Time-weighted Average Change From Baseline Through Week 48 (DAVG48) in Plasma HIV-1 RNA
DAVG48 was defined as the time-weighted average between the first postbaseline value through the last value up to Week 48 minus the baseline value. DAVG48 was calculated using the trapezoidal rule with all available postbaseline data minus the baseline value.
Data for participants who discontinued the double-blind phase of the study early were included up until the point of discontinuation from the study (ie, missing data were not imputed).
Change From Baseline to Week 24 in HIV-1 RNA
Change From Baseline to Week 48 in HIV-1 RNA
Change From Baseline to Week 96 in HIV-1 RNA
Change From Baseline to Week 144 in HIV-1 RNA
Change From Baseline to Week 192 in HIV-1 RNA
Change From Baseline to Week 240 in HIV-1 RNA
Change From Baseline to Week 288 in HIV-1 RNA
Change From Baseline to Week 336 in HIV-1 RNA
No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.
Change From Baseline to Week 24 in Cluster Determinant 4 (CD4) Count
Change From Baseline to Week 48 in CD4 Count
Change From Baseline to Week 96 in CD4 Count
Change From Baseline to Week 144 in CD4 Count
Change From Baseline to Week 192 in CD4 Count
Change From Baseline to Week 240 in CD4 Count
Change From Baseline to Week 288 in CD4 Count
Change From Baseline to Week 336 in CD4 Count
No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.
Change From Baseline to Week 24 in CD4 Percentage
CD4 percentage is the percentage of total lymphocytes that are CD4 cells.
Change From Baseline to Week 48 in CD4 Percentage
CD4 percentage is the percentage of total lymphocytes that are CD4 cells.
Change From Baseline to Week 96 in CD4 Percentage
CD4 percentage is the percentage of total lymphocytes that are CD4 cells.
Change From Baseline to Week 144 in CD4 Percentage
CD4 percentage is the percentage of total lymphocytes that are CD4 cells.
Change From Baseline to Week 192 in CD4 Percentage
CD4 percentage is the percentage of total lymphocytes that are CD4 cells.
Change From Baseline to Week 240 in CD4 Percentage
CD4 percentage is the percentage of total lymphocytes that are CD4 cells.
Change From Baseline to Week 288 in CD4 Percentage
CD4 percentage is the percentage of total lymphocytes that are CD4 cells.
Change From Baseline to Week 336 in CD4 Percentage
No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.
Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 24
Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 48
Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 96
Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 144
Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 192
Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 240
Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0log 10 Copies/mL From Baseline to Week 288
Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 336
No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 24
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 192
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 240
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 288
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 336
No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 240
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 288
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 336
No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.
Percentage of Participants With Virologic Failure Through Week 48
Virologic failure was defined as either nonresponse or viral rebound.
Nonresponse (failure to achieve response). Response was defined as either
A ≥ 0.5 log10 copies/mL decrease in HIV-1 RNA from baseline at 2 consecutive visits, or
HIV-1 RNA < 400 copies/mL at 2 consecutive visits.
Viral rebound was defined as either
Participants who achieved a ≥ 0.5 log10 copies/mL decrease from baseline in plasma HIV-1 RNA at 2 consecutive visits, who then subsequently achieved plasma HIV-1 RNA values ≥ 1.0 log10 copies/mL above their on-study nadir (lowest value) and/or plasma HIV-1 RNA values ≥ the baseline value at 2 consecutive visits, or
Participants who achieved plasma HIV-1 RNA levels of < 400 copies/mL at 2 consecutive visits, and then subsequently had plasma HIV-1 RNA levels > 1000 copies/mL at 2 consecutive visits.
The virologic failure rate was estimated from Kaplan-Meier product limit method by including all HIV-1 RNA data collected during the double-blind phase.