Infection, Human Immunodeficiency Virus
Conditions
Keywords
HIV-1, HIV
Brief summary
This study is designed to compare the efficacy and safety of simplifying therapy from a regimen of atazanavir (ATV) + ritonavir (RTV) + tenofovir/emtricitabine (TDF/FTC) to a regimen of ATV + abacavir sulfate/lamivudine (ABC/3TC) without RTV in virologically suppressed, HIV-1 infected, HLA-B\*5701 negative subjects for 48 weeks.
Detailed description
A prospective, randomized, multicenter, open-label study to compare the efficacy and safety of simplifying from a regimen of atazanavir (ATV) + ritonavir (RTV) + tenofovir/emtricitabine (TDF/FTC) to ATV + abacavir sulfate/lamivudine (ABC/3TC) without RTV for 48 weeks in virologically suppressed, HIV-1 infected, HLA-B\*5701 negative subjects. ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.
Interventions
DRUGReyataz + Norvir + Truvada
atazanavir 300mg + ritonavir 100mg + tenofovir 300mg/emtricitabine 200mg
DRUGReyataz + Epzicom
atazanavir 400mg + abacavir 600mg/lamivudine 300mg
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 an adult (greater than or equal to 18 years) with documented HIV-1 infection * Subject is a male or female of non-childbearing potential (physiologically incapable of becoming pregnant, is pre-menarchal or post-menopausal) or child-bearing potential with a negative pregnancy test who agrees to avoid pregnancy by sexual abstinence or utilization of a highly effective method of birth control throughout the study period * Subject is receiving a once-daily regimen of ATV (300mg) + RTV (100mg) + TDF/FTC (300mg/200mg) for at least 6 months prior to or by the first day of screening. ATV + RTV + TDF/FTC must be the subejct's INITIAL regimen or FIRST or SECOND SWITCH regimen. If ATV + RTV + TDF/FTC is subject's first or second switch regimen, then subject may ONLY have received the following prior regimens: a) any currently licensed non-nucleoside reverse transcriptase inhibitor (NNRTI) + TDF/FTC or ZDV/3TC; b) RTV-boosted PI with TDF/FTC or ZDV/3TC; or c) an alternative regimen not listed above after approval by Sponsor. * Subject is virologically suppressed on ATV + RTV + TDF/FTC defined as HIV-1 RNA \</=75 copies/mL at 2 consecutive timepoints, one of which is at Screening and the other at least 28 days prior to Screening
Exclusion criteria
* Subject has evidence of virologic failure * Subject has any known HIV genotyping results indicating HIV virus contains any of the following resistance mutations in reverse transcriptase including K65R, K70E, L74V, M184I/V or Y115F, a combination of two or more thymidine analog mutations including M41L, D67N, K70R, K219Q or E that include changes at either L210 or T215), or 3 or more of the following HIV-1 protease mutations associated with atazanavir resistance: D30, V32, M36, M46, I47, G48, I50, I54, A71, G73, V77, V82, I84, N88, and L90 * Subject is HLA-B\*5701 positive * Subject has hypersensitivity to any component of the study drugs * SUbject is pregnant or breastfeeding * Subject is enrolled in one or more investigational drug protocols within 30 days of screening * Subject has an active Center for Disease Control and Prevention (CDC) Category C disease, except cutaneous Kaposi's sarcoma not requiring systemic therapy during the trial * Subject has ongoing clinically relevant hepatitis at screening and/or positive for Hepatitis B (+ HbsAg) * Subject has a creatinine clearance \<50 mL/min via the Cockcroft-Gault method * Subject has a verified Grade 4 laboratory abnormality at screening unless the Investigator can provide a compelling explanation (e.g. elevated CPK due to exercise) for the laboratory result(s) and has the assent of the Sponsor * Subject has any other laboratory abnormality or medical condition at screening, which, in the opinion of the investigator, would preclude the subject's participation in the study * Subject has had an immunization within 30 days prior to first dose of investigational product * Subject has had any exposure to treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, or interferons) or receipt of an HIV-1 immunotherapeutic vaccine within 90 days prior to screening. Subjects using inhaled corticosteroids or short-course systemic corticosteroids (less than or equal to 14 days) are eligible for enrollment. * Subject has had treatment with radiation therapy or cytotoxic chemotherapeutic agents within 90 days prior to screening, or has an anticipated need for these agents within the study period * Subject has had treatment within 30 days prior to first dose of investigational product for or an anticipated need during the study of any medications which can have interactions with the study medications, TDF, FTC, ABC, 3TC, ATV and/or RTV, as described in current product labelling * Subject has had treatment with any previous abacavir-containing regimen
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 24 Visit: TLOVR Analysis | Week 24 | The percentage of PAR with HIV-1 RNA virus \<50 c/mL determined from blood samples drawn at Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment. 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 the last visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 48 Visit: TLOVR, Observed, M/D=F, and SNAPSHOT Analyses | Week 48 | The percentage of PAR with HIV-1 RNA virus \<50 c/mL determined from blood samples drawn at Week 48 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods. |
| Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: TLOVR Analysis | Week 24 | The percentage of PAR with HIV-1 RNA virus \<400 c/mL determined from blood samples drawn at Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment. Per TLOVR algorithm, responders were PAR with confirmed viral load \<400 c/mL who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA \<400 c/mL, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 400 c/mL, or had an unconfirmed HIV RNA of at least 400 c/mL at the last visit. |
| Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: TLOVR Analysis | Week 48 | The percentage of PAR with HIV-1 RNA virus \<400 c/mL determined from blood samples drawn at Week 48 was tabulated by treatment arm with stratification by initial antiretroviral treatment. Per TLOVR algorithm, responders were PAR with confirmed viral load \<400 c/mL who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA \<400 c/mL, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 400 c/mL, or had an unconfirmed HIV RNA of at least 400 c/mL at the last visit. |
| Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: Observed, MD=F, and SNAPSHOT Analyses | Week 24 | The percentage of PAR with HIV-1 RNA virus \<400 c/mL determined from blood samples drawn at Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods. |
| Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: Observed, MD=F, and SNAPSHOT Analyses | Week 48 | The percentage of PAR with HIV-1 RNA virus \<400 c/mL determined from blood samples drawn at Week 48 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods. |
| Change From Baseline in HIV-1 RNA at Week 24 | Baseline and Week 24 | Change from Baseline was calculated as the Week 24 value minus the Baseline value. Blood was drawn to analyze for plasma HIV viral load. |
| Change From Baseline in HIV-1 RNA at Week 48 | Baseline and Week 48 | Change from Baseline was calculated as the Week 48 value minus the Baseline value. Blood was drawn to analyze for plasma HIV viral load. |
| Change From Baseline in CD4+ Cell Count at Week 24 | Baseline and Week 24 | 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 24 value minus the Baseline value. |
| Change From Baseline in CD4+ Cell Count at Week 48 | Baseline and Week 48 | 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 48 value minus the Baseline value. |
| Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 24 | Baseline and Week 24 | Triglycerides, total cholesterol, HDL cholesterol, and LDL cholesterol levels were measured at Week 24. A Fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 24 value minus the Baseline value for each parameter. |
| Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 24 Visit: Observed, M/D=F, and SNAPSHOT Analyses | Week 24 | The percentage of PAR with HIV-1 RNA virus \<50 c/mL determined from blood samples drawn through Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods. |
| Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 48 | Baseline and Week 48 | Triglycerides, total cholesterol, HDL cholesterol, and LDL cholesterol levels were measured or calculated at Week 48. A fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 48 value minus the Baseline value for each parameter. |
| Change From Baseline in Cholesterol/HDL Ratio at Week 48 | Baseline and Week 48 | A fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 48 value minus the Baseline value for each parameter. |
| Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 24 | From Baseline to Week 24 | The number of participants that failed to remain virologically suppressed through 24 weeks on treatment was assessed. Viral failure is defined per protocol as confirmed HIV-1 RNA \>=400 c/mL. |
| Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 48 | From Baseline to Week 48 | The number of participants that failed to remain virologically suppressed from baseline through 48 weeks on treatment was assessed. Viral failure is defined per protocol as confirmed HIV-1 RNA \>=400 c/mL. |
| Number of Participants Who Experienced Death and/or Disease Progression | From Baseline to Week 48 | Death and clinical disease progression (as per CDC classification) were assessed from Baseline through Week 48. Disease progression is defined as progression from CDC Class A to B, Class A to C, or from Class B to C. AIDS CDC classifications are: Class A, Asymptomatic/lymphadenopathy/acute HIV; Class B, Symptomatic, not AIDS; Class C, AIDS indicator conditions. The CDC categorization of HIV/AIDS is based on the lowest documented CD4 cell count (Class A, \>=500 cells per microliter \[µl\]; Class B, 200-499 cells/µl; Class C, \<200 cells/µl) and on previously diagnosed HIV-related conditions. |
| Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 24 | From Baseline to Week 24 | A blood sample was drawn for particiapants with confirmed VF \>=400 c/mL. 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 viral mutations defined by the International Acquired Immunodeficiency Syndrome Society-United States of America guidelines present at the time of failure were tabulated by drug class. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. |
| Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 48 | From Baseline to Week 48 | A blood sample was drawn for particiapants with confirmed VF \>=400 c/mL. 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 viral mutations defined by the International Acquired Immunodeficiency Syndrome Society-United States of America guidelines present at the time of failure were tabulated by drug class. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. |
| Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 24 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir | From Baseline to Week 24 | 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. |
| Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 48 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir | From Baseline to Week 48 | 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. |
| Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | From Baseline to Week 24 | The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 is a descriptive terminology that can be utilized for AE reporting. A grading (severity) scale is provided for each AE. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1, mild AE; Grade 2, moderate AE; Grade 3, severe AE; Grade 4, life-threatening or disabling AE; Grade 5, death related to the AE. |
| Change From Baseline in Cholesterol/HDL Ratio at Week 24 | Baseline and Week 24 | A Fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 24 value minus the Baseline value. |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
Participants (PAR) were recruited from 44 centers in the United States, including Puerto Rico. ATV, atazanavir; RTV, ritonavir; TDF, tenofovir; FTC, emtricitrabine; QD, once daily; HIV-RNA, human immunodeficiency virus-ribonucleic acid; c, copies; ml, milliliters; ART, antiretroviral; mg, milligrams, ABC/3TC, abacavir sulfate/lamivudine.
Pre-assignment details
HLA-B\*5701-negative PAR receiving an ATV/RTV + TDF/FTC regimen QD who are virologically suppressed (plasma HIV-1 RNA \<75 c/mL) and met all eligibility requirements were randomized 2:1 to receive an ART regimen of ATV 400 mg QD + ABC/3TC 600 mg/300 mg QD (simplification arm) or ATV/RTV 300 mg/100 mg QD + TDF/FTC 300 mg/200 mg QD (continuation arm).
Participants by arm
| Arm | Count |
|---|---|
| ABC/3TC + ATV Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks | 199 |
| TDF/FTC + ATV/RTV Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks | 97 |
| Total | 296 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 8 | 2 |
| Overall Study | Investigator Discretion | 2 | 0 |
| Overall Study | Lack of Efficacy | 2 | 1 |
| Overall Study | Lost to Follow-up | 10 | 5 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 6 |
Baseline characteristics
| Characteristic | Total | ABC/3TC + ATV | TDF/FTC + ATV/RTV |
|---|---|---|---|
| Age Continuous | 42.6 Years STANDARD_DEVIATION 9.74 | 42.8 Years STANDARD_DEVIATION 9.54 | 42.3 Years STANDARD_DEVIATION 10.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 77 Participants | 51 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 219 Participants | 148 Participants | 71 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Median Baseline CD4+ Cell Count | 491.5 cells per cubic millimeter | 492.0 cells per cubic millimeter | 480.0 cells per cubic millimeter |
| Median Baseline HIV-1 RNA Level | 1.591 log10 copies/mL | 1.591 log10 copies/mL | 1.591 log10 copies/mL |
| Number of participants with the indicated Baseline CD4+ Cell Count CD4+ cells >=200 | 276 participants | 185 participants | 91 participants |
| Number of participants with the indicated Baseline CD4+ Cell Count CD4+ cells <50 | 0 participants | 0 participants | 0 participants |
| Number of participants with the indicated Baseline CD4+ Cell Count CD4+ cells 50-<200 | 20 participants | 14 participants | 6 participants |
| Number of participants with the indicated Baseline Hepatitis B (HB) Status Non-reactive | 296 participants | 199 participants | 97 participants |
| Number of participants with the indicated Baseline Hepatitis B (HB) Status Reactive | 0 participants | 0 participants | 0 participants |
| Number of participants with the indicated Baseline Hepatitis C (HC) Status Non-reactive | 270 participants | 181 participants | 89 participants |
| Number of participants with the indicated Baseline Hepatitis C (HC) Status Reactive | 26 participants | 18 participants | 8 participants |
| Number of participants with the indicated baseline HIV-RNA level HIV-1 RNA <50 | 285 participants | 192 participants | 93 participants |
| Number of participants with the indicated baseline HIV-RNA level HIV-1 RNA 50-<75 | 4 participants | 2 participants | 2 participants |
| Number of participants with the indicated baseline HIV-RNA level HIV-1 RNA >=75 | 7 participants | 5 participants | 2 participants |
| Number of participants with the indicated Center for Disease Control (CDC) Classification Class A: Asymptomatic/lymphadenopathy/acute HIV | 203 participants | 136 participants | 67 participants |
| Number of participants with the indicated Center for Disease Control (CDC) Classification Class B: Symptomatic, not AIDS | 39 participants | 26 participants | 13 participants |
| Number of participants with the indicated Center for Disease Control (CDC) Classification Class C: AIDS indicator conditions | 54 participants | 37 participants | 17 participants |
| Race/Ethnicity, Customized African American/African Heritage | 102 Participants | 65 Participants | 37 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 3 Participants | 3 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 5 Participants | 4 Participants | 1 Participants |
| Race/Ethnicity, Customized Mixed Race | 6 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White - Arabic/North African Heritage | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 175 Participants | 120 Participants | 55 Participants |
| Sex: Female, Male Female | 62 Participants | 44 Participants | 18 Participants |
| Sex: Female, Male Male | 234 Participants | 155 Participants | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 92 / 199 | 31 / 97 |
| serious Total, serious adverse events | 21 / 199 | 6 / 97 |
Outcome results
Primary
Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c)/Milliliter (mL) at the Week 24 Visit: TLOVR Analysis
The percentage of PAR with HIV-1 RNA virus \<50 c/mL determined from blood samples drawn at Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment. 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 the last visit.
Time frame: Week 24
Population: Intent-to-Treat (ITT)-Exposed Population: all participants exposed to at least one dose of study medication. The primary analysis method was time to loss of virologic response (TLOVR) for the proportion of participants HIV-1 RNA \<50 copies/mL at Week 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABC/3TC + ATV | Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c)/Milliliter (mL) at the Week 24 Visit: TLOVR Analysis | 86.9 percentage of participants |
| TDF/FTC + ATV/RTV | Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c)/Milliliter (mL) at the Week 24 Visit: TLOVR Analysis | 86.6 percentage of participants |
p-value: 0.93795% CI: [-7.97, 8.64]Cochran-Mantel-Haenszel
Secondary
Change From Baseline in CD4+ Cell Count at Week 24
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 24 value minus the Baseline value.
Time frame: Baseline and Week 24
Population: ITT-E Population. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 24 visit and had a CD4+ cell count obtained during that visit period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABC/3TC + ATV | Change From Baseline in CD4+ Cell Count at Week 24 | 47.7 cells per cubic millimeter (mm^3) | Standard Deviation 134.02 |
| TDF/FTC + ATV/RTV | Change From Baseline in CD4+ Cell Count at Week 24 | 8.3 cells per cubic millimeter (mm^3) | Standard Deviation 122.4 |
Secondary
Change From Baseline in CD4+ Cell Count at Week 48
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 48 value minus the Baseline value.
Time frame: Baseline and Week 48
Population: ITT-E Population. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 48 visit and had a CD4+ cell count obtained during that visit period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABC/3TC + ATV | Change From Baseline in CD4+ Cell Count at Week 48 | 95.8 cells per cubic millimeter (mm^3) | Standard Deviation 158.93 |
| TDF/FTC + ATV/RTV | Change From Baseline in CD4+ Cell Count at Week 48 | 57.2 cells per cubic millimeter (mm^3) | Standard Deviation 139.84 |
Secondary
Change From Baseline in Cholesterol/HDL Ratio at Week 24
A Fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 24 value minus the Baseline value.
Time frame: Baseline and Week 24
Population: Safety Population: all randomized participants, with the exception of those with documented evidence of not having consumed any Investigational Product. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 24 visit and had a measurement taken during that visit period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABC/3TC + ATV | Change From Baseline in Cholesterol/HDL Ratio at Week 24 | -0.20 ratio | Standard Deviation 0.57 |
| TDF/FTC + ATV/RTV | Change From Baseline in Cholesterol/HDL Ratio at Week 24 | -0.01 ratio | Standard Deviation 0.66 |
Secondary
Change From Baseline in Cholesterol/HDL Ratio at Week 48
A fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 48 value minus the Baseline value for each parameter.
Time frame: Baseline and Week 48
Population: Safety Population: all randomized participants, with the exception of those with documented evidence of not having consumed any Investigational Product. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 48 visit and had a measurement taken during that visit period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABC/3TC + ATV | Change From Baseline in Cholesterol/HDL Ratio at Week 48 | 0.00 ratio | Standard Deviation 0.97 |
| TDF/FTC + ATV/RTV | Change From Baseline in Cholesterol/HDL Ratio at Week 48 | 0.00 ratio | Standard Deviation 0.69 |
Secondary
Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 24
Triglycerides, total cholesterol, HDL cholesterol, and LDL cholesterol levels were measured at Week 24. A Fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 24 value minus the Baseline value for each parameter.
Time frame: Baseline and Week 24
Population: Safety Population: all randomized participants, with the exception of those with documented evidence of not having consumed any Investigational Product. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 24 visit and had a measurement taken during that visit period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABC/3TC + ATV | Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 24 | Triglycerides, n=170, 81 | -17.23 milligrams per deciliter (mg/dL) | Standard Deviation 62.29 |
| ABC/3TC + ATV | Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 24 | Total cholesterol, n=170, 81 | 4.49 milligrams per deciliter (mg/dL) | Standard Deviation 26.37 |
| ABC/3TC + ATV | Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 24 | HDL cholesterol, n=170, 81 | 4.50 milligrams per deciliter (mg/dL) | Standard Deviation 8.78 |
| ABC/3TC + ATV | Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 24 | LDL cholesterol (Calculation), n=166, 80 | 3.34 milligrams per deciliter (mg/dL) | Standard Deviation 22.48 |
| TDF/FTC + ATV/RTV | Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 24 | LDL cholesterol (Calculation), n=166, 80 | 0.94 milligrams per deciliter (mg/dL) | Standard Deviation 25.72 |
| TDF/FTC + ATV/RTV | Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 24 | Triglycerides, n=170, 81 | -4.35 milligrams per deciliter (mg/dL) | Standard Deviation 63 |
| TDF/FTC + ATV/RTV | Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 24 | HDL cholesterol, n=170, 81 | -0.20 milligrams per deciliter (mg/dL) | Standard Deviation 8.73 |
| TDF/FTC + ATV/RTV | Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 24 | Total cholesterol, n=170, 81 | 0.14 milligrams per deciliter (mg/dL) | Standard Deviation 26.24 |
Secondary
Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 48
Triglycerides, total cholesterol, HDL cholesterol, and LDL cholesterol levels were measured or calculated at Week 48. A fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 48 value minus the Baseline value for each parameter.
Time frame: Baseline and Week 48
Population: Safety Population: all randomized participants, with the exception of those with documented evidence of not having consumed any Investigational Product. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 48 visit and had a measurement taken during that visit period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABC/3TC + ATV | Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 48 | Triglycerides, n=152, 76 | -9.28 milligrams per deciliter (mg/dL) | Standard Deviation 65.39 |
| ABC/3TC + ATV | Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 48 | Total cholesterol, n=152, 76 | 7.62 milligrams per deciliter (mg/dL) | Standard Deviation 31.04 |
| ABC/3TC + ATV | Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 48 | HDL cholesterol, n=152, 76 | 3.11 milligrams per deciliter (mg/dL) | Standard Deviation 9.33 |
| ABC/3TC + ATV | Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 48 | LDL cholesterol (Calculation), n=148, 71 | 5.28 milligrams per deciliter (mg/dL) | Standard Deviation 26.35 |
| TDF/FTC + ATV/RTV | Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 48 | LDL cholesterol (Calculation), n=148, 71 | -0.62 milligrams per deciliter (mg/dL) | Standard Deviation 28.21 |
| TDF/FTC + ATV/RTV | Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 48 | Triglycerides, n=152, 76 | 7.71 milligrams per deciliter (mg/dL) | Standard Deviation 91 |
| TDF/FTC + ATV/RTV | Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 48 | HDL cholesterol, n=152, 76 | 0.53 milligrams per deciliter (mg/dL) | Standard Deviation 9.58 |
| TDF/FTC + ATV/RTV | Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 48 | Total cholesterol, n=152, 76 | 0.62 milligrams per deciliter (mg/dL) | Standard Deviation 29.9 |
Secondary
Change From Baseline in HIV-1 RNA at Week 24
Change from Baseline was calculated as the Week 24 value minus the Baseline value. Blood was drawn to analyze for plasma HIV viral load.
Time frame: Baseline and Week 24
Population: ITT-E Population. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 24 visit and had a viral load result obtained during that visit period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABC/3TC + ATV | Change From Baseline in HIV-1 RNA at Week 24 | 0.014 log10 copies/mL | Standard Deviation 0.271 |
| TDF/FTC + ATV/RTV | Change From Baseline in HIV-1 RNA at Week 24 | 0.008 log10 copies/mL | Standard Deviation 0.352 |
Secondary
Change From Baseline in HIV-1 RNA at Week 48
Change from Baseline was calculated as the Week 48 value minus the Baseline value. Blood was drawn to analyze for plasma HIV viral load.
Time frame: Baseline and Week 48
Population: ITT-E Population. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 48 visit and had a viral load result obtained during that visit period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABC/3TC + ATV | Change From Baseline in HIV-1 RNA at Week 48 | 0.071 log10 copies/mL | Standard Deviation 0.448 |
| TDF/FTC + ATV/RTV | Change From Baseline in HIV-1 RNA at Week 48 | -0.018 log10 copies/mL | Standard Deviation 0.198 |
Secondary
Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 24 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, 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.
Time frame: From Baseline to Week 24
Population: ITT-E Population. Only those participants who met the confirmed VF criteria with viral phenotype obtained at the time of virologic failure were assessed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC + ATV | Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 24 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir | HIV PAR with reduced abacavir susceptibility | 1 participants |
| ABC/3TC + ATV | Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 24 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir | HIV PAR with reduced lamivudine susceptibility | 1 participants |
| ABC/3TC + ATV | Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 24 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir | HIV PAR with reduced tenofovir susceptibility | 0 participants |
| ABC/3TC + ATV | Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 24 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir | HIV PAR with reduced emtricitabine susceptibility | 1 participants |
| ABC/3TC + ATV | Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 24 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir | HIV PAR with reduced atazanavir susceptibility | 1 participants |
| ABC/3TC + ATV | Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 24 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir | HIV PAR with reduced ritonavir susceptibility | 1 participants |
| TDF/FTC + ATV/RTV | Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 24 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir | HIV PAR with reduced atazanavir susceptibility | 0 participants |
| TDF/FTC + ATV/RTV | Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 24 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir | HIV PAR with reduced abacavir susceptibility | 0 participants |
| TDF/FTC + ATV/RTV | Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 24 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir | HIV PAR with reduced emtricitabine susceptibility | 0 participants |
| TDF/FTC + ATV/RTV | Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 24 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir | HIV PAR with reduced lamivudine susceptibility | 0 participants |
| TDF/FTC + ATV/RTV | Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 24 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir | HIV PAR with reduced ritonavir susceptibility | 0 participants |
| TDF/FTC + ATV/RTV | Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 24 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir | HIV PAR with reduced tenofovir susceptibility | 0 participants |
Secondary
Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 48 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, 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.
Time frame: From Baseline to Week 48
Population: ITT-E Population. Only those participants who met the confirmed VF criteria with viral phenotype obtained at the time of virologic failure were assessed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC + ATV | Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 48 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir | HIV PAR with reduced abacavir susceptibility | 1 participants |
| ABC/3TC + ATV | Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 48 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir | HIV PAR with reduced lamivudine susceptibility | 2 participants |
| ABC/3TC + ATV | Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 48 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir | HIV PAR with reduced tenofovir susceptibility | 0 participants |
| ABC/3TC + ATV | Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 48 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir | HIV PAR with reduced emtricitabine susceptibility | 2 participants |
| ABC/3TC + ATV | Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 48 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir | HIV PAR with reduced atazanavir susceptibility | 2 participants |
| ABC/3TC + ATV | Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 48 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir | HIV PAR with reduced ritonavir susceptibility | 2 participants |
| TDF/FTC + ATV/RTV | Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 48 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir | HIV PAR with reduced atazanavir susceptibility | 0 participants |
| TDF/FTC + ATV/RTV | Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 48 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir | HIV PAR with reduced abacavir susceptibility | 0 participants |
| TDF/FTC + ATV/RTV | Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 48 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir | HIV PAR with reduced emtricitabine susceptibility | 0 participants |
| TDF/FTC + ATV/RTV | Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 48 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir | HIV PAR with reduced lamivudine susceptibility | 0 participants |
| TDF/FTC + ATV/RTV | Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 48 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir | HIV PAR with reduced ritonavir susceptibility | 0 participants |
| TDF/FTC + ATV/RTV | Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 48 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir | HIV PAR with reduced tenofovir susceptibility | 0 participants |
Secondary
Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 24
A blood sample was drawn for particiapants with confirmed VF \>=400 c/mL. 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 viral mutations defined by the International Acquired Immunodeficiency Syndrome Society-United States of America guidelines present at the time of failure were tabulated by drug class. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.
Time frame: From Baseline to Week 24
Population: ITT-E Population. Only those participants who met the confirmed VF criteria and had a viral genotype obtained at the time of VF were assessed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC + ATV | Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 24 | PAR with NRTI mutations | 1 participants |
| ABC/3TC + ATV | Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 24 | PAR with major PI mutations | 1 participants |
| ABC/3TC + ATV | Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 24 | PAR with NNRTI mutations | 1 participants |
| ABC/3TC + ATV | Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 24 | PAR with minor PI mutations | 2 participants |
| ABC/3TC + ATV | Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 24 | PAR with treatment-emergent mutations | 2 participants |
| TDF/FTC + ATV/RTV | Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 24 | PAR with minor PI mutations | 1 participants |
| TDF/FTC + ATV/RTV | Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 24 | PAR with treatment-emergent mutations | 1 participants |
| TDF/FTC + ATV/RTV | Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 24 | PAR with NRTI mutations | 0 participants |
| TDF/FTC + ATV/RTV | Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 24 | PAR with NNRTI mutations | 0 participants |
| TDF/FTC + ATV/RTV | Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 24 | PAR with major PI mutations | 0 participants |
Secondary
Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 48
A blood sample was drawn for particiapants with confirmed VF \>=400 c/mL. 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 viral mutations defined by the International Acquired Immunodeficiency Syndrome Society-United States of America guidelines present at the time of failure were tabulated by drug class. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.
Time frame: From Baseline to Week 48
Population: ITT-E Population. Only those participants who met the confirmed VF criteria and had a viral genotype obtained at the time of VF were assessed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC + ATV | Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 48 | PAR with NRTI mutations | 2 participants |
| ABC/3TC + ATV | Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 48 | PAR with major PI mutations | 2 participants |
| ABC/3TC + ATV | Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 48 | PAR with major NNRTI mutations | 1 participants |
| ABC/3TC + ATV | Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 48 | PAR with minor PI mutations | 4 participants |
| ABC/3TC + ATV | Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 48 | PAR with treatment-emergent mutations | 4 participants |
| TDF/FTC + ATV/RTV | Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 48 | PAR with minor PI mutations | 1 participants |
| TDF/FTC + ATV/RTV | Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 48 | PAR with treatment-emergent mutations | 1 participants |
| TDF/FTC + ATV/RTV | Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 48 | PAR with NRTI mutations | 0 participants |
| TDF/FTC + ATV/RTV | Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 48 | PAR with major NNRTI mutations | 0 participants |
| TDF/FTC + ATV/RTV | Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 48 | PAR with major PI mutations | 0 participants |
Secondary
Number of Participants Who Experienced Death and/or Disease Progression
Death and clinical disease progression (as per CDC classification) were assessed from Baseline through Week 48. Disease progression is defined as progression from CDC Class A to B, Class A to C, or from Class B to C. AIDS CDC classifications are: Class A, Asymptomatic/lymphadenopathy/acute HIV; Class B, Symptomatic, not AIDS; Class C, AIDS indicator conditions. The CDC categorization of HIV/AIDS is based on the lowest documented CD4 cell count (Class A, \>=500 cells per microliter \[µl\]; Class B, 200-499 cells/µl; Class C, \<200 cells/µl) and on previously diagnosed HIV-related conditions.
Time frame: From Baseline to Week 48
Population: ITT-E Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABC/3TC + ATV | Number of Participants Who Experienced Death and/or Disease Progression | 0 participants |
| TDF/FTC + ATV/RTV | Number of Participants Who Experienced Death and/or Disease Progression | 0 participants |
Secondary
Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 24
The number of participants that failed to remain virologically suppressed through 24 weeks on treatment was assessed. Viral failure is defined per protocol as confirmed HIV-1 RNA \>=400 c/mL.
Time frame: From Baseline to Week 24
Population: ITT-E Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABC/3TC + ATV | Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 24 | 2 participants |
| TDF/FTC + ATV/RTV | Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 24 | 1 participants |
Secondary
Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 48
The number of participants that failed to remain virologically suppressed from baseline through 48 weeks on treatment was assessed. Viral failure is defined per protocol as confirmed HIV-1 RNA \>=400 c/mL.
Time frame: From Baseline to Week 48
Population: ITT-E Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABC/3TC + ATV | Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 48 | 4 participants |
| TDF/FTC + ATV/RTV | Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 48 | 1 participants |
Secondary
Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group
The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 is a descriptive terminology that can be utilized for AE reporting. A grading (severity) scale is provided for each AE. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1, mild AE; Grade 2, moderate AE; Grade 3, severe AE; Grade 4, life-threatening or disabling AE; Grade 5, death related to the AE.
Time frame: From Baseline to Week 48
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC + ATV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Depression | 6 participants |
| ABC/3TC + ATV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Insomnia | 6 participants |
| ABC/3TC + ATV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Diarrhoea | 7 participants |
| ABC/3TC + ATV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Muscle strain | 3 participants |
| ABC/3TC + ATV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Back pain | 4 participants |
| ABC/3TC + ATV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Rash | 6 participants |
| ABC/3TC + ATV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Upper respiratory tract infection | 11 participants |
| ABC/3TC + ATV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Sinusitis | 2 participants |
| ABC/3TC + ATV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Bronchitis | 4 participants |
| ABC/3TC + ATV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Muscle spasms | 2 participants |
| ABC/3TC + ATV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Any Event | 90 participants |
| TDF/FTC + ATV/RTV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Muscle spasms | 3 participants |
| TDF/FTC + ATV/RTV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Any Event | 44 participants |
| TDF/FTC + ATV/RTV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Upper respiratory tract infection | 7 participants |
| TDF/FTC + ATV/RTV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Diarrhoea | 4 participants |
| TDF/FTC + ATV/RTV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Depression | 3 participants |
| TDF/FTC + ATV/RTV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Back pain | 3 participants |
| TDF/FTC + ATV/RTV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Bronchitis | 3 participants |
| TDF/FTC + ATV/RTV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Insomnia | 0 participants |
| TDF/FTC + ATV/RTV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Muscle strain | 3 participants |
| TDF/FTC + ATV/RTV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Rash | 0 participants |
| TDF/FTC + ATV/RTV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Sinusitis | 4 participants |
Secondary
Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group
The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 is a descriptive terminology that can be utilized for AE reporting. A grading (severity) scale is provided for each AE. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1, mild AE; Grade 2, moderate AE; Grade 3, severe AE; Grade 4, life-threatening or disabling AE; Grade 5, death related to the AE.
Time frame: From Baseline to Week 24
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC + ATV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Muscle spasms | 1 participants |
| ABC/3TC + ATV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Upper respiratory tract infection | 7 participants |
| ABC/3TC + ATV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Diarrhoea | 5 participants |
| ABC/3TC + ATV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Bronchitis | 4 participants |
| ABC/3TC + ATV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Rash | 6 participants |
| ABC/3TC + ATV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Muscle strain | 2 participants |
| ABC/3TC + ATV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Sinusitis | 1 participants |
| TDF/FTC + ATV/RTV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Muscle spasms | 3 participants |
| TDF/FTC + ATV/RTV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Rash | 0 participants |
| TDF/FTC + ATV/RTV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Upper respiratory tract infection | 6 participants |
| TDF/FTC + ATV/RTV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Sinusitis | 3 participants |
| TDF/FTC + ATV/RTV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Diarrhoea | 3 participants |
| TDF/FTC + ATV/RTV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Muscle strain | 3 participants |
| TDF/FTC + ATV/RTV | Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group | Bronchitis | 3 participants |
Secondary
Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: Observed, MD=F, and SNAPSHOT Analyses
The percentage of PAR with HIV-1 RNA virus \<400 c/mL determined from blood samples drawn at Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods.
Time frame: Week 24
Population: ITT-E Population. Analysis methods: (1) Observed: all observed data; (2) MD=F: PAR with missing data/data collected after study medication discontinuation (DC) were failures; (3) SNAPSHOT: PAR with missing data at Week 24/data collected after study medication DC/viral load \>=400 c/mL were failures.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC + ATV | Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: Observed, MD=F, and SNAPSHOT Analyses | Observed, n=181, 89 | 98.9 percentage of participants |
| ABC/3TC + ATV | Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: Observed, MD=F, and SNAPSHOT Analyses | M/D=F, n=199, 97 | 88.9 percentage of participants |
| ABC/3TC + ATV | Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: Observed, MD=F, and SNAPSHOT Analyses | SNAPSHOT, n=199, 97 | 89.4 percentage of participants |
| TDF/FTC + ATV/RTV | Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: Observed, MD=F, and SNAPSHOT Analyses | Observed, n=181, 89 | 98.9 percentage of participants |
| TDF/FTC + ATV/RTV | Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: Observed, MD=F, and SNAPSHOT Analyses | M/D=F, n=199, 97 | 88.7 percentage of participants |
| TDF/FTC + ATV/RTV | Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: Observed, MD=F, and SNAPSHOT Analyses | SNAPSHOT, n=199, 97 | 89.7 percentage of participants |
Secondary
Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: TLOVR Analysis
The percentage of PAR with HIV-1 RNA virus \<400 c/mL determined from blood samples drawn at Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment. Per TLOVR algorithm, responders were PAR with confirmed viral load \<400 c/mL who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA \<400 c/mL, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 400 c/mL, or had an unconfirmed HIV RNA of at least 400 c/mL at the last visit.
Time frame: Week 24
Population: ITT-E Population. The primary analysis method was time to loss of virologic response (TLOVR) for the proportion of participants HIV-1 RNA \<400 copies/mL at Week 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABC/3TC + ATV | Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: TLOVR Analysis | 88.4 percentage of participants |
| TDF/FTC + ATV/RTV | Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: TLOVR Analysis | 86.6 percentage of participants |
Secondary
Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: Observed, MD=F, and SNAPSHOT Analyses
The percentage of PAR with HIV-1 RNA virus \<400 c/mL determined from blood samples drawn at Week 48 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods.
Time frame: Week 48
Population: ITT-E Population. Analysis methods: (1) Observed: all observed data; (2) MD=F: PAR with missing data/data collected after study medication discontinuation (DC) were failures; (3) SNAPSHOT: PAR with missing data at Week 24/data collected after study medication DC/viral load \>=400 c/mL were failures.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC + ATV | Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: Observed, MD=F, and SNAPSHOT Analyses | Observed, n=169, 82 | 96 Percentage of participants |
| ABC/3TC + ATV | Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: Observed, MD=F, and SNAPSHOT Analyses | M/D=F, n=199, 97 | 81 Percentage of participants |
| ABC/3TC + ATV | Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: Observed, MD=F, and SNAPSHOT Analyses | SNAPSHOT, n=199, 97 | 82 Percentage of participants |
| TDF/FTC + ATV/RTV | Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: Observed, MD=F, and SNAPSHOT Analyses | Observed, n=169, 82 | 100 Percentage of participants |
| TDF/FTC + ATV/RTV | Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: Observed, MD=F, and SNAPSHOT Analyses | M/D=F, n=199, 97 | 82 Percentage of participants |
| TDF/FTC + ATV/RTV | Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: Observed, MD=F, and SNAPSHOT Analyses | SNAPSHOT, n=199, 97 | 85 Percentage of participants |
Secondary
Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: TLOVR Analysis
The percentage of PAR with HIV-1 RNA virus \<400 c/mL determined from blood samples drawn at Week 48 was tabulated by treatment arm with stratification by initial antiretroviral treatment. Per TLOVR algorithm, responders were PAR with confirmed viral load \<400 c/mL who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA \<400 c/mL, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 400 c/mL, or had an unconfirmed HIV RNA of at least 400 c/mL at the last visit.
Time frame: Week 48
Population: ITT-E Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABC/3TC + ATV | Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: TLOVR Analysis | 81 Percentage of participants |
| TDF/FTC + ATV/RTV | Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: TLOVR Analysis | 84 Percentage of participants |
Secondary
Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 24 Visit: Observed, M/D=F, and SNAPSHOT Analyses
The percentage of PAR with HIV-1 RNA virus \<50 c/mL determined from blood samples drawn through Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods.
Time frame: Week 24
Population: ITT-E Population. Analysis methods: (1) Observed: all observed data; (2) missing or discontinuation equals failure (M/D=F): PAR with missing data/data collected after study medication discontinuation (DC) were failures; (3) SNAPSHOT: PAR with missing data at Week 24/data collected after study medication DC/viral load \>=50 c/mL were failures.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC + ATV | Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 24 Visit: Observed, M/D=F, and SNAPSHOT Analyses | SNAPSHOT, n=199, 97 | 84.9 percentage of participants |
| ABC/3TC + ATV | Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 24 Visit: Observed, M/D=F, and SNAPSHOT Analyses | Observed, n=181, 89 | 94.5 percentage of participants |
| ABC/3TC + ATV | Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 24 Visit: Observed, M/D=F, and SNAPSHOT Analyses | M/D=F, n=199, 97 | 84.9 percentage of participants |
| TDF/FTC + ATV/RTV | Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 24 Visit: Observed, M/D=F, and SNAPSHOT Analyses | Observed, n=181, 89 | 97.7 percentage of participants |
| TDF/FTC + ATV/RTV | Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 24 Visit: Observed, M/D=F, and SNAPSHOT Analyses | M/D=F, n=199, 97 | 87.6 percentage of participants |
| TDF/FTC + ATV/RTV | Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 24 Visit: Observed, M/D=F, and SNAPSHOT Analyses | SNAPSHOT, n=199, 97 | 88.7 percentage of participants |
Secondary
Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 48 Visit: TLOVR, Observed, M/D=F, and SNAPSHOT Analyses
The percentage of PAR with HIV-1 RNA virus \<50 c/mL determined from blood samples drawn at Week 48 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods.
Time frame: Week 48
Population: ITT-E Population. Analysis methods: (1) Observed: all observed data; (2) missing or discontinuation equals failure (M/D=F): PAR with missing data/data collected after study medication discontinuation (DC) were failures; (3) SNAPSHOT: PAR with missing data at Week 24/data collected after study medication DC/viral load \>=50 c/mL were failures.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABC/3TC + ATV | Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 48 Visit: TLOVR, Observed, M/D=F, and SNAPSHOT Analyses | TLOVR, n=199, 97 | 76.4 Percentage of participants |
| ABC/3TC + ATV | Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 48 Visit: TLOVR, Observed, M/D=F, and SNAPSHOT Analyses | Observed, n=169, 82 | 91.1 Percentage of participants |
| ABC/3TC + ATV | Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 48 Visit: TLOVR, Observed, M/D=F, and SNAPSHOT Analyses | M/D=F, n=199, 97 | 76.9 Percentage of participants |
| ABC/3TC + ATV | Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 48 Visit: TLOVR, Observed, M/D=F, and SNAPSHOT Analyses | SNAPSHOT, n=199, 97 | 77.4 Percentage of participants |
| TDF/FTC + ATV/RTV | Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 48 Visit: TLOVR, Observed, M/D=F, and SNAPSHOT Analyses | SNAPSHOT, n=199, 97 | 81.4 Percentage of participants |
| TDF/FTC + ATV/RTV | Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 48 Visit: TLOVR, Observed, M/D=F, and SNAPSHOT Analyses | TLOVR, n=199, 97 | 79.4 Percentage of participants |
| TDF/FTC + ATV/RTV | Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 48 Visit: TLOVR, Observed, M/D=F, and SNAPSHOT Analyses | M/D=F, n=199, 97 | 79.4 Percentage of participants |
| TDF/FTC + ATV/RTV | Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 48 Visit: TLOVR, Observed, M/D=F, and SNAPSHOT Analyses | Observed, n=169, 82 | 96.3 Percentage of participants |