| Primary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48 | This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 48 weeks of exposure to randomized study drug. | Intent-to-treat, Missing = Failure | Posted | | Number | | percentage of participants | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) | | OG001 | Stavudine or Zidovudine | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00083.3(69.8 to 92.5)
- OG00191.8(80.4 to 97.7)
- OG00285.4(76.3 to 92.0)
|
|
| | 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 |
|---|
| The statistical hypotheses for the primary endpoint was as follows:
- Null Hypothesis: tenofovir DF group is more than 15% worse than the stavudine or zidovudine group with respect to the proportion of participants maintaining HIV-1 RNA concentrations < 400 copies/mL at Week 48.
- Alternate Hypothesis: tenofovir DF group is no more than 15% worse than the stavudine or zidovudine group with respect to the proportion of participants maintaining HIV-1 RNA < 400 copies/mL at Week 48.
| Normal approximation | The difference between the two proportions and its CI were based on normal approximation methods. | | | Difference in percentages between groups | -8.5 | | | 2-Sided | 95 | -21.5 | 4.5 | | | Difference is for tenofovir DF minus stavudine or zidovudine (randomized phase) |
|
| Secondary | Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 400 Copies/mL, Snapshot) | This is the percentage of participants with virologic success after 48 weeks of exposure to randomized study drug. The percentage of participants achieving HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | Intent-to-treat (ITT) Analysis Set; only includes participants < 12 years of age at baseline | Posted | | Number | | percentage of participants | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) | | OG001 | Stavudine or Zidovudine | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) |
| |
| Secondary | Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 50 Copies/mL, Snapshot) | This is the percentage of participants with virologic success after 48 weeks of exposure to randomized study drug. The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | Intent-to-treat (ITT) Analysis Set; only includes participants < 12 years of age at baseline | Posted | | Number | | percentage of participants | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) | | OG001 | Stavudine or Zidovudine | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) |
| |
| Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96 | This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 96 weeks of exposure to TDF. | Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded. | Posted | | Number | | percentage of participants | | 96 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s). | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s) | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases |
| |
| Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144 | This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 144 weeks of exposure to TDF. | Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded. | Posted | | Number | | percentage of participants | | 144 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s) | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s) | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases (All TDF group) |
| |
| Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 192 Weeks | This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 192 weeks of exposure to TDF. | Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded. | Posted | | Number | | percentage of participants | | 192 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s) | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s) | | OG002 | All TDF | All participants who received TDF in the randomized and/or extension phases (All TDF group) |
| |
| Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 240 Weeks | This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 240 weeks of exposure to TDF. | Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded. | Posted | | Number | | percentage of participants | | 240 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s) | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s) | | OG002 | All TDF | All participants who received TDF in the randomized and/or extension phases (All TDF group) |
| |
| Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 288 Weeks | This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 288 weeks of exposure to TDF. | Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded. | Posted | | Number | | percentage of participants | | 288 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s) | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s) | | OG002 | All TDF | All participants who received TDF in the randomized and/or extension phases (All TDF group) |
| |
| Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 336 Weeks | This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 336 weeks of exposure to TDF. | Intent-to-treat, Missing = Excluded | Posted | | Number | | percentage of participants | | 336 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s) | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s) | | OG002 | All TDF | All participants who received TDF in the randomized and/or extension phases (All TDF group) |
| |
| Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 384 Weeks | This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 384 weeks of exposure to TDF. | Intent-to-treat, Missing = Excluded | Posted | | Number | | percentage of participants | | 384 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s) | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s) | | OG002 | All TDF | All participants who received TDF in the randomized and/or extension phases (All TDF group) |
| |
| Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 432 Weeks | This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 432 weeks of exposure to TDF. | Intent-to-treat, Missing = Excluded | Posted | | Number | | percentage of participants | | 432 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s) | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s) | | OG002 | All TDF | All participants who received TDF in the randomized and/or extension phases (All TDF group) |
| |
| Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 480 Weeks | This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 480 weeks of exposure to TDF. | Intent-to-treat, Missing = Excluded | Posted | | Number | | percentage of participants | | 480 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s) | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s) | | OG002 | All TDF | All participants who received TDF in the randomized and/or extension phases (All TDF group) |
| |
| Secondary | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 528 Weeks | This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 528 weeks of exposure to TDF. | Intent-to-treat, Missing = Excluded | Posted | | Number | | percentage of participants | | 528 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s) | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s) | | OG002 | All TDF | All participants who received TDF in the randomized and/or extension phases (All TDF group) |
| |
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 48 Weeks | This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 48 weeks of exposure to randomized study drug. | Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded. | Posted | | Number | | percentage of participants | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) | | OG001 | Stavudine or Zidovudine | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases |
| |
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 96 Weeks | This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 96 weeks of exposure to TDF. | Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded. | Posted | | Number | | percentage of participants | | 96 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s). | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s). | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases |
| |
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 144 Weeks | This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 144 weeks of exposure to TDF. | Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded. | Posted | | Number | | percentage of participants | | 144 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s). | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s). | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases |
| |
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 192 Weeks | This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 192 weeks of exposure to TDF. | Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded. | Posted | | Number | | percentage of participants | | 192 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s). | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s). | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases |
| |
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 240 Weeks | This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 240 weeks of exposure to TDF. | Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded. | Posted | | Number | | percentage of participants | | 240 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s). | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s). | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases |
| |
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 288 Weeks | This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 288 weeks of exposure to TDF. | Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded. | Posted | | Number | | percentage of participants | | 288 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s). | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s). | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases |
| |
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 336 Weeks | This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 336 weeks of exposure to TDF. | Intent-to-treat, Missing = Excluded | Posted | | Number | | percentage of participants | | 336 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s). | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s). | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases |
| |
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 384 Weeks | This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 384 weeks of exposure to TDF. | Intent-to-treat, Missing = Excluded | Posted | | Number | | percentage of participants | | 384 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s). | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s). | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases |
| |
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 432 Weeks | This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 432 weeks of exposure to TDF. | Intent-to-treat, Missing = Excluded | Posted | | Number | | percentage of participants | | 432 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s). | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s). | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases |
| |
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 480 Weeks | This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 480 weeks of exposure to TDF. | Intent-to-treat, Missing = Excluded | Posted | | Number | | percentage of participants | | 480 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s). | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s). | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases |
| |
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 528 Weeks | This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 528 weeks of exposure to TDF. | Intent-to-treat, Missing = Excluded | Posted | | Number | | percentage of participants | | 528 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s). | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s). | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases |
| |
| Secondary | Change From Baseline in CD4 Percentage at 48 Weeks | This is the change from baseline in CD4 percentage after 48 weeks of exposure to randomized study drug. | Intent-to-treat, Missing = Excluded | Posted | | Mean | Standard Deviation | percentage | | Baseline and 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks). | | OG001 | Stavudine or Zidovudine | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks). | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases |
| |
| Secondary | Change From Baseline in CD4 Percentage at 96 Weeks | This is the change from baseline in CD4 percentage after 96 weeks of exposure to TDF. | Intent-to-treat, Missing = Excluded | Posted | | Mean | Standard Deviation | percentage | | Baseline and 96 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s). | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s). | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases |
| |
| Secondary | Change From Baseline in CD4 Percentage at 144 Weeks | This is the change from baseline in CD4 percentage after 144 weeks of exposure to TDF. | Intent-to-treat, Missing = Excluded | Posted | | Mean | Standard Deviation | percentage | | Baseline and 144 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s). | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s). | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases |
| |
| Secondary | Change From Baseline in CD4 Percentage at 192 Weeks | This is the change from baseline in CD4 percentage after 192 weeks of exposure to TDF. | Intent-to-treat, Missing = Excluded | Posted | | Mean | Standard Deviation | percentage | | Baseline and 192 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s). | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s). | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases |
| |
| Secondary | Change From Baseline in CD4 Percentage at 240 Weeks | This is the change from baseline in CD4 percentage after 240 weeks of exposure to TDF. | Intent-to-treat, Missing = Excluded | Posted | | Mean | Standard Deviation | percentage | | Baseline and 240 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s). | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s). | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases |
| |
| Secondary | Change From Baseline in CD4 Percentage at 288 Weeks | This is the change from baseline in CD4 percentage after 288 weeks of exposure to TDF. | Intent-to-treat, Missing = Excluded | Posted | | Mean | Standard Deviation | percentage | | Baseline and 288 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s). | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s). | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases |
| |
| Secondary | Change From Baseline in CD4 Percentage at 336 Weeks | This is the change from baseline in CD4 percentage after 336 weeks of exposure to TDF. | Intent-to-treat, Missing = Excluded | Posted | | Mean | Standard Deviation | percentage | | Baseline and 336 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s). | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s). | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases |
| |
| Secondary | Change From Baseline in CD4 Percentage at 384 Weeks | This is the change from baseline in CD4 percentage after 384 weeks of exposure to TDF. | Intent-to-treat, Missing = Excluded | Posted | | Mean | Standard Deviation | percentage | | Baseline and 384 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s). | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s). | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases |
| |
| Secondary | Change From Baseline in CD4 Percentage at 432 Weeks | This is the change from baseline in CD4 percentage after 432 weeks of exposure to TDF. | Intent-to-treat, Missing = Excluded | Posted | | Mean | Standard Deviation | percentage | | Baseline and 432 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s). | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s). | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases |
| |
| Secondary | Change From Baseline in CD4 Percentage at 480 Weeks | This is the change from baseline in CD4 percentage after 480 weeks of exposure to TDF. | Intent-to-treat, Missing = Excluded | Posted | | Mean | Standard Deviation | percentage | | Baseline and 480 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s). | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s). | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases |
| |
| Secondary | Change From Baseline in CD4 Percentage at 528 Weeks | This is the change from baseline in CD4 percentage after 528 weeks of exposure to TDF. | Intent-to-treat, Missing = Excluded | Posted | | Mean | Standard Deviation | percentage | | Baseline and 528 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s). | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s). | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases |
| |
| Secondary | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 48 Weeks | This is the change from baseline in CD4 cell count after 48 weeks of exposure to randomized study drug. | Intent-to-treat, Missing = Excluded | Posted | | Mean | Standard Deviation | cells/mm^3 | | Baseline and 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks). | | OG001 | Stavudine or Zidovudine | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks). | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases |
| |
| Secondary | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 96 Weeks | This is the change from baseline in CD4 cell count after 96 weeks of exposure to TDF. | Intent-to-treat, Missing = Excluded | Posted | | Mean | Standard Deviation | cells/mm^3 | | Baseline and 96 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s). | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s). | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases |
| |
| Secondary | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 144 Weeks | This is the change from baseline in CD4 cell count after 144 weeks of exposure to TDF. | Intent-to-treat, Missing = Excluded | Posted | | Mean | Standard Deviation | cells/mm^3 | | Baseline and 144 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s). | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s). | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases |
| |
| Secondary | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 192 Weeks | This is the change from baseline in CD4 cell count after 192 weeks of exposure to TDF. | Intent-to-treat, Missing = Excluded | Posted | | Mean | Standard Deviation | cells/mm^3 | | Baseline and 192 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s). | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s). | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases |
| |
| Secondary | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 240 Weeks | This is the change from baseline in CD4 cell count after 240 weeks of exposure to TDF. | Intent-to-treat, Missing = Excluded | Posted | | Mean | Standard Deviation | cells/mm^3 | | Baseline and 240 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s). | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s). | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases |
| |
| Secondary | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 288 Weeks | This is the change from baseline in CD4 cell count after 288 weeks of exposure to TDF. | Intent-to-treat, Missing = Excluded | Posted | | Mean | Standard Deviation | cells/mm^3 | | Baseline and 288 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s). | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s). | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases |
| |
| Secondary | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 336 Weeks | This is the change from baseline in CD4 cell count after 336 weeks of exposure to TDF. | Intent-to-treat, Missing = Excluded | Posted | | Mean | Standard Deviation | cells/mm^3 | | Baseline and 336 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s). | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s). | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases |
| |
| Secondary | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 384 Weeks | This is the change from baseline in CD4 cell count after 384 weeks of exposure to TDF. | Intent-to-treat, Missing = Excluded | Posted | | Mean | Standard Deviation | cells/mm^3 | | Baseline and 384 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s). | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s). | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases |
| |
| Secondary | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 432 Weeks | This is the change from baseline in CD4 cell count after 432 weeks of exposure to TDF. | Intent-to-treat, Missing = Excluded | Posted | | Mean | Standard Deviation | cells/mm^3 | | Baseline and 432 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s). | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s). | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases |
| |
| Secondary | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 480 Weeks | This is the change from baseline in CD4 cell count after 480 weeks of exposure to TDF. | Intent-to-treat, Missing = Excluded | Posted | | Mean | Standard Deviation | cells/mm^3 | | Baseline and 480 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s). | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s). | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases |
| |
| Secondary | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 528 Weeks | This is the change from baseline in CD4 cell count after 528 weeks of exposure to TDF. | Intent-to-treat, Missing = Excluded | Posted | | Mean | Standard Deviation | cells/mm^3 | | Baseline and 528 weeks | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir DF | Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s). | | OG001 | (Stavudine or Zidovudine)/TDF | Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s). | | OG002 | All TDF | All participants who received tenofovir DF in the randomized and/or extension phases |
| |