| Primary | Time-weighted Average Change From Baseline Through Week 24 (DAVG24) in Plasma HIV-1 RNA | DAVG24 was defined as the time-weighted average between the first postbaseline value through the last value up to Week 24 minus the baseline value. DAVG24 was calculated using the trapezoidal rule with all available postbaseline data minus the baseline value. Data for participants who discontinued the randomized (double-blind) phase of the study early were included up until the point of study discontinuation (missing data not imputed). | Intent-to-treat (ITT) Analysis Set: participants who were randomized and received at least 1 dose of study drug, with baseline HIV-1 RNA ≥ 1000 copies/mL and who had no major eligibility criteria violations. | Posted | | Median | Inter-Quartile Range | log10 copies/mL | | Baseline to 24 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included. | | OG001 | Placebo | Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-1.580(-2.15 to -0.27)
- OG001-1.549(-2.36 to -0.34)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Null hypothesis: Time-weighted average changes from baseline through Week 24 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Time-weighted average changes from baseline through Week 24 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are different (two-sided). | Van Elteren test | P-value is from a Van Elteren test stratified by baseline genotypic sensitivity score (GSS) (without tenofovir DF) <= or > median (median GSS is 2). | 0.55 | No adjustments for multiple comparisons were made. | | | | | | 95 | | | | | | No | |
|
| Secondary | 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). | | Posted | | Median | Inter-Quartile Range | log10 copies/mL | | Baseline to 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included. | | OG001 | Placebo | Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included. |
| |
| Secondary | Change From Baseline to Week 24 in HIV-1 RNA | | ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the last observation carried forward (LOCF) method (includes the participant's last available postbaseline value for missing data). The Placebo/TDF groups were analyzed using the missing = excluded method (participants with missing data were excluded from the analysis). | Posted | | Median | Inter-Quartile Range | log10 copies/mL | | Baseline to 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included. | | OG001 | Placebo | Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included. | | OG002 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
|
| Secondary | Change From Baseline to Week 48 in HIV-1 RNA | | ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the LOCF method. The Placebo/TDF groups were analyzed using the missing = excluded method. | Posted | | Median | Inter-Quartile Range | log10 copies/mL | | Baseline to 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included. | | OG001 | Placebo | Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included. | | OG002 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
|
| Secondary | Change From Baseline to Week 96 in HIV-1 RNA | | ITT Analysis Set, missing = excluded method | Posted | | Median | Inter-Quartile Range | log10 copies/mL | | Baseline to 96 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
| |
| Secondary | Change From Baseline to Week 144 in HIV-1 RNA | | ITT Analysis Set, missing = excluded method | Posted | | Median | Inter-Quartile Range | log10 copies/mL | | Baseline to 144 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
| |
| Secondary | Change From Baseline to Week 192 in HIV-1 RNA | | ITT Analysis Set, missing = excluded method | Posted | | Median | Inter-Quartile Range | log10 copies/mL | | Baseline to 192 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
| |
| Secondary | Change From Baseline to Week 240 in HIV-1 RNA | | ITT Analysis Set, missing = excluded method | Posted | | Median | Inter-Quartile Range | log10 copies/mL | | Baseline to 240 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
| |
| Secondary | Change From Baseline to Week 288 in HIV-1 RNA | | ITT Analysis Set, missing = excluded method | Posted | | Median | Inter-Quartile Range | log10 copies/mL | | Baseline to 288 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
| |
| Secondary | 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. | ITT Analysis Set, missing = excluded method | Posted | | | | | | Baseline to 336 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
|
| Secondary | Change From Baseline to Week 24 in Cluster Determinant 4 (CD4) Count | | ITT Analysis Set, missing = excluded method | Posted | | Median | Inter-Quartile Range | cells/mm3 | | Baseline to 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included. | | OG001 | Placebo | Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included. | | OG002 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
|
| Secondary | Change From Baseline to Week 48 in CD4 Count | | ITT Analysis Set, missing = excluded method | Posted | | Median | Inter-Quartile Range | cells/mm3 | | Baseline to 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included. | | OG001 | Placebo | Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included. | | OG002 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
|
| Secondary | Change From Baseline to Week 96 in CD4 Count | | ITT Analysis Set, missing = excluded method | Posted | | Median | Inter-Quartile Range | cells/mm3 | | Baseline to 96 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
| |
| Secondary | Change From Baseline to Week 144 in CD4 Count | | ITT Analysis Set, missing = excluded method | Posted | | Median | Inter-Quartile Range | cells/mm^3 | | Baseline to 144 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
| |
| Secondary | Change From Baseline to Week 192 in CD4 Count | | ITT Analysis Set, missing = excluded method | Posted | | Median | Inter-Quartile Range | cells/mm^3 | | Baseline to 192 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
| |
| Secondary | Change From Baseline to Week 240 in CD4 Count | | ITT Analysis Set, missing = excluded method | Posted | | Median | Inter-Quartile Range | cells/mm^3 | | Baseline to 240 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
| |
| Secondary | Change From Baseline to Week 288 in CD4 Count | | ITT Analysis Set, missing = excluded method | Posted | | Median | Inter-Quartile Range | cells/mm^3 | | Baseline to 288 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
| |
| Secondary | 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. | ITT Analysis Set, missing = excluded method | Posted | | | | | | Baseline to 336 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
|
| Secondary | Change From Baseline to Week 24 in CD4 Percentage | CD4 percentage is the percentage of total lymphocytes that are CD4 cells. | ITT Analysis Set, missing = excluded method | Posted | | Median | Inter-Quartile Range | Percentage of CD4 lymphocytes | | Baseline to 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included. | | OG001 | Placebo | Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included. | | OG002 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
|
| Secondary | Change From Baseline to Week 48 in CD4 Percentage | CD4 percentage is the percentage of total lymphocytes that are CD4 cells. | ITT Analysis Set, missing = excluded method | Posted | | Median | Inter-Quartile Range | Percentage of CD4 lymphocytes | | Baseline to 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included. | | OG001 | Placebo | Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included. | | OG002 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
|
| Secondary | Change From Baseline to Week 96 in CD4 Percentage | CD4 percentage is the percentage of total lymphocytes that are CD4 cells. | ITT Analysis Set, missing = excluded method | Posted | | Median | Inter-Quartile Range | Percentage of CD4 lymphocytes | | Baseline to 96 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
|
| Secondary | Change From Baseline to Week 144 in CD4 Percentage | CD4 percentage is the percentage of total lymphocytes that are CD4 cells. | ITT Analysis Set, missing = excluded method | Posted | | Median | Inter-Quartile Range | Percentage of CD4 lymphocytes | | Baseline to 144 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
|
| Secondary | Change From Baseline to Week 192 in CD4 Percentage | CD4 percentage is the percentage of total lymphocytes that are CD4 cells. | ITT Analysis Set, missing = excluded method | Posted | | Median | Inter-Quartile Range | Percentage of CD4 lymphocytes | | Baseline to 192 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
|
| Secondary | Change From Baseline to Week 240 in CD4 Percentage | CD4 percentage is the percentage of total lymphocytes that are CD4 cells. | ITT Analysis Set, missing = excluded method | Posted | | Median | Inter-Quartile Range | Percentage of CD4 lymphocytes | | Baseline to 240 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
|
| Secondary | Change From Baseline to Week 288 in CD4 Percentage | CD4 percentage is the percentage of total lymphocytes that are CD4 cells. | ITT Analysis Set, missing = excluded method | Posted | | Median | Inter-Quartile Range | Percentage of CD4 lymphocytes | | Baseline to 288 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
|
| Secondary | 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. | ITT Analysis Set, missing = excluded method | Posted | | | | | | Baseline to 336 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
|
| Secondary | Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 24 | | ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the LOCF method. The Placebo/TDF groups were analyzed using the missing = excluded method. | Posted | | Number | | Percentage of participants | | Baseline to 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included. | | OG001 | Placebo | Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included. | | OG002 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
|
| Secondary | Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 48 | | ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the LOCF method. The Placebo/TDF groups were analyzed using the missing = excluded method. | Posted | | Number | | Percentage of participants | | Baseline to 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included. | | OG001 | Placebo | Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included. | | OG002 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
|
| Secondary | Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 96 | | ITT Analysis Set, missing = excluded method | Posted | | Number | | Percentage of participants | | Baseline to 96 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
| |
| Secondary | Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 144 | | ITT Analysis Set, missing = excluded method | Posted | | Number | | Percentage of participants | | Baseline to 144 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
| |
| Secondary | Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 192 | | ITT Analysis Set, missing = excluded method | Posted | | Number | | Percentage of participants | | Baseline to 192 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
| |
| Secondary | Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 240 | | ITT Analysis Set, missing = excluded method | Posted | | Number | | Percentage of participants | | Baseline to 240 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
| |
| Secondary | Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0log 10 Copies/mL From Baseline to Week 288 | | ITT Analysis Set, missing = excluded method | Posted | | Number | | Percentage of participants | | Baseline to 288 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
| |
| Secondary | 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. | ITT Analysis Set, missing = excluded method | Posted | | | | | | Baseline to 336 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
|
| Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 24 | | ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the missing = failure method in which participants with missing data were considered to have failed to achieve the endpoint. The Placebo/TDF groups were analyzed using the missing = excluded method. | Posted | | Number | | Percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included. | | OG001 | Placebo | Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included. | | OG002 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
|
| Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48 | | ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the missing = failure method. The Placebo/TDF groups were analyzed using the missing = excluded method. | Posted | | Number | | Percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included. | | OG001 | Placebo | Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included. | | OG002 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
|
| Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96 | | ITT Analysis Set, missing = excluded method | Posted | | Number | | Percentage of participants | | Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
| |
| Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144 | | ITT Analysis Set, missing = excluded method | Posted | | Number | | Percentage of participants | | Week 144 | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA >= 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
| |
| Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 192 | | ITT Analysis Set, missing = excluded method | Posted | | Number | | Percentage of participants | | Week 192 | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
| |
| Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 240 | | ITT Analysis Set, missing = excluded method | Posted | | Number | | Percentage of participants | | Week 240 | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
| |
| Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 288 | | ITT Analysis Set, missing = excluded method | Posted | | Number | | Percentage of participants | | Week 288 | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
| |
| Secondary | 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. | ITT Analysis Set, missing = excluded method | Posted | | | | | | Week 336 | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
|
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 | | ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the missing = failure method. The Placebo/TDF groups were analyzed using the missing = excluded method. | Posted | | Number | | Percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included. | | OG001 | Placebo | Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included. | | OG002 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
|
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 | | ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the missing = failure method. The Placebo/TDF groups were analyzed using the missing = excluded method. | Posted | | Number | | Percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included. | | OG001 | Placebo | Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included. | | OG002 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
|
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 | | ITT Analysis Set, missing = excluded method | Posted | | Number | | Percentage of participants | | Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
| |
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144 | | ITT Analysis Set, missing = excluded method | Posted | | Number | | Percentage of participants | | Week 144 | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
| |
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192 | | ITT Analysis Set, missing = excluded method | Posted | | Number | | Percentage of participants | | Week 192 | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
| |
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 240 | | ITT Analysis Set, missing = excluded method | Posted | | Number | | Percentage of participants | | Week 240 | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
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| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 288 | | ITT Analysis Set, missing = excluded method | Posted | | Number | | Percentage of participants | | Week 288 | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
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| Secondary | 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. | ITT Analysis Set, missing = excluded method | Posted | | | | | | Week 336 | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. | | OG001 | Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. | | OG002 | Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch. |
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| Secondary | Percentage of Participants With Virologic Failure Through Week 48 | Virologic failure was defined as either nonresponse or viral rebound. 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. | ITT Analysis Set. 1 participant without time to respond [6 days of treatment]) was excluded. Nonresponders were counted as failures at time 0. Rebounders were counted as failures on study day of the first of 2 assessments meeting criteria. Otherwise, they were censored at last double-blind HIV measurement. | Posted | | Number | | Kaplan-Meier percentage | | Up to 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. |
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