| Primary | Comparison of Virologic Response at Week 24 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Primary endpoint was the number of patients with a sustained virologic response through week 24 | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment | Posted | | Number | | participants | | week 24 | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine Immediate Release (NVP IR) | Nevirapine immediate release 200 mg tablets given twice daily | | OG001 | Nevirapine Extended Release (NVP XR) | Nevirapine extended release 400 mg tablets given once daily |
| | | Title | Denominators | Categories |
|---|
| Responder | | | | Non responder | | |
| | 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 |
|---|
| | Cochran's statistic | | | | Cochran's statistic | 1.0 | | | | 95 | -4.3 | 6.2 | | | Weighted treatment difference and corresponding variance were calculated based on Cochran's statistic. | Yes | Non-Inferiority or Equivalence | Non-inferiority of nevirapine XR to nevirapine IR was established if the lower bound of the confidence interval was greater than -12% | |
|
| Secondary | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | Endpoint was the number of patients with a sustained virologic response through week 2 | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment | Posted | | Number | | participants | | week 2 | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine Immediate Release (NVP IR) | Nevirapine immediate release 200 mg tablets given twice daily | | OG001 | Nevirapine Extended Release (NVP XR) | Nevirapine extended release 400 mg tablets given once daily |
| |
| Secondary | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | Endpoint was the number of patients with a sustained virologic response through week 4 | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment | Posted | | Number | | participants | | week 4 | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine Immediate Release (NVP IR) | Nevirapine immediate release 200 mg tablets given twice daily | | OG001 | Nevirapine Extended Release (NVP XR) | Nevirapine extended release 400 mg tablets given once daily |
| |
| Secondary | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | Endpoint was the number of patients with a sustained virologic response through week 8 | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment | Posted | | Number | | participants | | week 8 | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine Immediate Release (NVP IR) | Nevirapine immediate release 200 mg tablets given twice daily | | OG001 | Nevirapine Extended Release (NVP XR) | Nevirapine extended release 400 mg tablets given once daily |
| |
| Secondary | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | Endpoint was the number of patients with a sustained virologic response through week 12 | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment | Posted | | Number | | participants | | week 12 | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine Immediate Release (NVP IR) | Nevirapine immediate release 200 mg tablets given twice daily | | OG001 | Nevirapine Extended Release (NVP XR) | Nevirapine extended release 400 mg tablets given once daily |
| |
| Secondary | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population | Endpoint was the number of patients with a sustained virologic response through week 24 | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment | Posted | | Number | | participants | | week 24 | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine Immediate Release (NVP IR) | Nevirapine immediate release 200 mg tablets given twice daily | | OG001 | Nevirapine Extended Release (NVP XR) | Nevirapine extended release 400 mg tablets given once daily |
| |
| Secondary | Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment | Posted | | Number | | proportion of participants | | week 0 to 24 | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine Immediate Release (NVP IR) | Nevirapine immediate release 200 mg tablets given twice daily | | OG001 | Nevirapine Extended Release (NVP XR) | Nevirapine extended release 400 mg tablets given once daily |
| |
| Secondary | Summary of CD4 Count (Cells/Cubic Millimeter) at Baseline, Full Analysis Set Population | | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline. | Posted | | Mean | Standard Deviation | cells/cubic millimeter | | week 0 | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine Immediate Release (NVP IR) | Nevirapine immediate release 200 mg tablets given twice daily | | OG001 | Nevirapine Extended Release (NVP XR) | Nevirapine extended release 400 mg tablets given once daily |
| |
| Secondary | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 2, Observed Cases, Full Analysis Set Population | | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 2. | Posted | | Mean | Standard Deviation | cells/cubic millimeter | | baseline, week 2 | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine Immediate Release (NVP IR) | Nevirapine immediate release 200 mg tablets given twice daily | | OG001 | Nevirapine Extended Release (NVP XR) | Nevirapine extended release 400 mg tablets given once daily |
| |
| Secondary | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 4, Observed Cases, Full Analysis Set Population | | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 4. | Posted | | Mean | Standard Deviation | cells/cubic millimeter | | baseline, week 4 | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine Immediate Release (NVP IR) | Nevirapine immediate release 200 mg tablets given twice daily | | OG001 | Nevirapine Extended Release (NVP XR) | Nevirapine extended release 400 mg tablets given once daily |
| |
| Secondary | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 8, Observed Cases, Full Analysis Set Population | | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 8. | Posted | | Mean | Standard Deviation | cells/cubic millimeter | | baseline, week 8 | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine Immediate Release (NVP IR) | Nevirapine immediate release 200 mg tablets given twice daily | | OG001 | Nevirapine Extended Release (NVP XR) | Nevirapine extended release 400 mg tablets given once daily |
| |
| Secondary | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 12, Observed Cases, Full Analysis Set Population | | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 12. | Posted | | Mean | Standard Deviation | cells/cubic millimeter | | baseline, week 12 | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine Immediate Release (NVP IR) | Nevirapine immediate release 200 mg tablets given twice daily | | OG001 | Nevirapine Extended Release (NVP XR) | Nevirapine extended release 400 mg tablets given once daily |
| |
| Secondary | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 24, Observed Cases, Full Analysis Set Population | | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 24. | Posted | | Mean | Standard Deviation | cells/cubic millimeter | | baseline, week 24 | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine Immediate Release (NVP IR) | Nevirapine immediate release 200 mg tablets given twice daily | | OG001 | Nevirapine Extended Release (NVP XR) | Nevirapine extended release 400 mg tablets given once daily |
| |
| Secondary | Comparison of CD4 Count (Cells/Cubic Millimeter) Change From Baseline at Week 24, Observed Cases, Full Analysis Set Population | | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.The population was restricted to participants who had CD4 count at baseline and week 24. | Posted | | Least Squares Mean | Standard Error | cells/cubic millimeter | | baseline, week 24 | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine Immediate Release (NVP IR) | Nevirapine immediate release 200 mg tablets given twice daily | | OG001 | Nevirapine Extended Release (NVP XR) | Nevirapine extended release 400 mg tablets given once daily |
| |
| Secondary | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Endpoint was the number of patients with a sustained virologic response through week 48 | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants present at week 48. | Posted | | Number | | participants | | week 48 | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine (NVP) IR / NVP XR | Nevirapine IR during first 48 weeks then switched to NVP XR | | OG001 | Nevirapine IR After Week 48 | Patient remained on NVP IR after week 48 | | OG002 | Nevirapine XR After Week 48 | Patient remained on NVP XR after week 48 |
| |
| Secondary | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Endpoint was the number of patients with a sustained virologic response through week 60 | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 60. | Posted | | Number | | participants | | week 60 | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine (NVP) IR / NVP XR | Nevirapine IR during first 48 weeks then switched to NVP XR | | OG001 | Nevirapine IR After Week 48 | Patient remained on NVP IR after week 48 | | OG002 | Nevirapine XR After Week 48 | Patient remained on NVP XR after week 48 |
| |
| Secondary | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Endpoint was the number of patients with a sustained virologic response through week 72 | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 72. | Posted | | Number | | participants | | week 72 | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine (NVP) IR / NVP XR | Nevirapine IR during first 48 weeks then switched to NVP XR | | OG001 | Nevirapine IR After Week 48 | Patient remained on NVP IR after week 48 | | OG002 | Nevirapine XR After Week 48 | Patient remained on NVP XR after week 48 |
| |
| Secondary | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Endpoint was the number of patients with a sustained virologic response through week 84 | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 84. | Posted | | Number | | participants | | week 84 | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine (NVP) IR / NVP XR | Nevirapine IR during first 48 weeks then switched to NVP XR | | OG001 | Nevirapine IR After Week 48 | Patient remained on NVP IR after week 48 | | OG002 | Nevirapine XR After Week 48 | Patient remained on NVP XR after week 48 |
| |
| Secondary | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Endpoint was the number of patients with a sustained virologic response through week 96 | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 96. | Posted | | Number | | participants | | week 96 | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine (NVP) IR / NVP XR | Nevirapine IR during first 48 weeks then switched to NVP XR | | OG001 | Nevirapine IR After Week 48 | Patient remained on NVP IR after week 48 | | OG002 | Nevirapine XR After Week 48 | Patient remained on NVP XR after week 48 |
| |
| Secondary | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Endpoint was the number of patients with a sustained virologic response through week 108 | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 108. | Posted | | Number | | participants | | week 108 | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine (NVP) IR / NVP XR | Nevirapine IR during first 48 weeks then switched to NVP XR | | OG001 | Nevirapine IR After Week 48 | Patient remained on NVP IR after week 48 | | OG002 | Nevirapine XR After Week 48 | Patient remained on NVP XR after week 48 |
| |
| Secondary | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Endpoint was the number of patients with a sustained virologic response through week 120 | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 120. | Posted | | Number | | participants | | week 120 | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine (NVP) IR / NVP XR | Nevirapine IR during first 48 weeks then switched to NVP XR | | OG001 | Nevirapine IR After Week 48 | Patient remained on NVP IR after week 48 | | OG002 | Nevirapine XR After Week 48 | Patient remained on NVP XR after week 48 |
| |
| Secondary | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Endpoint was the number of patients with a sustained virologic response through week 132 | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 132. | Posted | | Number | | participants | | week 132 | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine (NVP) IR / NVP XR | Nevirapine IR during first 48 weeks then switched to NVP XR | | OG001 | Nevirapine IR After Week 48 | Patient remained on NVP IR after week 48 | | OG002 | Nevirapine XR After Week 48 | Patient remained on NVP XR after week 48 |
| |
| Secondary | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Endpoint was the number of patients with a sustained virologic response through week 144 | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 144. | Posted | | Number | | participants | | week 144 | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine (NVP) IR / NVP XR | Nevirapine IR during first 48 weeks then switched to NVP XR | | OG001 | Nevirapine IR After Week 48 | Patient remained on NVP IR after week 48 | | OG002 | Nevirapine XR After Week 48 | Patient remained on NVP XR after week 48 |
| |
| Secondary | Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Endpoint was the number of patients with a sustained virologic response at their last available visit | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at last visit (up to 144 weeks). | Posted | | Number | | participants | | last available visit, up to 144 weeks | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine (NVP) IR / NVP XR | Nevirapine IR during first 48 weeks then switched to NVP XR | | OG001 | Nevirapine IR After Week 48 | Patient remained on NVP IR after week 48 | | OG002 | Nevirapine XR After Week 48 | Patient remained on NVP XR after week 48 |
| |
| Secondary | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 48, Observed Cases, Full Analysis Set Population | | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 48. | Posted | | Mean | Standard Deviation | cells/cubic millimeter | | baseline, week 48 | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine (NVP) IR / NVP XR | Nevirapine IR during first 48 weeks then switched to NVP XR | | OG001 | Nevirapine IR After Week 48 | Patient remained on NVP IR after week 48 | | OG002 | Nevirapine XR After Week 48 | Patient remained on NVP XR after week 48 |
| |
| Secondary | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 60, Observed Cases, Full Analysis Set Population | | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 60. | Posted | | Mean | Standard Deviation | cells/cubic millimeter | | baseline, week 60 | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine (NVP) IR / NVP XR | Nevirapine IR during first 48 weeks then switched to NVP XR | | OG001 | Nevirapine IR After Week 48 | Patient remained on NVP IR after week 48 | | OG002 | Nevirapine XR After Week 48 | Patient remained on NVP XR after week 48 |
| |
| Secondary | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 72, Observed Cases, Full Analysis Set Population | | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 72. | Posted | | Mean | Standard Deviation | cells/cubic millimeter | | baseline, week 72 | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine (NVP) IR / NVP XR | Nevirapine IR during first 48 weeks then switched to NVP XR | | OG001 | Nevirapine IR After Week 48 | Patient remained on NVP IR after week 48 | | OG002 | Nevirapine XR After Week 48 | Patient remained on NVP XR after week 48 |
| |
| Secondary | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 84, Observed Cases, Full Analysis Set Population | | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 84. | Posted | | Mean | Standard Deviation | cells/cubic millimeter | | baseline, week 84 | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine (NVP) IR / NVP XR | Nevirapine IR during first 48 weeks then switched to NVP XR | | OG001 | Nevirapine IR After Week 48 | Patient remained on NVP IR after week 48 | | OG002 | Nevirapine XR After Week 48 | Patient remained on NVP XR after week 48 |
| |
| Secondary | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 96, Observed Cases, Full Analysis Set Population | | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 96. | Posted | | Mean | Standard Deviation | cells/cubic millimeter | | baseline, week 96 | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine (NVP) IR / NVP XR | Nevirapine IR during first 48 weeks then switched to NVP XR | | OG001 | Nevirapine IR After Week 48 | Patient remained on NVP IR after week 48 | | OG002 | Nevirapine XR After Week 48 | Patient remained on NVP XR after week 48 |
| |
| Secondary | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 108, Observed Cases, Full Analysis Set Population | | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 108. | Posted | | Mean | Standard Deviation | cells/cubic millimeter | | baseline, week 108 | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine (NVP) IR / NVP XR | Nevirapine IR during first 48 weeks then switched to NVP XR | | OG001 | Nevirapine IR After Week 48 | Patient remained on NVP IR after week 48 | | OG002 | Nevirapine XR After Week 48 | Patient remained on NVP XR after week 48 |
| |
| Secondary | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 120, Observed Cases, Full Analysis Set Population | | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 120. | Posted | | Mean | Standard Deviation | cells/cubic millimeter | | baseline, week 120 | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine (NVP) IR / NVP XR | Nevirapine IR during first 48 weeks then switched to NVP XR | | OG001 | Nevirapine IR After Week 48 | Patient remained on NVP IR after week 48 | | OG002 | Nevirapine XR After Week 48 | Patient remained on NVP XR after week 48 |
| |
| Secondary | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 132, Observed Cases, Full Analysis Set Population | | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 132. | Posted | | Mean | Standard Deviation | cells/cubic millimeter | | baseline, week 132 | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine (NVP) IR / NVP XR | Nevirapine IR during first 48 weeks then switched to NVP XR | | OG001 | Nevirapine IR After Week 48 | Patient remained on NVP IR after week 48 | | OG002 | Nevirapine XR After Week 48 | Patient remained on NVP XR after week 48 |
| |
| Secondary | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 144, Observed Cases, Full Analysis Set Population | | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 144. | Posted | | Mean | Standard Deviation | cells/cubic millimeter | | baseline, week 144 | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine (NVP) IR / NVP XR | Nevirapine IR during first 48 weeks then switched to NVP XR | | OG001 | Nevirapine IR After Week 48 | Patient remained on NVP IR after week 48 | | OG002 | Nevirapine XR After Week 48 | Patient remained on NVP XR after week 48 |
| |
| Secondary | Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Last Available Visit, Observed Cases, Full Analysis Set Population | | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and last visit (up to 144 weeks). | Posted | | Mean | Standard Deviation | cells/cubic millimeter | | baseline, last available visit (up to 144 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine (NVP) IR / NVP XR | Nevirapine IR during first 48 weeks then switched to NVP XR | | OG001 | Nevirapine IR After Week 48 | Patient remained on NVP IR after week 48 | | OG002 | Nevirapine XR After Week 48 | Patient remained on NVP XR after week 48 |
| |
| Secondary | Proportion of Virologic Response (Viral Load <400 Copies/mL) Trough Week 144 | Endpoint was the number of patients with a sustained virologic response through week 144 | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants present at week 144. | Posted | | Number | | participants | | week 144 | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine (NVP) IR / NVP XR | Nevirapine IR during first 48 weeks then switched to NVP XR | | OG001 | Nevirapine IR After Week 48 | Patient remained on NVP IR after week 48 | | OG002 | Nevirapine XR After Week 48 | Patient remained on NVP XR after week 48 |
| |
| Secondary | Change From Baseline in VL (HIV-1 Viral Load) at Each Visit | | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment, Observed Cases. | Posted | | Mean | Standard Deviation | copies/mL | | week 48, 60, 72, 84, 96, 108, 120, 132, 144, last available visit | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine (NVP) IR / NVP XR | Nevirapine IR during first 48 weeks then switched to NVP XR | | OG001 | Nevirapine IR After Week 48 | Patient remained on NVP IR after week 48 | | OG002 | Nevirapine XR After Week 48 | Patient remained on NVP XR after week 48 |
| |
| Secondary | Changes in Safety Parameters Related to Treatment | Occurence of investigations related to treatment | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. | Posted | | Number | | participants | | until week 144 | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine Immediate Release (NVP IR) | Nevirapine immediate release 200 mg tablets given twice daily | | OG001 | Nevirapine Extended Release (NVP XR) | Nevirapine extended release 400 mg tablets given once daily |
| |
| Secondary | Occurence of Rashes | drug-related rashes by severity | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. | Posted | | Number | | participants | | 144 weeks | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine Immediate Release (NVP IR) | Nevirapine immediate release 200 mg tablets given twice daily | | OG001 | Nevirapine Extended Release (NVP XR) | Nevirapine extended release 400 mg tablets given once daily |
| |
| Secondary | Occurence of Hepatic Events | | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. | Posted | | Number | | participants | | 144 weeks | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine Immediate Release (NVP IR) | Nevirapine immediate release 200 mg tablets given twice daily | | OG001 | Nevirapine Extended Release (NVP XR) | Nevirapine extended release 400 mg tablets given once daily |
| |
| Secondary | New AIDS or AIDS-related Progression Event or Death | | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. | Posted | | Number | | participants | | 144 weeks | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine Immediate Release (NVP IR) | Nevirapine immediate release 200 mg tablets given twice daily | | OG001 | Nevirapine Extended Release (NVP XR) | Nevirapine extended release 400 mg tablets given once daily |
| |
| Secondary | Time to Loss of Virologic Response | Kaplan-Meier Estimates of time to loss of virologic response defined as the time between the start of treatment and the time of treatment failure, up to and including the time when the last patient was on treatment for 48 weeks. | Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. | Posted | | Median | 95% Confidence Interval | days | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine Immediate Release (NVP IR) | Nevirapine immediate release 200 mg tablets given twice daily | | OG001 | Nevirapine Extended Release (NVP XR) | Nevirapine extended release 400 mg tablets given once daily |
| |
| Secondary | Genotypic Resistance Associated With Virologic Failure | Genotypic resistance associated with virologic failure. This endpoint was not analysed due to lack of data. | All patients in the treated set who experienced virologic failure. | Posted | | | | | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine Immediate Release (NVP IR) | Nevirapine immediate release 200 mg tablets given twice daily | | OG001 | Nevirapine Extended Release (NVP XR) | Nevirapine extended release 400 mg tablets given once daily |
| |
| Secondary | Trough Plasma Concentration | Trough plasma concentrations of Nevirapine at steady state after multiple oral administrations of Nevirapine treatments from day 1 (visit 2) to week 48 (visit 9). | All patients with evaluable PK data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Day 1 to week 48 | | | | ID | Title | Description |
|---|
| OG000 | Nevirapine Immediate Release (NVP IR) | Nevirapine immediate release 200 mg tablets given twice daily | | OG001 | Nevirapine Extended Release (NVP XR) | Nevirapine extended release 400 mg tablets given once daily |
| |