HIV Infection, Infection, Human Immunodeficiency Virus I
Conditions
Keywords
NORVIR, ARIES, EPZICOM, REYATAZ, HIV, simplification, Antiretroviral-naive
Brief summary
This study was designed to test the efficacy, safety, tolerability and durability of the antiviral response between atazanavir (ATV) + ritonavir (/r) + abacavir/lamivudine(ABC/3TC) Fixed dose combination (FDC) each administered once daily (QD) for 36 weeks followed by randomization to either a simplification regimen of ATV or continuation of ATV +/r for an additional 48 weeks, each in combination with ABC/3TC in antiretroviral (ART)-naive, HIV-1 infected, HLA-B\*5701 negative subjects. All subjects who complete the 84-week study will be eligible to enter the treatment extension phase and continue for an additional 60 weeks. The purpose of this extension is to obtain longer term treatment data in subjects who have completed the 84-week study.
Detailed description
Safety and Efficacy of an Initial Regimen of Atazanavir (ATV) + Ritonavir (/r) + the Abacavir/Lamivudine Fixed-Dose Combination Tablet (ABC/3TC FDC) for 36 weeks followed by Simplification to Atazanavir with ABC/3TC FDC or Maintenance of the Initial Regimen for an Additional 48 weeks in Antiretroviral-Naive HIV-1 Infected HLA-B\*5701 Negative Subjects followed by an Optional 60-Week Treatment Extension Phase
Interventions
DRUGAbacavir (ABC)/lamivudine (3TC) + atazanavir (ATV) + ritonavir (/r)
Abacavir (ABC)/lamivudine (3TC) FDC + atazanavir (ATV)+ ritoanvir (/r) for 36weeks followed by ABC/3TC + ATV + /r for 48wks followed by optional treatment extension for 60 weeks on the same regimen
DRUGAbacavir (ABC)/lamivudine (3TC) + atazanavir (ATV)
Abacavir (ABC)/lamivudine (3TC) FDC + atazanavir (ATV) + ritonavir (/r) for 36 weeks followed by ABC/3TC + ATV for 48wks followed by optional treatment extension for 60 weeks on the same regimen
Sponsors
GlaxoSmithKline
ViiV Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is ≥ 18 years of age and has documented evidence of HIV-1 infection. (A female is eligible to enter and participate in this study if she is of: non child-bearing potential, child bearing potential with a negative pregnancy test and agrees to approved contraception methods, or agreement for complete abstinence.) * Subject is antiretroviral-naïve (defined as having ≤14 days of prior therapy with any NRTI and no prior therapy with either a PI or NNRTI). * Subject has plasma HIV-1 RNA ≥ 1,000 copies/mL by Roche COBAS AMPLICOR™ (Version 1.5) method at screening (if no other documentation of HIV infection is available, a positive result here may serve as documentation of HIV infection for this study). * Subject is willing and able to understand and provide written informed consent prior to participation in this study.
Exclusion criteria
* Subject is HLA-B\*5701 positive. * Subject testing positive for Hepatitis B or both Hepatitis B and Hepatitis C at screening (+ HbsAg) * Genotyping results performed at the screening indicate that the subject has any of the following mutations at the reverse transcriptase (RT) enzyme: K65R, L74V, or Y115F, or a combination of two or more thymidine analog mutations (M41L, D67N, K70R, K219Q or E) that include changes at either L210 or T215, or ≥ 3 of the following protease mutations associated with atazanavir resistance: D30, V32, M36, M46, I47, G48, I50, I54, A71, G73, V77, V82, I84, N88, and L90. * Women who are pregnant or breastfeeding. * Subject has an active or acute CDC Clinical Category C event at screening. Treatment for the acute event must have been completed at least 30 days prior to screening. * Subject is, in the opinion of the investigator, unable to complete the 84-week dosing period and protocol evaluations and assessments. * Subject has ongoing clinically relevant pancreatitis or clinically relevant hepatitis at screening. * Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment. * Subject suffers from a serious medical condition, such as diabetes, congestive heart failure, cardiomyopathy or other cardiac dysfunction (including known, clinically significant cardiac conduction system disease, severe first degree atrioventricular block \[PR interval \> 0.26 seconds\], second or third-degree atrioventricular block), which in the opinion of the investigator would compromise the safety of the subject. * Subject has pre-existing mental, physical, or substance abuse disorder, which in the opinion of the investigator would interfere with the subject's ability to comply with the dosing schedule and protocol evaluations and assessments. * Subject has a history of inflammatory bowel disease or malignancy, intestinal ischemia, malabsorption, or other gastrointestinal dysfunction, which may interfere with drug absorption or render the subject unable to take oral medication. * Subject requires treatment with foscarnet, hydroxyurea or other agents with documented activity against HIV-1 in vitro within 28 days of study administration. * Subject requires treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, vaccines, or interferons) within 28 days prior to screening, or subject had received an HIV-1 immunotherapeutic vaccine within 90 days prior to screening. Subjects using inhaled corticosteroids are eligible for enrollment. * Creatinine clearance \<50 mL/min via the Cockroft-Gault method \[Cockroft, 1976\]. * Active alcohol or substance use sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis. * Hypersensitivity to any component of the study drugs. * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>5 times the upper limit of normal (ULN). * Total bilirubin \> 1.5 times the upper limit of normal (ULN). * Subject has any acute laboratory abnormality at screening, which, in the opinion of the investigator, would preclude the subject's participation in the study of an investigational compound. Any grade 4 laboratory abnormality would exclude a subject from study participation. * Subject requires treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days prior to screening, or has an anticipated need for these agents within the study period. * Enrolled in one or more investigational drug protocols, which may have impacted HIV-1 RNA suppression. * Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study. * Subjects requiring concomitant administration of proton pump inhibitors. * Subjects who require treatment with the prohibited medications within 28 days of commencement of investigational product, or an anticipated need during the study. Eligibility Criteria for Treatment Extension Phase: -Subjects will be eligible to continue in the treatment extension phase (Weeks 84 to 144) if they have successfully completed the 84-week study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c) /Milliliter (ml) at the Week 84 Visit | Week 84 | The percentage of PAR with HIV-1 RNA virus \<50 c/ml determined from a blood sample drawn at Week 84 was tabulated by treatment arm with stratification by baseline HIV-1 RNA (\<100,000 c/ml and \>=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed viral load \<50 c/ml who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA \<50 c/ml, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 50 c/ml, or had an unconfirmed HIV RNA of at least 50 c/ml at last visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 36 Visit | Week 36 | The percentage of PAR with HIV-1 RNA virus \<50 c/ml from a Week 36 blood sample was tabulated. Per TLOVR algorithm, responders were PAR with confirmed viral load \<50 c/ml who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA \<50 c/ml, prematurely discontinued (DC) study or study medication (any reason), had confirmed rebound to \>=50 c/ml, or had an unconfirmed HIV RNA \>=50 c/ml at last visit. ITT-E observed analysis (Obs): all observed data. ITT-E M/D=F analysis: PAR with missing data/data collected after study medication DC were failures. |
| Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 84 Visit | Week 84 | A blood sample was drawn to determine the amount of HIV-1 RNA virus in c/ml at Week 84. The percentage of participants with HIV-1 RNA \<50 c/ml at Week 84 was tabulated. The secondary analysis methods were: Observed (Obs; uses all visits with data in the analysis period), and missing/discontinuation=failure (M/D=F) analyses. M/D=F: participants with missing data or data collected after study medication DC were considered failures. |
| Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 144 Visit | Week 144 | Percentage of PAR with HIV-1 RNA \<50 c/ml at Week 144 was tabulated; stratified by baseline HIV-1 RNA (\<100,000 and \>=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV RNA \<50 c/ml who had not met any non-responder (NR) criterion. NR were PAR who never achieved CF HIV RNA \<50 c/ml, prematurely discontinued (DC) study or study medication (Med), had CF rebound to \>=50 c/ml, or had an unconfirmed HIV RNA \>=50 c/ml at last visit. Observed analysis (Obs): all observed data. M/D=F analysis: PAR with missing data/data collected after study Med DC were failures. |
| Percentage of Participants Who Achieved Plasma HIV-1 RNA <400 c/ml at the Week 36 Visit | Week 36 | The percentage of PAR with HIV-1 RNA virus \<400 c/ml from a Week 36 blood sample was tabulated. Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV RNA \<400 c/ml who had not met any non-responder criterion. Non-responders were PAR who never achieved CF HIV RNA \<400 c/ml, prematurely discontinued (DC) study or study medication (Med; any reason), had CF rebound to \>=400 c/ml, or had an unconfirmed HIV RNA \>=400 c/ml at last visit. ITT-E observed analysis (Obs): all observed data. ITT-E M/D=F analysis: PAR with missing data/data collected after study Med DC were failures. |
| Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 84 Visit | Week 84 | Percentage of PAR with HIV-1 RNA \<400 c/ml at Week 84 was tabulated; stratified by baseline HIV-1 RNA (\<100,000 and \>=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV-RNA \<400 c/ml who had not met any non-responder (NR) criterion. NR were PAR who never achieved CF HIV RNA \<400 c/ml, prematurely discontinued (DC) study or study medication (Med), had CF rebound to \>=400 c/ml, or had an unconfirmed HIV RNA \>=400 c/ml at last visit. Observed analysis (Obs): all observed data. M/D=F analysis: PAR with missing data/data collected after study Med DC were failures. |
| Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 144 Visit | Week 144 | Percentage of PAR with HIV-1 RNA \<400 c/ml at Week 144 was tabulated; stratified by baseline HIV-1 RNA (\<100,000 and \>=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV-RNA \<400 c/ml who had not met any non-responder (NR) criterion. NR were PAR who never achieved CF HIV RNA \<400 c/ml, prematurely discontinued (DC) study or study medication (Med), had CF rebound to \>=400 c/ml, or had an unconfirmed HIV RNA \>=400 c/ml at last visit. Observed analysis (Obs): all observed data. M/D=F analysis: PAR with missing data/data collected after study Med DC were failures. |
| Number of Participants Who Met the Protocol-defined Virologic Failure (PDVF) Criteria at Week 36 | Week 36 | The number of participants that failed to respond to therapy through 36 weeks on treatment, based on the protocol definition of virologic failure (PDVF), was tabulated. PDVF was defined as (a) failure to achieve plasma HIV-1 RNA \<400 c/ml by Week 30 or (b) confirmed HIV-1 RNA rebound \>=400 c/ml after achieving HIV-1 \<400 c/ml. |
| Number of Participants Who Met the PDVF Criteria at Week 84 | Week 84 | The number of participants that failed to respond to therapy from the time of treatment randomization through Week 84, based on the protocol definition of virologic failure (PDVF), was tabulated. PDVF was defined as (a) failure to achieve plasma HIV-1 RNA \<400 c/ml by Week 30 or (b) confirmed HIV-1 RNA rebound \>=400 c/ml after achieving HIV-1 \<400 c/ml. |
| Number of Participants Who Met the PDVF Criteria at Week 144 | Week 144 | The number of participants enrolled in the extension phase that failed to respond to therapy from Week 84 through Week 144, based on the protocol definition of virologic failure (PDVF) was tabulated,. PDVF was defined as (a) failure to achieve plasma HIV-1 RNA \<400 c/ml by Week 30 or (b) confirmed HIV-1 RNA rebound \>=400 c/ml after achieving HIV-1 \<400 c/ml. |
| Change From Baseline in HIV-1 RNA at Week 36 | Baseline and Week 36 | Change from baseline was calculated as the Week 36 value minus the baseline value. Blood was drawn to analyze for plasma HIV viral load. |
| Change From Baseline in HIV-1 RNA at Week 84 | Baseline and Week 84 | Change from baseline was calculated as the Week 84 value minus the baseline value. Blood was drawn to analyze for plasma HIV viral load. |
| Change From Baseline in HIV-1 RNA at Week 144 | Baseline and Week 144 | Change from baseline was calculated as the Week 144 value minus the baseline value. Blood was drawn to analyze for plasma HIV viral load. |
| Mean Age at Baseline of Participants Randomized to Treatment for the 48-Week Randomized Phase | Baseline of Randomized Phase | The mean age of participants randomized to treatment in the Randomized Phase was calculated at Baseline. |
| Change From Baseline in CD4+ Cell Count at Week 84 | Baseline and Week 84 | A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from baseline was calculated as the Week 84 value minus the baseline value. Blood was drawn to analyze for CD4+ cell count. |
| Change From Baseline in CD4+ Cell Count at Week 144 | Baseline and Week 144 | A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from baseline was calculated as the Week 144 value minus the baseline value. Blood was drawn to analyze for CD4+ cell count. |
| Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 36 | Baseline through Week 36 | A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New resistance-associated mutations (defined by the International AIDS Society-USA guidelines) that developed at the time of failure were tabulated by drug class. PAR, participants; VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. |
| Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Randomization at Week 36 Through Week 84 | Randomization at Week 36 through Week 84 | A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDs Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. |
| Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Week 84 Through Week 144 | Week 84 through Week 144 | A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDs Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. |
| Number of Confirmed Virologic Failure Participants From Baseline Through Week 36 With Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir | Baseline through Week 36 | A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at baseline. PAR, participant. |
| Number of Confirmed Virologic Failure Participants From Randomization at Week 36 Through Week 84 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir | Randomization at Week 36 through Week 84 | A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at baseline. PAR, participant. |
| Number of Confirmed Virologic Failure Participants From Week 84 Through Week 144 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir | Week 84 through Week 144 | A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at baseline. PAR, participant. |
| Mean Percent Compliance at Week 36 | Week 36 | Percent compliance is defined as the total number of pills taken divided by the total number of pills prescribed. The total number of pills taken was calculated by subtracting any returned pills from the total number of pills that were dispensed to each participant during this period. Compliance was calculated for each medication in the regimen. |
| Mean Percent Compliance at Week 84 | Week 84 | Percent compliance is defined as the total number of pills taken divided by the total number of pills prescribed. The total number of pills taken was calculated by subtracting any returned pills from the total number of pills that were dispensed to each participant during this period. Compliance was calculated for each medication in the regimen. |
| Mean Percent Compliance at Week 144 | Week 144 | Percent compliance is defined as the total number of pills taken divided by the total number of pills prescribed. The total number of pills taken was calculated by subtracting any returned pills from the total number of pills that were dispensed to each participant during this period. Compliance was calculated for each medication in the regimen. |
| Change From Baseline in CD4+ Cell Count at Week 36 | Baseline and Week 36 | Blood was drawn to analyze for CD4+ cell count. A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from baseline was calculated as the Week 36 value minus the baseline value. |
Countries
Canada, Puerto Rico, United States
Participant flow
Recruitment details
Participants (PAR) were recruited at 66 centers in the United States of America and Canada. HIV-RNA, human immunodeficiency virus-ribonucleic acid; ml, milliliters.
Pre-assignment details
The study had a 36-week Non-randomized Induction Phase, followed by an 84-week Randomized Phase. All PAR completing 84 weeks were eligible to enter an optional 60-week extension phase (EP); some PAR chose not to continue in the EP. PAR whose HIV-RNA wasn't \<50 copies/ml before Week 36 weren't allowed to randomize at Week 36 and were withdrawn.
Participants by arm
| Arm | Count |
|---|---|
| ABC/3TC + ATV/r All participants starting the Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis) | 515 |
| Total | 515 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| 36-Week Induction Phase | Adverse Event | 16 | 0 | 0 | 0 | 0 |
| 36-Week Induction Phase | Fleeing Police; Outstanding Warrants | 1 | 0 | 0 | 0 | 0 |
| 36-Week Induction Phase | Genotype Had Exclusionary Mutations | 1 | 0 | 0 | 0 | 0 |
| 36-Week Induction Phase | Incarceration | 3 | 0 | 0 | 0 | 0 |
| 36-Week Induction Phase | Insufficient Viral Load Response | 11 | 0 | 0 | 0 | 0 |
| 36-Week Induction Phase | Kaposi Lesions Requiring Chemotherapy | 1 | 0 | 0 | 0 | 0 |
| 36-Week Induction Phase | Lost to Follow-up | 16 | 0 | 0 | 0 | 0 |
| 36-Week Induction Phase | Non-compliance | 10 | 0 | 0 | 0 | 0 |
| 36-Week Induction Phase | Pregnancy | 1 | 0 | 0 | 0 | 0 |
| 36-Week Induction Phase | Protocol-defined Virologic Failure | 5 | 0 | 0 | 0 | 0 |
| 36-Week Induction Phase | Took Exclusionary Medications | 1 | 0 | 0 | 0 | 0 |
| 36-Week Induction Phase | Withdrawal by Subject | 7 | 0 | 0 | 0 | 0 |
| 48-Week Randomization Phase | Adverse Event | 0 | 2 | 5 | 0 | 0 |
| 48-Week Randomization Phase | Incarceration | 0 | 3 | 0 | 0 | 0 |
| 48-Week Randomization Phase | Lost to Follow-up | 0 | 2 | 8 | 0 | 0 |
| 48-Week Randomization Phase | Non-compliance | 0 | 3 | 4 | 0 | 0 |
| 48-Week Randomization Phase | Physician Decision | 0 | 2 | 0 | 0 | 0 |
| 48-Week Randomization Phase | Pregnancy | 0 | 0 | 1 | 0 | 0 |
| 48-Week Randomization Phase | Protocol-defined Virologic Failure | 0 | 1 | 1 | 0 | 0 |
| 48-Week Randomization Phase | Protocol Violation | 0 | 0 | 1 | 0 | 0 |
| 48-Week Randomization Phase | Trying to Get Pregnant | 0 | 1 | 0 | 0 | 0 |
| 48-Week Randomization Phase | Withdrawal by Subject | 0 | 2 | 4 | 0 | 0 |
| Optional 60-Week Extension Phase | Adverse Event | 0 | 0 | 0 | 1 | 3 |
| Optional 60-Week Extension Phase | Insufficient Viral Load Response | 0 | 0 | 0 | 1 | 1 |
| Optional 60-Week Extension Phase | Lost to Follow-up | 0 | 0 | 0 | 9 | 9 |
| Optional 60-Week Extension Phase | Non-compliance | 0 | 0 | 0 | 1 | 1 |
| Optional 60-Week Extension Phase | Other | 0 | 0 | 0 | 1 | 0 |
| Optional 60-Week Extension Phase | Participant Moved | 0 | 0 | 0 | 1 | 1 |
| Optional 60-Week Extension Phase | Participant Remained in Cuba | 0 | 0 | 0 | 0 | 1 |
| Optional 60-Week Extension Phase | Physician Decision | 0 | 0 | 0 | 0 | 1 |
| Optional 60-Week Extension Phase | Pregnancy | 0 | 0 | 0 | 3 | 0 |
| Optional 60-Week Extension Phase | Protocol-defined Virologic Failure | 0 | 0 | 0 | 3 | 2 |
| Optional 60-Week Extension Phase | Protocol Violation | 0 | 0 | 0 | 1 | 0 |
| Optional 60-Week Extension Phase | Sponsor Request | 0 | 0 | 0 | 1 | 1 |
| Optional 60-Week Extension Phase | Sponsor Terminated Site | 0 | 0 | 0 | 3 | 3 |
| Optional 60-Week Extension Phase | Withdrawal by Subject | 0 | 0 | 0 | 4 | 3 |
Baseline characteristics
| Characteristic | ABC/3TC + ATV/r |
|---|---|
| Age Continuous | 38.3 Years STANDARD_DEVIATION 10.03 |
| Median Baseline CD4+ Cell Count | 199 cells per cubic millimeter |
| Median Baseline HIV-1 RNA Level | 5.076 log10 copies/ml |
| Number of participants with the indicated Baseline CD4+ Cell Count CD4+ cells >=200 | 256 participants |
| Number of participants with the indicated Baseline CD4+ Cell Count CD4+ cells <50 | 69 participants |
| Number of participants with the indicated Baseline CD4+ Cell Count CD4+ cells 50-<200 | 190 participants |
| Number of participants with the indicated baseline HIV-RNA level HIV-1 RNA <100,000 | 227 participants |
| Number of participants with the indicated baseline HIV-RNA level HIV-1 RNA 100,000-<250,000 | 143 participants |
| Number of participants with the indicated baseline HIV-RNA level HIV-1 RNA 250,000-<500,000 | 73 participants |
| Number of participants with the indicated baseline HIV-RNA level HIV-1 RNA >=500,000 | 72 participants |
| Number of participants with the indicated Center for Disease Control (CDC) Classification AIDS | 65 participants |
| Number of participants with the indicated Center for Disease Control (CDC) Classification Asymptomatic HIV Infection | 353 participants |
| Number of participants with the indicated Center for Disease Control (CDC) Classification Symptomatic (non-AIDS) condition | 97 participants |
| Race/Ethnicity, Customized African American/African Heritage | 167 participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 9 participants |
| Race/Ethnicity, Customized Asian - Central/South Asian Heritage | 4 participants |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 3 participants |
| Race/Ethnicity, Customized Asian - Japanese Heritage | 1 participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 3 participants |
| Race/Ethnicity, Customized Mixed Race | 6 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 participants |
| Race/Ethnicity, Customized White - Arabic/North African Heritage | 5 participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 316 participants |
| Sex: Female, Male Female | 86 Participants |
| Sex: Female, Male Male | 429 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 237 / 515 | 116 / 210 | 123 / 209 | 123 / 189 | 130 / 180 |
| serious Total, serious adverse events | 39 / 515 | 22 / 210 | 22 / 209 | 24 / 189 | 24 / 180 |
Outcome results
Primary
Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c) /Milliliter (ml) at the Week 84 Visit
The percentage of PAR with HIV-1 RNA virus \<50 c/ml determined from a blood sample drawn at Week 84 was tabulated by treatment arm with stratification by baseline HIV-1 RNA (\<100,000 c/ml and \>=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed viral load \<50 c/ml who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA \<50 c/ml, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 50 c/ml, or had an unconfirmed HIV RNA of at least 50 c/ml at last visit.
Time frame: Week 84
Population: Intent-to-Treat (ITT)-Exposed Population, Randomized Phase: all PAR exposed to at least one dose of study medication during the Randomized Phase of the study. The primary analysis method was time to loss of virologic response (TLOVR) for the proportion of PAR with HIV-1 RNA \<50 c/ml at Week 84 in the Simplification arm and Continuation arms
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABC/3TC + ATV: Randomized Phase | Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c) /Milliliter (ml) at the Week 84 Visit | 86 percentage of participants |
| ABC/3TC + ATV/r: Randomized Phase | Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c) /Milliliter (ml) at the Week 84 Visit | 81 percentage of participants |
p-value: 0.1495% CI: [-1.8, 12.5]Cochran-Mantel-Haenszel
Secondary
Change From Baseline in CD4+ Cell Count at Week 144
A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from baseline was calculated as the Week 144 value minus the baseline value. Blood was drawn to analyze for CD4+ cell count.
Time frame: Baseline and Week 144
Population: ITT-Extension Population, Extension Phase. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 144 visit and had a cell count obtained during that visit period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABC/3TC + ATV: Randomized Phase | Change From Baseline in CD4+ Cell Count at Week 144 | 317.7 cells/millimeters cubed (mm^3) | Standard Deviation 161.98 |
| ABC/3TC + ATV/r: Randomized Phase | Change From Baseline in CD4+ Cell Count at Week 144 | 325.1 cells/millimeters cubed (mm^3) | Standard Deviation 178.29 |
Secondary
Change From Baseline in CD4+ Cell Count at Week 36
Blood was drawn to analyze for CD4+ cell count. A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from baseline was calculated as the Week 36 value minus the baseline value.
Time frame: Baseline and Week 36
Population: ITT-E Population, Induction Phase. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 36 visit and had a cell count obtained during that visit period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABC/3TC + ATV: Randomized Phase | Change From Baseline in CD4+ Cell Count at Week 36 | 185.4 cells/millimeters cubed (mm^3) | Standard Deviation 121.84 |
Secondary
Change From Baseline in CD4+ Cell Count at Week 84
A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from baseline was calculated as the Week 84 value minus the baseline value. Blood was drawn to analyze for CD4+ cell count.
Time frame: Baseline and Week 84
Population: ITT-E Population, Randomized Phase. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 84 visit and had a cell count obtained during that visit period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABC/3TC + ATV: Randomized Phase | Change From Baseline in CD4+ Cell Count at Week 84 | 265.7 cells/millimeters cubed (mm^3) | Standard Deviation 157.65 |
| ABC/3TC + ATV/r: Randomized Phase | Change From Baseline in CD4+ Cell Count at Week 84 | 282.9 cells/millimeters cubed (mm^3) | Standard Deviation 150.49 |
Secondary
Change From Baseline in HIV-1 RNA at Week 144
Change from baseline was calculated as the Week 144 value minus the baseline value. Blood was drawn to analyze for plasma HIV viral load.
Time frame: Baseline and Week 144
Population: ITT-Extension Population, Extension Phase. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 144 visit and had a viral load result obtained during that visit period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABC/3TC + ATV: Randomized Phase | Change From Baseline in HIV-1 RNA at Week 144 | -3.291 log10 c/ml | Standard Deviation 0.675 |
| ABC/3TC + ATV/r: Randomized Phase | Change From Baseline in HIV-1 RNA at Week 144 | -3.239 log10 c/ml | Standard Deviation 0.835 |
Secondary
Change From Baseline in HIV-1 RNA at Week 36
Change from baseline was calculated as the Week 36 value minus the baseline value. Blood was drawn to analyze for plasma HIV viral load.
Time frame: Baseline and Week 36
Population: ITT-E Population, Induction Phase. Observed Population. Participants could only be included in the analysis if they had completed a Week 36 visit and had a viral load result obtained during that visit period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABC/3TC + ATV: Randomized Phase | Change From Baseline in HIV-1 RNA at Week 36 | -3.241 log10 c/ml | Standard Deviation 0.775 |
Secondary
Change From Baseline in HIV-1 RNA at Week 84
Change from baseline was calculated as the Week 84 value minus the baseline value. Blood was drawn to analyze for plasma HIV viral load.
Time frame: Baseline and Week 84
Population: ITT-E Population, Randomized Phase. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 84 visit and had a viral load result obtained during that visit period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABC/3TC + ATV: Randomized Phase | Change From Baseline in HIV-1 RNA at Week 84 | -3.261 log10 c/ml | Standard Deviation 0.681 |
| ABC/3TC + ATV/r: Randomized Phase | Change From Baseline in HIV-1 RNA at Week 84 | -3.270 log10 c/ml | Standard Deviation 0.698 |
Secondary
Mean Age at Baseline of Participants Randomized to Treatment for the 48-Week Randomized Phase
The mean age of participants randomized to treatment in the Randomized Phase was calculated at Baseline.
Time frame: Baseline of Randomized Phase
Population: ITT-E Population: all participants exposed to at least one dose of study medication during the Randomized Simplification Phase
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABC/3TC + ATV: Randomized Phase | Mean Age at Baseline of Participants Randomized to Treatment for the 48-Week Randomized Phase | 37.5 years | Standard Deviation 10.23 |
| ABC/3TC + ATV/r: Randomized Phase | Mean Age at Baseline of Participants Randomized to Treatment for the 48-Week Randomized Phase | 39.7 years | Standard Deviation 9.71 |
Secondary
Mean Percent Compliance at Week 144
Percent compliance is defined as the total number of pills taken divided by the total number of pills prescribed. The total number of pills taken was calculated by subtracting any returned pills from the total number of pills that were dispensed to each participant during this period. Compliance was calculated for each medication in the regimen.
Time frame: Week 144
Population: ITT-Extension Population, Extension Phase. Participants with an unknown number of pills returned (including those whose pill bottles were not returned) were not included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABC/3TC + ATV: Randomized Phase | Mean Percent Compliance at Week 144 | Ritonavir | 93.3 percent compliance | Standard Deviation 11.07 |
| ABC/3TC + ATV: Randomized Phase | Mean Percent Compliance at Week 144 | Atazanavir | 99.1 percent compliance | Standard Deviation 4.54 |
| ABC/3TC + ATV: Randomized Phase | Mean Percent Compliance at Week 144 | Abacavir/Lamivudine | 92.0 percent compliance | Standard Deviation 12.65 |
| ABC/3TC + ATV/r: Randomized Phase | Mean Percent Compliance at Week 144 | Ritonavir | 90.1 percent compliance | Standard Deviation 14.58 |
| ABC/3TC + ATV/r: Randomized Phase | Mean Percent Compliance at Week 144 | Atazanavir | 91.4 percent compliance | Standard Deviation 13.99 |
| ABC/3TC + ATV/r: Randomized Phase | Mean Percent Compliance at Week 144 | Abacavir/Lamivudine | 90.1 percent compliance | Standard Deviation 15.35 |
Secondary
Mean Percent Compliance at Week 36
Percent compliance is defined as the total number of pills taken divided by the total number of pills prescribed. The total number of pills taken was calculated by subtracting any returned pills from the total number of pills that were dispensed to each participant during this period. Compliance was calculated for each medication in the regimen.
Time frame: Week 36
Population: ITT-E Population, Induction Phase. Participants with an unknown number of pills returned (including those whose pill bottles were not returned) were not included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABC/3TC + ATV: Randomized Phase | Mean Percent Compliance at Week 36 | Abacavir/Lamivudine | 92.2 percent compliance | Standard Deviation 13.05 |
| ABC/3TC + ATV: Randomized Phase | Mean Percent Compliance at Week 36 | Ritonavir | 92.3 percent compliance | Standard Deviation 12.15 |
| ABC/3TC + ATV: Randomized Phase | Mean Percent Compliance at Week 36 | Atazanavir | 92.7 percent compliance | Standard Deviation 12.5 |
Secondary
Mean Percent Compliance at Week 84
Percent compliance is defined as the total number of pills taken divided by the total number of pills prescribed. The total number of pills taken was calculated by subtracting any returned pills from the total number of pills that were dispensed to each participant during this period. Compliance was calculated for each medication in the regimen.
Time frame: Week 84
Population: ITT-E Population, Randomized Phase. Participants with an unknown number of pills returned (including those whose pill bottles were not returned) were not included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABC/3TC + ATV: Randomized Phase | Mean Percent Compliance at Week 84 | Abacavir/Lamivudine | 92.0 percent compliance | Standard Deviation 11.62 |
| ABC/3TC + ATV: Randomized Phase | Mean Percent Compliance at Week 84 | Ritonavir | 92.9 percent compliance | Standard Deviation 11.64 |
| ABC/3TC + ATV: Randomized Phase | Mean Percent Compliance at Week 84 | Atazanavir | 98.9 percent compliance | Standard Deviation 5.32 |
| ABC/3TC + ATV/r: Randomized Phase | Mean Percent Compliance at Week 84 | Abacavir/Lamivudine | 91.2 percent compliance | Standard Deviation 13.49 |
| ABC/3TC + ATV/r: Randomized Phase | Mean Percent Compliance at Week 84 | Ritonavir | 91.5 percent compliance | Standard Deviation 12.23 |
| ABC/3TC + ATV/r: Randomized Phase | Mean Percent Compliance at Week 84 | Atazanavir | 92.4 percent compliance | Standard Deviation 11.89 |
Secondary
Number of Confirmed Virologic Failure Participants From Baseline Through Week 36 With Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir
A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at baseline. PAR, participant.
Time frame: Baseline through Week 36
Population: Participants in the ITT-E Population (Induction Phase) who met the confirmed virologic failure (CVF) criteria with paired baseline and virologic failure phenotypic evaluations. One participant met CVF criteria at Week 36 and was randomized; these results are included in both the Week 36 and the Randomization through Week 84 results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC + ATV: Randomized Phase | Number of Confirmed Virologic Failure Participants From Baseline Through Week 36 With Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir | PAR with reduced abacavir susceptibility | 0 participants |
| ABC/3TC + ATV: Randomized Phase | Number of Confirmed Virologic Failure Participants From Baseline Through Week 36 With Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir | PAR with reduced lamivudine susceptibility | 1 participants |
| ABC/3TC + ATV: Randomized Phase | Number of Confirmed Virologic Failure Participants From Baseline Through Week 36 With Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir | PAR with reduced atazanavir susceptibility | 0 participants |
| ABC/3TC + ATV: Randomized Phase | Number of Confirmed Virologic Failure Participants From Baseline Through Week 36 With Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir | PAR with reduced ritonavir susceptibility | 0 participants |
Secondary
Number of Confirmed Virologic Failure Participants From Randomization at Week 36 Through Week 84 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir
A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at baseline. PAR, participant.
Time frame: Randomization at Week 36 through Week 84
Population: Participants in the ITT-E population (Randomized Phase) who met the confirmed virologic failure (CVF) criteria with paired baseline and virologic failure phenotypic evaluations. One participant met CVF criteria at Week 36 and was randomized; these results are included in both the Week 36 and the Randomization through Week 84 results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC + ATV: Randomized Phase | Number of Confirmed Virologic Failure Participants From Randomization at Week 36 Through Week 84 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir | PAR with reduced abacavir susceptibility | 0 participants |
| ABC/3TC + ATV: Randomized Phase | Number of Confirmed Virologic Failure Participants From Randomization at Week 36 Through Week 84 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir | PAR with reduced lamivudine susceptibility | 1 participants |
| ABC/3TC + ATV: Randomized Phase | Number of Confirmed Virologic Failure Participants From Randomization at Week 36 Through Week 84 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir | PAR with reduced atazanavir susceptibility | 0 participants |
| ABC/3TC + ATV: Randomized Phase | Number of Confirmed Virologic Failure Participants From Randomization at Week 36 Through Week 84 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir | PAR with reduced ritonavir susceptibility | 0 participants |
| ABC/3TC + ATV/r: Randomized Phase | Number of Confirmed Virologic Failure Participants From Randomization at Week 36 Through Week 84 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir | PAR with reduced ritonavir susceptibility | 0 participants |
| ABC/3TC + ATV/r: Randomized Phase | Number of Confirmed Virologic Failure Participants From Randomization at Week 36 Through Week 84 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir | PAR with reduced abacavir susceptibility | 0 participants |
| ABC/3TC + ATV/r: Randomized Phase | Number of Confirmed Virologic Failure Participants From Randomization at Week 36 Through Week 84 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir | PAR with reduced atazanavir susceptibility | 0 participants |
| ABC/3TC + ATV/r: Randomized Phase | Number of Confirmed Virologic Failure Participants From Randomization at Week 36 Through Week 84 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir | PAR with reduced lamivudine susceptibility | 0 participants |
Secondary
Number of Confirmed Virologic Failure Participants From Week 84 Through Week 144 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir
A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at baseline. PAR, participant.
Time frame: Week 84 through Week 144
Population: Participants in the ITT-Extension Population (Extension Phase) who met the confirmed virologic failure criteria with paired baseline and virologic failure phenotypic evaluations
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC + ATV: Randomized Phase | Number of Confirmed Virologic Failure Participants From Week 84 Through Week 144 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir | PAR with reduced abacavir susceptibility | 0 participants |
| ABC/3TC + ATV: Randomized Phase | Number of Confirmed Virologic Failure Participants From Week 84 Through Week 144 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir | PAR with reduced lamivudine susceptibility | 1 participants |
| ABC/3TC + ATV: Randomized Phase | Number of Confirmed Virologic Failure Participants From Week 84 Through Week 144 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir | PAR with reduced atazanavir susceptibility | 0 participants |
| ABC/3TC + ATV: Randomized Phase | Number of Confirmed Virologic Failure Participants From Week 84 Through Week 144 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir | PAR with reduced ritonavir susceptibility | 0 participants |
| ABC/3TC + ATV/r: Randomized Phase | Number of Confirmed Virologic Failure Participants From Week 84 Through Week 144 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir | PAR with reduced ritonavir susceptibility | 1 participants |
| ABC/3TC + ATV/r: Randomized Phase | Number of Confirmed Virologic Failure Participants From Week 84 Through Week 144 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir | PAR with reduced abacavir susceptibility | 1 participants |
| ABC/3TC + ATV/r: Randomized Phase | Number of Confirmed Virologic Failure Participants From Week 84 Through Week 144 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir | PAR with reduced atazanavir susceptibility | 1 participants |
| ABC/3TC + ATV/r: Randomized Phase | Number of Confirmed Virologic Failure Participants From Week 84 Through Week 144 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir | PAR with reduced lamivudine susceptibility | 1 participants |
Secondary
Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 36
A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New resistance-associated mutations (defined by the International AIDS Society-USA guidelines) that developed at the time of failure were tabulated by drug class. PAR, participants; VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.
Time frame: Baseline through Week 36
Population: Participants in the ITT-E Population (Induction Phase) who met the confirmed virologic failure (CVF) criteria with paired baseline and virologic failure genotypic evaluations. One participant met CVF criteria at Week 36 and was randomized; these results are included in both the Week 36 and the Randomization through Week 84 results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC + ATV: Randomized Phase | Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 36 | PAR with paired genotypes at baseline and VF | 15 participants |
| ABC/3TC + ATV: Randomized Phase | Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 36 | PAR with treatment-emergent mutations | 6 participants |
| ABC/3TC + ATV: Randomized Phase | Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 36 | PAR with NRTI mutations | 4 participants |
| ABC/3TC + ATV: Randomized Phase | Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 36 | PAR with NNRTI mutations | 1 participants |
| ABC/3TC + ATV: Randomized Phase | Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 36 | PAR with major PI mutations | 0 participants |
| ABC/3TC + ATV: Randomized Phase | Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 36 | PAR with minor PI mutations | 2 participants |
Secondary
Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Randomization at Week 36 Through Week 84
A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDs Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.
Time frame: Randomization at Week 36 through Week 84
Population: Participants in the ITT-E Population (Randomized Phase) who met the confirmed virologic failure (CVF) criteria with paired baseline and virologic failure genotypic evaluations. One participant met CVF criteria at Week 36 and was randomized; these results are included in both the Week 36 and the Randomization through Week 84 results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC + ATV: Randomized Phase | Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Randomization at Week 36 Through Week 84 | PAR with paired genotypes at baseline and VF | 1 participants |
| ABC/3TC + ATV: Randomized Phase | Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Randomization at Week 36 Through Week 84 | PAR with treatment-emergent mutations | 1 participants |
| ABC/3TC + ATV: Randomized Phase | Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Randomization at Week 36 Through Week 84 | PAR with NRTI mutations | 1 participants |
| ABC/3TC + ATV: Randomized Phase | Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Randomization at Week 36 Through Week 84 | PAR with NNRTI mutations | 0 participants |
| ABC/3TC + ATV: Randomized Phase | Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Randomization at Week 36 Through Week 84 | PAR with major PI mutations | 0 participants |
| ABC/3TC + ATV: Randomized Phase | Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Randomization at Week 36 Through Week 84 | PAR with minor PI mutations | 0 participants |
| ABC/3TC + ATV/r: Randomized Phase | Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Randomization at Week 36 Through Week 84 | PAR with major PI mutations | 0 participants |
| ABC/3TC + ATV/r: Randomized Phase | Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Randomization at Week 36 Through Week 84 | PAR with paired genotypes at baseline and VF | 7 participants |
| ABC/3TC + ATV/r: Randomized Phase | Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Randomization at Week 36 Through Week 84 | PAR with NNRTI mutations | 0 participants |
| ABC/3TC + ATV/r: Randomized Phase | Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Randomization at Week 36 Through Week 84 | PAR with treatment-emergent mutations | 2 participants |
| ABC/3TC + ATV/r: Randomized Phase | Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Randomization at Week 36 Through Week 84 | PAR with minor PI mutations | 2 participants |
| ABC/3TC + ATV/r: Randomized Phase | Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Randomization at Week 36 Through Week 84 | PAR with NRTI mutations | 0 participants |
Secondary
Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Week 84 Through Week 144
A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDs Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.
Time frame: Week 84 through Week 144
Population: Participants in the ITT-Extension Population (Extension Phase) who met the confirmed virologic failure criteria with paired baseline and virologic failure genotypic evaluations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC + ATV: Randomized Phase | Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Week 84 Through Week 144 | PAR with NNRTI mutations | 0 participants |
| ABC/3TC + ATV: Randomized Phase | Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Week 84 Through Week 144 | PAR with NRTI mutations | 0 participants |
| ABC/3TC + ATV: Randomized Phase | Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Week 84 Through Week 144 | PAR with major PI mutations | 0 participants |
| ABC/3TC + ATV: Randomized Phase | Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Week 84 Through Week 144 | PAR with treatment-emergent mutations | 2 participants |
| ABC/3TC + ATV: Randomized Phase | Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Week 84 Through Week 144 | PAR with minor PI mutations | 2 participants |
| ABC/3TC + ATV: Randomized Phase | Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Week 84 Through Week 144 | PAR with paired genotypes at baseline and VF | 5 participants |
| ABC/3TC + ATV/r: Randomized Phase | Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Week 84 Through Week 144 | PAR with minor PI mutations | 1 participants |
| ABC/3TC + ATV/r: Randomized Phase | Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Week 84 Through Week 144 | PAR with paired genotypes at baseline and VF | 5 participants |
| ABC/3TC + ATV/r: Randomized Phase | Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Week 84 Through Week 144 | PAR with NRTI mutations | 1 participants |
| ABC/3TC + ATV/r: Randomized Phase | Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Week 84 Through Week 144 | PAR with NNRTI mutations | 0 participants |
| ABC/3TC + ATV/r: Randomized Phase | Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Week 84 Through Week 144 | PAR with major PI mutations | 1 participants |
| ABC/3TC + ATV/r: Randomized Phase | Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Week 84 Through Week 144 | PAR with treatment-emergent mutations | 1 participants |
Secondary
Number of Participants Who Met the PDVF Criteria at Week 144
The number of participants enrolled in the extension phase that failed to respond to therapy from Week 84 through Week 144, based on the protocol definition of virologic failure (PDVF) was tabulated,. PDVF was defined as (a) failure to achieve plasma HIV-1 RNA \<400 c/ml by Week 30 or (b) confirmed HIV-1 RNA rebound \>=400 c/ml after achieving HIV-1 \<400 c/ml.
Time frame: Week 144
Population: ITT-Extension Population, Extension Phase. TLOVR.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC + ATV: Randomized Phase | Number of Participants Who Met the PDVF Criteria at Week 144 | Protocol-defined virologic failure | 5 participants |
| ABC/3TC + ATV: Randomized Phase | Number of Participants Who Met the PDVF Criteria at Week 144 | Confirmed rebound after achieving <400 c/ml | 5 participants |
| ABC/3TC + ATV/r: Randomized Phase | Number of Participants Who Met the PDVF Criteria at Week 144 | Protocol-defined virologic failure | 6 participants |
| ABC/3TC + ATV/r: Randomized Phase | Number of Participants Who Met the PDVF Criteria at Week 144 | Confirmed rebound after achieving <400 c/ml | 6 participants |
Secondary
Number of Participants Who Met the PDVF Criteria at Week 84
The number of participants that failed to respond to therapy from the time of treatment randomization through Week 84, based on the protocol definition of virologic failure (PDVF), was tabulated. PDVF was defined as (a) failure to achieve plasma HIV-1 RNA \<400 c/ml by Week 30 or (b) confirmed HIV-1 RNA rebound \>=400 c/ml after achieving HIV-1 \<400 c/ml.
Time frame: Week 84
Population: ITT-Exposed Population, Randomized Phase. TLOVR. One participant met PDVF criteria at Week 36 and was included in the Week 36 PDVF but had been randomized; this participant is therefore also included in this PDVF tabulation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC + ATV: Randomized Phase | Number of Participants Who Met the PDVF Criteria at Week 84 | Protocol-defined virologic failure | 1 participants |
| ABC/3TC + ATV: Randomized Phase | Number of Participants Who Met the PDVF Criteria at Week 84 | Confirmed rebound after achieving <400 c/ml | 1 participants |
| ABC/3TC + ATV/r: Randomized Phase | Number of Participants Who Met the PDVF Criteria at Week 84 | Protocol-defined virologic failure | 7 participants |
| ABC/3TC + ATV/r: Randomized Phase | Number of Participants Who Met the PDVF Criteria at Week 84 | Confirmed rebound after achieving <400 c/ml | 7 participants |
Secondary
Number of Participants Who Met the Protocol-defined Virologic Failure (PDVF) Criteria at Week 36
The number of participants that failed to respond to therapy through 36 weeks on treatment, based on the protocol definition of virologic failure (PDVF), was tabulated. PDVF was defined as (a) failure to achieve plasma HIV-1 RNA \<400 c/ml by Week 30 or (b) confirmed HIV-1 RNA rebound \>=400 c/ml after achieving HIV-1 \<400 c/ml.
Time frame: Week 36
Population: ITT-E Population, Induction Phase
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC + ATV: Randomized Phase | Number of Participants Who Met the Protocol-defined Virologic Failure (PDVF) Criteria at Week 36 | Protocol-defined virologic failure | 15 participants |
| ABC/3TC + ATV: Randomized Phase | Number of Participants Who Met the Protocol-defined Virologic Failure (PDVF) Criteria at Week 36 | Failure to achieve <400 c/ml by Week 30 | 5 participants |
| ABC/3TC + ATV: Randomized Phase | Number of Participants Who Met the Protocol-defined Virologic Failure (PDVF) Criteria at Week 36 | Confirmed rebound after achieving <400 c/ml | 10 participants |
Secondary
Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 144 Visit
Percentage of PAR with HIV-1 RNA \<400 c/ml at Week 144 was tabulated; stratified by baseline HIV-1 RNA (\<100,000 and \>=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV-RNA \<400 c/ml who had not met any non-responder (NR) criterion. NR were PAR who never achieved CF HIV RNA \<400 c/ml, prematurely discontinued (DC) study or study medication (Med), had CF rebound to \>=400 c/ml, or had an unconfirmed HIV RNA \>=400 c/ml at last visit. Observed analysis (Obs): all observed data. M/D=F analysis: PAR with missing data/data collected after study Med DC were failures.
Time frame: Week 144
Population: ITT-Extension Population, Extension Phase
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC + ATV: Randomized Phase | Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 144 Visit | TLOVR | 84 percentage of participants |
| ABC/3TC + ATV: Randomized Phase | Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 144 Visit | Obs | 99 percentage of participants |
| ABC/3TC + ATV: Randomized Phase | Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 144 Visit | M/D=F | 84 percentage of participants |
| ABC/3TC + ATV/r: Randomized Phase | Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 144 Visit | M/D=F | 82 percentage of participants |
| ABC/3TC + ATV/r: Randomized Phase | Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 144 Visit | TLOVR | 80 percentage of participants |
| ABC/3TC + ATV/r: Randomized Phase | Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 144 Visit | Obs | 97 percentage of participants |
Secondary
Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 84 Visit
Percentage of PAR with HIV-1 RNA \<400 c/ml at Week 84 was tabulated; stratified by baseline HIV-1 RNA (\<100,000 and \>=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV-RNA \<400 c/ml who had not met any non-responder (NR) criterion. NR were PAR who never achieved CF HIV RNA \<400 c/ml, prematurely discontinued (DC) study or study medication (Med), had CF rebound to \>=400 c/ml, or had an unconfirmed HIV RNA \>=400 c/ml at last visit. Observed analysis (Obs): all observed data. M/D=F analysis: PAR with missing data/data collected after study Med DC were failures.
Time frame: Week 84
Population: ITT-E Population, Randomized Phase
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC + ATV: Randomized Phase | Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 84 Visit | TLOVR | 92 percentage of participants |
| ABC/3TC + ATV: Randomized Phase | Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 84 Visit | Obs | 99 percentage of participants |
| ABC/3TC + ATV: Randomized Phase | Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 84 Visit | M/D=F | 92 percentage of participants |
| ABC/3TC + ATV/r: Randomized Phase | Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 84 Visit | TLOVR | 86 percentage of participants |
| ABC/3TC + ATV/r: Randomized Phase | Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 84 Visit | Obs | 98 percentage of participants |
| ABC/3TC + ATV/r: Randomized Phase | Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 84 Visit | M/D=F | 87 percentage of participants |
Secondary
Percentage of Participants Who Achieved Plasma HIV-1 RNA <400 c/ml at the Week 36 Visit
The percentage of PAR with HIV-1 RNA virus \<400 c/ml from a Week 36 blood sample was tabulated. Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV RNA \<400 c/ml who had not met any non-responder criterion. Non-responders were PAR who never achieved CF HIV RNA \<400 c/ml, prematurely discontinued (DC) study or study medication (Med; any reason), had CF rebound to \>=400 c/ml, or had an unconfirmed HIV RNA \>=400 c/ml at last visit. ITT-E observed analysis (Obs): all observed data. ITT-E M/D=F analysis: PAR with missing data/data collected after study Med DC were failures.
Time frame: Week 36
Population: ITT-E Population, Induction Phase
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC + ATV: Randomized Phase | Percentage of Participants Who Achieved Plasma HIV-1 RNA <400 c/ml at the Week 36 Visit | TLOVR | 82 percentage of participants |
| ABC/3TC + ATV: Randomized Phase | Percentage of Participants Who Achieved Plasma HIV-1 RNA <400 c/ml at the Week 36 Visit | Obs | 98 percentage of participants |
| ABC/3TC + ATV: Randomized Phase | Percentage of Participants Who Achieved Plasma HIV-1 RNA <400 c/ml at the Week 36 Visit | M/D=F | 84 percentage of participants |
Secondary
Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 144 Visit
Percentage of PAR with HIV-1 RNA \<50 c/ml at Week 144 was tabulated; stratified by baseline HIV-1 RNA (\<100,000 and \>=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV RNA \<50 c/ml who had not met any non-responder (NR) criterion. NR were PAR who never achieved CF HIV RNA \<50 c/ml, prematurely discontinued (DC) study or study medication (Med), had CF rebound to \>=50 c/ml, or had an unconfirmed HIV RNA \>=50 c/ml at last visit. Observed analysis (Obs): all observed data. M/D=F analysis: PAR with missing data/data collected after study Med DC were failures.
Time frame: Week 144
Population: ITT-Extension Population, Extension Phase: all participants exposed to at least one dose of study medication during the Extension Phase of the study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC + ATV: Randomized Phase | Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 144 Visit | TLOVR | 77 percentage of participants |
| ABC/3TC + ATV: Randomized Phase | Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 144 Visit | Obs | 95 percentage of participants |
| ABC/3TC + ATV: Randomized Phase | Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 144 Visit | M/D=F | 80 percentage of participants |
| ABC/3TC + ATV/r: Randomized Phase | Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 144 Visit | TLOVR | 73 percentage of participants |
| ABC/3TC + ATV/r: Randomized Phase | Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 144 Visit | Obs | 92 percentage of participants |
| ABC/3TC + ATV/r: Randomized Phase | Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 144 Visit | M/D=F | 78 percentage of participants |
Secondary
Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 36 Visit
The percentage of PAR with HIV-1 RNA virus \<50 c/ml from a Week 36 blood sample was tabulated. Per TLOVR algorithm, responders were PAR with confirmed viral load \<50 c/ml who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA \<50 c/ml, prematurely discontinued (DC) study or study medication (any reason), had confirmed rebound to \>=50 c/ml, or had an unconfirmed HIV RNA \>=50 c/ml at last visit. ITT-E observed analysis (Obs): all observed data. ITT-E M/D=F analysis: PAR with missing data/data collected after study medication DC were failures.
Time frame: Week 36
Population: ITT-E Population, Induction Phase: all participants exposed to at least one dose of study medication during the Induction Phase of the study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC + ATV: Randomized Phase | Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 36 Visit | TLOVR | 80 percentage of participants |
| ABC/3TC + ATV: Randomized Phase | Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 36 Visit | Obs | 88 percentage of participants |
| ABC/3TC + ATV: Randomized Phase | Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 36 Visit | M/D=F | 77 percentage of participants |
Secondary
Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 84 Visit
A blood sample was drawn to determine the amount of HIV-1 RNA virus in c/ml at Week 84. The percentage of participants with HIV-1 RNA \<50 c/ml at Week 84 was tabulated. The secondary analysis methods were: Observed (Obs; uses all visits with data in the analysis period), and missing/discontinuation=failure (M/D=F) analyses. M/D=F: participants with missing data or data collected after study medication DC were considered failures.
Time frame: Week 84
Population: ITT-E Population, Randomized Phase. The secondary analysis methods were Observed (Obs) and missing/discontinuation=failure (M/D=F) analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC + ATV: Randomized Phase | Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 84 Visit | Obs | 92 percentage of participants |
| ABC/3TC + ATV: Randomized Phase | Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 84 Visit | M/D=F | 85 percentage of participants |
| ABC/3TC + ATV/r: Randomized Phase | Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 84 Visit | Obs | 92 percentage of participants |
| ABC/3TC + ATV/r: Randomized Phase | Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 84 Visit | M/D=F | 82 percentage of participants |