Percentage of participants who achieved HIV RNA <400 copies/mL at Week 16

Percentage of participants who achieved HIV RNA <400 copies/mL at Week 48

Percentage of participants who achieved HIV RNA <400 copies/mL at Week 156

The analysis population was based on a non-completer equals failure approach where missing values for participants who discontinued the study for any reason were considered treatment failures.

Participants who experienced virologic failure after Week 16 are counted also as treatment failures for the subsequent virologic efficacy analyses.

Percentage of participants who achieved HIV RNA <400 Copies/mL at Week 240

The analysis population was based on a non-completer equals failure approach where missing values for participants who discontinued the study for any reason were considered treatment failures.

Participants who experienced virologic failure after Week 16 are counted also as treatment failures for the subsequent virologic efficacy analyses.

Percentage of participants who achieved HIV RNA <50 copies/mL at Week 16

Percentage of participants who achieved HIV RNA <50 copies/mL at Week 48

Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.

Percentage of participants who achieved HIV RNA <50 copies/mL at Week 156

Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.

Percentage of participants who achieved HIV RNA <50 copies/mL at Week 240

Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.

For participants with confirmed HIV RNA levels <50 copies/mL on 2 consecutive visits, loss of virologic response is the occurrence of the first value >50 copies/mL or loss to follow-up; participants who never achieved HIV RNA <50 copies/mL on 2 consecutive visits are also considered as having loss of virologic response. Events are the numbers of participants with loss of virologic response versus the numbers of participants with no loss of virologic response (event-free).

Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.

Mean change from baseline at Week 16 in HIV RNA (log 10 copies/mL)

Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: Baseline carry-forward for all failures/discontinued due to lack of efficacy

Mean change from baseline at Week 48 in HIV RNA (log10 copies/mL)

Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: Baseline carry-forward for all failures/discontinued due to lack of efficacy

Mean change from baseline at Week 156 in HIV RNA (log10 copies/mL)

Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: Baseline carry-forward for all failures/discontinued due to lack of efficacy

Mean change from baseline at Week 240 in HIV RNA (log10 copies/mL)

Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: Baseline carry-forward for all failures/discontinued due to lack of efficacy

Participants with virologic failure after Week 16 = treatment failures

Mean change from baseline at Week 16 in CD4 cell count (cells/mm^3)

Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.

Mean change from baseline at Week 48 in CD4 cell count (cells/mm^3)

Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.

Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses.

Mean change from baseline at Week 156 in CD4 cell count (cells/mm^3)

Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.

Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses.

Mean change from baseline at Week 240 in CD4 cell count (cells/mm^3)

Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.

Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses.