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.

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.

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.

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.

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.

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.

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.

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.

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.

ITT-E Population

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.

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.

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.

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.

Change from Baseline was calculated as the Week 24 value minus the Baseline value. Blood was drawn to analyze for plasma HIV viral load.

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.

Change from Baseline was calculated as the Week 48 value minus the Baseline value. Blood was drawn to analyze for plasma HIV viral load.

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.

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.

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.

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.

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.

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.

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.

A Fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 24 value minus the Baseline value.

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.

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.

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.

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.

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.

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.

ITT-E Population

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.

ITT-E Population

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.

ITT-E Population

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.

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.

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.

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.

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.

ITT-E Population. Only those participants who met the confirmed VF criteria with viral phenotype obtained at the time of virologic failure were assessed.

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.

ITT-E Population. Only those participants who met the confirmed VF criteria with viral phenotype obtained at the time of virologic failure were assessed.

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.

Safety Population

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.

Safety Population