table, Version 1.0 was used. | all enrolled participants | Posted | Number | 95% Confidence Interval | weeks | From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks |
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| Secondary | Percent of Participants With Treatment Modification or Discontinuation Due to Toxicity by Week 48 | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. | all enrolled participants | Posted | Number | 95% Confidence Interval | percentage of participants | From study entry to Week 48 |
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| Secondary | Time From Study Entry/Randomization to the Development of Immune Reconstitution Inflammatory Syndrome (IRIS) | Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. | all enrolled participants | Posted | Number | 95% Confidence Interval | weeks | From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks |
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| Secondary | Percent of Participants That Developed Immune Reconstitution Inflammatory Syndrome (IRIS) by Week 48 | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. | all enrolled participants | Posted | Number | 95% Confidence Interval | percentage of participants | From study entry to week 48 |
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| Secondary | Time to First Dose Modification Due to Grade 3 or 4 Toxicity | Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. DAIDS AE Grading Table, Version 1.0 was used. | all enrolled participants | Posted | Number | 95% Confidence Interval | weeks | From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks |
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| Secondary | Percent of Participants With a Dose Modification Due to Grade 3 or 4 Toxicity by Week 48 | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. | all enrolled participants | Posted | Number | 95% Confidence Interval | percentage of participants | From study entry to week 48 |
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| Secondary | Change From Baseline in CD4+ T-cell Count | Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) | all enrolled participants with results available at baseline and at the given follow-up time point | Posted | Mean | Standard Deviation | cells/mm^3 | Baseline, week 24, 48, and 72 |
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| Secondary | Change From Baseline in Fasting Values of Total Cholesterol | Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) | all enrolled participants with results available at baseline and at the given follow-up time point | Posted | Mean | Standard Deviation | mg/dL | Baseline, week 24, 48 and 72 |
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| Secondary | Change From Baseline in Fasting Values of High-density Lipoprotein Cholesterol | Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A)] | all enrolled participants with results available at baseline and at the given follow-up time point | Posted | Mean | Standard Deviation | mg/dL | Baseline, week 24, 48 and 72 |
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| Secondary | Change From Baseline in Fasting Values of Calculated Low-density Lipoprotein Cholesterol | Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) | all enrolled participants with results available at baseline and at the given follow-up time point | Posted | Mean | Standard Deviation | mg/dL | Baseline, week 24, 48 and 72 |
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| Secondary | Change From Baseline in Fasting Values of Triglycerides | Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) | all enrolled participants with results available at baseline and at the given follow-up time point | Posted | Mean | Standard Deviation | mg/dL | Baseline, week 24, 48 and 72 |
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| Secondary | Change From Baseline in Fasting Values of Glucose | Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) | all enrolled participants with results available at baseline and at the given follow-up time point | Posted | Mean | Standard Deviation | mg/dL | Baseline, week 24, 48 and 72 |
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| Secondary | Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 48 Weeks [CPI+SOC v SOC] | 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. | All participants randomized to either CPI+SOC or SOC | Posted | Number | 95% Confidence Interval | proportion of participants | 48 weeks after the date of entry |
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| Secondary | Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 24 Weeks [CPI+SOC v SOC] | The measurement closest to exactly 24 weeks (ie, 7x24=168 days) after the date of entry, within the window of 24 weeks ± 6 weeks (specifically 127 to 210 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 24 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 24 was considered as HIV-1 RNA>200 copies/mL at week 24. Missing results at week 24 were considered as HIV-1 RNA >200 copies/mL at week 24 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL. | All participants randomized to either CPI+SOC or SOC | Posted | Number | 95% Confidence Interval | proportion of participants | 24 weeks after the date of entry |
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| Secondary | Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 72 Weeks [CPI+SOC v SOC] | The measurement closest to exactly 72 weeks (ie, 7x72=504 days) after the date of entry, within the window of 72 weeks ± 6 weeks (specifically 463 to 546 days, inclusive). The analysis in the protocol and in the Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 72 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 72 was considered as HIV-1 RNA>200 copies/mL at week 72. If a result was expected, missing results at week 72 were considered as HIV-1 RNA >200 copies/mL at week 72 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL. | All participants randomized to either CPI+SOC or SOC with results expected at week 72 | Posted | Number | 95% Confidence Interval | proportion of participants | 72 weeks after the date of entry |
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| Secondary | Number of Weeks of Follow-up [CPI+SOC v SOC] | All participants were followed on step 1/2 until 48 weeks after the last participant was enrolled to step 1 regardless of virologic status or treatment switches. | All participants randomized to either CPI+SOC or SOC | Posted | Median | Inter-Quartile Range | weeks | From study entry through Step 1/2 follow-up |
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| Secondary | 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] | Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. | All participants randomized to either CPI+SOC or SOC | Posted | Number | 95% Confidence Interval | weeks | From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks |
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| Secondary | 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] | Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. | All participants randomized to either CPI+SOC or SOC | Posted | Count of Participants | Participants | From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks |
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| Secondary | Percent of Participants With Confirmed Virologic Failure by Week 48 [CPI+SOC v SOC] | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry(to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. | All participants randomized to either CPI+SOC or SOC | Posted | Number | 95% Confidence Interval | percentage of participants | From week 24 to Week 48 |
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| Secondary | 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] | Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. A new resistance-associated mutation is defined as one not present in the genotype prior to entry. | All participants randomized to either CPI+SOC or SOC | Posted | Number | 95% Confidence Interval | weeks | From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks |
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| Secondary | 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] | Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure[specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. A new resistance-associated mutation is defined as one not present in the genotype prior to entry. | All participants randomized to either CPI+SOC or SOC | Posted | Count of Participants | Participants | From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks |
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| Secondary | 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] | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure[specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry(to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure.Event times were the scheduled week of the initial failing measurement(RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after).Censoring times were the scheduled week of the last RNA result.A new resistance-associated mutation is defined as one not present in the genotype prior to entry. | All participants randomized to either CPI+SOC or SOC | Posted | Number | 95% Confidence Interval | percentage of participants | From week 24 to Week 48 |
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| Secondary | Time From Study Entry/Randomization to Death [CPI+SOC v SOC] | Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. | All participants randomized to either CPI+SOC or SOC | Posted | Number | 95% Confidence Interval | weeks | From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks |
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| Secondary | Percent of Participants Experiencing Death by Week 48 [CPI+SOC v SOC] | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. | All participants randomized to either CPI+SOC or SOC | Posted | Number | 95% Confidence Interval | percentage of participants | From study entry to Week 48 |
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| Secondary | Time From Study Entry/Randomization to the First of Death, an AIDS-defining Event or a Non-AIDS-defining Event [CPI+SOC v SOC] | Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events. | All participants randomized to either CPI+SOC or SOC | Posted | Number | 95% Confidence Interval | weeks | From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks |
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| Secondary | Percent of Participants Experiencing Death, AIDS-defining Event or a Non-AIDS-defining Event by Week 48 [CPI+SOC v SOC] | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events. | All participants randomized to either CPI+SOC or SOC | Posted | Number | 95% Confidence Interval | percentage of participants | From study entry to Week 48 |
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| Secondary | Time From Study Entry/Randomization to the First of Death or Hospitalization [CPI+SOC v SOC] | Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis. | All participants randomized to either CPI+SOC or SOC | Posted | Number | 95% Confidence Interval | weeks | From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks |
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| Secondary | Percent of Participants With Death or Hospitalization by Week 48 [CPI+SOC v SOC] | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis. | All participants randomized to either CPI+SOC or SOC | Posted | Number | 95% Confidence Interval | percentage of participants | From study entry to Week 48 |
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| Secondary | Time From Study Entry/Randomization to Treatment Modification or Discontinuation [CPI+SOC v SOC] | Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. | All participants randomized to either CPI+SOC or SOC | Posted | Number | 95% Confidence Interval | weeks | From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks |
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| Secondary | Percent of Participants With Treatment Modification or Discontinuation by Week 48 [CPI+SOC v SOC] | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. | All participants randomized to either CPI+SOC or SOC | Posted | Number | 95% Confidence Interval | percentage of participants | From study entry to Week 48 |
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| Secondary | Time From Study Entry/Randomization to Treatment Modification or Discontinuation Due to Toxicity [CPI+SOC v SOC] | Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. | All participants randomized to either CPI+SOC or SOC | Posted | Number | 95% Confidence Interval | weeks | From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks |
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| Secondary | Percent of Participants With Treatment Modification or Discontinuation Due to Toxicity by Week 48 [CPI+SOC v SOC] | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. | All participants randomized to either CPI+SOC or SOC | Posted | Number | 95% Confidence Interval | percentage of participants | From study entry to Week 48 |
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| Secondary | Time From Study Entry/Randomization to the Development of Immune Reconstitution Inflammatory Syndrome (IRIS) [CPI+SOC v SOC] | Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. | All participants randomized to either CPI+SOC or SOC | Posted | Number | 95% Confidence Interval | weeks | From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks |
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| Secondary | Percent of Participants That Developed Immune Reconstitution Inflammatory Syndrome (IRIS) by Week 48 [CPI+SOC v SOC] | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. | All participants randomized to either CPI+SOC or SOC | Posted | Number | 95% Confidence Interval | percentage of participants | From study entry to Week 48 |
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| Secondary | Time to First Dose Modification Due to Grade 3 or 4 Toxicity [CPI+SOC v SOC] | Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. | All participants randomized to either CPI+SOC or SOC | Posted | Number | 95% Confidence Interval | weeks | From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks |
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| Secondary | Percent of Participants With a Dose Modification Due to Grade 3 or 4 Toxicity by Week 48 [CPI+SOC v SOC] | Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. | All participants randomized to either CPI+SOC or SOC | Posted | Number | 95% Confidence Interval | percentage of participants | From study entry to Week 48 |
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| Secondary | Change From Baseline in CD4+ T-cell Count [CPI+SOC v SOC] | Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. | All participants randomized to either CPI+SOC or SOC with results available at baseline and at the given follow-up time point | Posted | Mean | Standard Deviation | cells/mm^3 | Baseline, week 24, 48, and 72 |
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| Secondary | Change From Baseline in Fasting Values of Total Cholesterol [CPI+SOC v SOC] | Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. | All participants randomized to either CPI+SOC or SOC with results available at baseline and at the given follow-up time point | Posted | Mean | Standard Deviation | mg/dL | Baseline, week 24, 48, and 72 |
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| Secondary | Change From Baseline in Fasting Values of High-density Lipoprotein Cholesterol [CPI+SOC v SOC] | Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. | All participants randomized to either CPI+SOC or SOC with results available at baseline and at the given follow-up time point | Posted | Mean | Standard Deviation | mg/dL | Baseline, week 24, 48, and 72 |
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| Secondary | Change From Baseline in Fasting Values of Calculated Low-density Lipoprotein Cholesterol [CPI+SOC v SOC] | Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. | All participants randomized to either CPI+SOC or SOC with results available at baseline and at the given follow-up time point | Posted | Mean | Standard Deviation | mg/dL | Baseline, week 24, 48, and 72 |
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| Secondary | Change From Baseline in Fasting Values of Triglycerides [CPI+SOC v SOC] | Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. | All participants randomized to either CPI+SOC or SOC with results available at baseline and at the given follow-up time point | Posted | Mean | Standard Deviation | mg/dL | Baseline, week 24, 48, and 72 |
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| Secondary | Change From Baseline in Fasting Values of Glucose [CPI+SOC v SOC] | Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. | All participants randomized to either CPI+SOC or SOC with results available at baseline and at the given follow-up time point | Posted | Mean | Standard Deviation | mg/dL | Baseline, week 24, 48, and 72 |
|
From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred <30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental: 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. | 18 | 287 | 61 | 287 | 283 | 287 |
| EG001 | Experimental: 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 | 1 | 74 | 8 | 74 | 72 | 74 |
| EG002 | Experimental: 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 | 2 | 72 | 13 | 72 | 69 | 72 |
| EG003 | Experimental: 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 | 0 | 8 | 1 | 8 | 8 | 8 |
| EG004 | Experimental: 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 | 1 | 70 | 9 | 70 | 69 | 70 |
| EG005 | Experimental: 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 | 1 | 34 | 6 | 34 | 33 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Anaemia megaloblastic | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Ulcerative keratitis | Eye disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Immunosuppression | Immune system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Amoebiasis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Cerebral toxoplasmosis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Disseminated tuberculosis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| HIV-associated neurocognitive disorder | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Leptospirosis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Mastoiditis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Meningitis bacterial | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Meningitis cryptococcal | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Meningitis pneumococcal | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Neurocryptococcosis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonia haemophilus | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Scrub typhus | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Traumatic fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dystonia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abortion | Pregnancy, puerperium and perinatal conditions | MedDRA 20.1 | Systematic Assessment |
| |
| Abortion threatened | Pregnancy, puerperium and perinatal conditions | MedDRA 20.1 | Systematic Assessment |
| |
| Foetal hypokinesia | Pregnancy, puerperium and perinatal conditions | MedDRA 20.1 | Systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 20.1 | Systematic Assessment |
| |
| Stillbirth | Pregnancy, puerperium and perinatal conditions | MedDRA 20.1 | Systematic Assessment |
| |
| Glomerulonephritis | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Idiopathic interstitial pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pelvic venous thrombosis | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis allergic | Eye disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Peptic ulcer | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Acarodermatitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Bacterial vaginosis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Chronic hepatitis B | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Conjunctivitis bacterial | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Helminthic infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Purulent discharge | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase abnormal | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood bicarbonate decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood glucose decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood sodium increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Low density lipoprotein increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Urine odour abnormal | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oropharyngeal plaque | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Sinus pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| ACTG Clinicaltrials.gov Coordinator | ACTG Network Coordinating Center, Social and Scientific Systems, Inc. | (301) 628-3313 | ACTGCT.Gov@s-3.com |
| ID | Term |
|---|---|
| D000069454 | Darunavir |
| C451734 | etravirine |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| D000068898 | Raltegravir Potassium |
| C021623 | bactericidal permeability increasing protein |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D005663 | Furans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D000068679 | Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D013844 | Thiazoles |
| D001393 | Azoles |
Not provided
Not provided
| Lost to Follow-up |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Haiti |
|
| India |
|
| Kenya |
|
| Malawi |
|
| Peru |
|
| South Africa |
|
| Thailand |
|
| Uganda |
|
| Zimbabwe |
|
| 40 - < 200 copies/mL |
|
| 200 - < 1000 copies/mL |
|
| 1000 - < 10,000 copies/mL |
|
| 10,000 - < 100,000 copies/mL |
|
| 100,000 - < 1,000,000 copies/mL |
|
| 1,000,000 - < 10,000,000 copies/mL |
|
| >= 10,000,000 copies/mL |
|
| 50 - < 200 cells/mm^3 |
|
| 200 - < 350 cells/mm^3 |
|
| 350 - < 500 cells/mm^3 |
|
| >= 500 cells/mm^3 |
|
| Previously |
|
| Negative |
|
| Indeterminate |
|
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 |
| OG005 | Experimental: 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 |
| OG006 | Experimental: 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 |
| OG002 | Experimental: 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 |
| OG003 | Experimental: 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 |
| OG004 | Experimental: 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 |
| OG005 | Experimental: 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 |
| OG006 | Experimental: 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 |
|
|
| OG002 | Experimental: 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 |
| OG003 | Experimental: 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 |
| OG004 | Experimental: 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 |
| OG005 | Experimental: 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 |
| OG006 | Experimental: 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 |
|
|
| OG002 | Experimental: 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 |
| OG003 | Experimental: 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 |
| OG004 | Experimental: 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 |
| OG005 | Experimental: 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 |
|
|
| OG001 | Experimental: 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 |
| OG002 | Experimental: 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 |
| OG003 | Experimental: 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 |
| OG004 | Experimental: 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 |
| OG005 | Experimental: 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 |
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| Experimental: 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 |
| OG002 | Experimental: 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 |
| OG003 | Experimental: 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 |
| OG004 | Experimental: 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 |
| OG005 | Experimental: 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 |
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| OG001 | Experimental: 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 |
| OG002 | Experimental: 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 |
| OG003 | Experimental: 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 |
| OG004 | Experimental: 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 |
| OG005 | Experimental: 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 |
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| OG001 | Experimental: 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 |
| OG002 | Experimental: 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 |
| OG003 | Experimental: 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 |
| OG004 | Experimental: 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 |
| OG005 | Experimental: 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 |
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| OG001 | Experimental: 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 |
| OG002 | Experimental: 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 |
| OG003 | Experimental: 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 |
| OG004 | Experimental: 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 |
| OG005 | Experimental: 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 |
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| OG001 | Experimental: 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 |
| OG002 | Experimental: 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 |
| OG003 | Experimental: 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 |
| OG004 | Experimental: 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 |
| OG005 | Experimental: 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 |
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| OG002 | Experimental: 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 |
| OG003 | Experimental: 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 |
| OG004 | Experimental: 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 |
| OG005 | Experimental: 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 |
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| OG002 | Experimental: 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 |
| OG003 | Experimental: 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 |
| OG004 | Experimental: 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 |
| OG005 | Experimental: 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 |
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| Experimental: 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 |
| OG002 | Experimental: 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 |
| OG003 | Experimental: 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 |
| OG004 | Experimental: 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 |
| OG005 | Experimental: 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 |
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| Experimental: 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 |
| OG002 | Experimental: 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 |
| OG003 | Experimental: 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 |
| OG004 | Experimental: 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 |
| OG005 | Experimental: 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 |
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| OG002 | Experimental: 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 |
| OG003 | Experimental: 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 |
| OG004 | Experimental: 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 |
| OG005 | Experimental: 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 |
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| OG002 | Experimental: 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 |
| OG003 | Experimental: 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 |
| OG004 | Experimental: 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 |
| OG005 | Experimental: 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 |
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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
| OG002 | Experimental: 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 |
| OG003 | Experimental: 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 |
| OG004 | Experimental: 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 |
| OG005 | Experimental: 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 |
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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 |
| OG002 | Experimental: 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 |
| OG003 | Experimental: 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 |
| OG004 | Experimental: 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 |
| OG005 | Experimental: 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 |
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| Experimental: 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 |
| OG002 | Experimental: 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 |
| OG003 | Experimental: 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 |
| OG004 | Experimental: 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 |
| OG005 | Experimental: 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 |
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| Experimental: 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 |
| OG002 | Experimental: 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 |
| OG003 | Experimental: 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 |
| OG004 | Experimental: 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 |
| OG005 | Experimental: 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 |
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| OG002 | Experimental: 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 |
| OG003 | Experimental: 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 |
| OG004 | Experimental: 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 |
| OG005 | Experimental: 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 |
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| OG002 | Experimental: 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 |
| OG003 | Experimental: 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 |
| OG004 | Experimental: 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 |
| OG005 | Experimental: 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 |
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| OG002 | Experimental: 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 |
| OG003 | Experimental: 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 |
| OG004 | Experimental: 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 |
| OG005 | Experimental: 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 |
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| OG002 | Experimental: 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 |
| OG003 | Experimental: 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 |
| OG004 | Experimental: 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 |
| OG005 | Experimental: 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 |
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| OG002 | Experimental: 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 |
| OG003 | Experimental: 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 |
| OG004 | Experimental: 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 |
| OG005 | Experimental: 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 |
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| OG002 | Experimental: 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 |
| OG003 | Experimental: 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 |
| OG004 | Experimental: 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 |
| OG005 | Experimental: 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 |
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| OG002 | Experimental: 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 |
| OG003 | Experimental: 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 |
| OG004 | Experimental: 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 |
| OG005 | Experimental: 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 |
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| OG002 | Experimental: 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 |
| OG003 | Experimental: 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 |
| OG004 | Experimental: 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 |
| OG005 | Experimental: 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 |
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| OG002 | Experimental: 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 |
| OG003 | Experimental: 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 |
| OG004 | Experimental: 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 |
| OG005 | Experimental: 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 |
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| OG002 | Experimental: 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 |
| OG003 | Experimental: 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 |
| OG004 | Experimental: 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 |
| OG005 | Experimental: 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 |
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| OG001 | Standard of Care (SOC) | Sites were instructed to continue the local standard of care practices for managing adherence barriers. |
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| OG001 | Standard of Care (SOC) | Sites were instructed to continue the local standard of care practices for managing adherence barriers. |
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| OG001 | Standard of Care (SOC) | Sites were instructed to continue the local standard of care practices for managing adherence barriers. |
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| OG001 | Standard of Care (SOC) | Sites were instructed to continue the local standard of care practices for managing adherence barriers. |
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| OG001 | Standard of Care (SOC) | Sites were instructed to continue the local standard of care practices for managing adherence barriers. |
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| OG001 | Standard of Care (SOC) | Sites were instructed to continue the local standard of care practices for managing adherence barriers. |
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| OG001 | Standard of Care (SOC) | Sites were instructed to continue the local standard of care practices for managing adherence barriers. |
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| OG001 | Standard of Care (SOC) | Sites were instructed to continue the local standard of care practices for managing adherence barriers. |
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| OG001 | Standard of Care (SOC) | Sites were instructed to continue the local standard of care practices for managing adherence barriers. |
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Sites were instructed to continue the local standard of care practices for managing adherence barriers.
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Sites were instructed to continue the local standard of care practices for managing adherence barriers. |
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| OG001 | Standard of Care (SOC) | Sites were instructed to continue the local standard of care practices for managing adherence barriers. |
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| OG001 | Standard of Care (SOC) | Sites were instructed to continue the local standard of care practices for managing adherence barriers. |
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| OG001 |
| Standard of Care (SOC) |
Sites were instructed to continue the local standard of care practices for managing adherence barriers. |
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| OG001 | Standard of Care (SOC) | Sites were instructed to continue the local standard of care practices for managing adherence barriers. |
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| OG001 | Standard of Care (SOC) | Sites were instructed to continue the local standard of care practices for managing adherence barriers. |
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| OG001 | Standard of Care (SOC) | Sites were instructed to continue the local standard of care practices for managing adherence barriers. |
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| OG001 | Standard of Care (SOC) | Sites were instructed to continue the local standard of care practices for managing adherence barriers. |
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| OG001 | Standard of Care (SOC) | Sites were instructed to continue the local standard of care practices for managing adherence barriers. |
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Sites were instructed to continue the local standard of care practices for managing adherence barriers. |
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| Standard of Care (SOC) |
Sites were instructed to continue the local standard of care practices for managing adherence barriers. |
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Sites were instructed to continue the local standard of care practices for managing adherence barriers. |
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| OG001 |
| Standard of Care (SOC) |
Sites were instructed to continue the local standard of care practices for managing adherence barriers. |
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| OG001 |
| Standard of Care (SOC) |
Sites were instructed to continue the local standard of care practices for managing adherence barriers. |
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| OG001 |
| Standard of Care (SOC) |
Sites were instructed to continue the local standard of care practices for managing adherence barriers. |
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| OG001 |
| Standard of Care (SOC) |
Sites were instructed to continue the local standard of care practices for managing adherence barriers. |
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| OG001 | Standard of Care (SOC) | Sites were instructed to continue the local standard of care practices for managing adherence barriers. |
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| OG001 |
| Standard of Care (SOC) |
Sites were instructed to continue the local standard of care practices for managing adherence barriers. |
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| OG001 |
| Standard of Care (SOC) |
Sites were instructed to continue the local standard of care practices for managing adherence barriers. |
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