HIV Infections
Conditions
Keywords
Phase 3, Randomized, Open-Label, Treatment-Experienced, Highly Active Antiretroviral Therapy, HIV, Tenofovir DF, Pediatrics
Brief summary
The primary objective of this study is to assess the efficacy of switching to tenofovir disoproxil fumarate (TDF) compared to continuing stavudine or zidovudine in maintaining virologic suppression in HIV-1 infected children.
Interventions
DRUGTenofovir DF
Tenofovir DF (oral powder or tablet): 300-mg tablets for participants \> 37 kg; 8-mg/kg oral powder (up to 300 mg) for participants ≤ 37 kg. During the extension phase, participants whose weight increases to \> 37 kg may be switched from the oral powder to the tenofovir DF tablet.
DRUGZidovudine
Zidovudine as prescribed by the investigator prior to study entry (pediatric participants \< 30 kg: 1 mg/kg/dose given every 12 hours; pediatric participants ≥ 30 kg: 30 mg twice daily).
DRUGStavudine
Stavudine as prescribed by the investigator prior to study entry (pediatric participants 6 weeks to 12 years of age: 160 mg/m\^2 every 8 hours; pediatric participants \> 12 years of age: 300 mg twice daily).
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
Major Inclusion Criteria: * Documented laboratory diagnosis of HIV-1 infection * Plasma HIV-1 RNA \< 400 copies/mL * Currently on a stable stavudine or zidovudine -containing antiretroviral therapy regimen for at least 12 weeks * Naive to tenofovir DF Key Inclusion Criteria for the First 96-Week Extension * Completed 48 weeks of treatment in Arm 1 or Arm 2 of the study * \<18 years of age (at the start of the extension) * Participants initially randomized to Arm 2 will be given the option to replace stavudine or zidovudine with tenofovir DF in the 96-week extension at the investigator's discretion, if the investigator determines that tenofovir DF is safe and beneficial for the participant. Key Inclusion Criteria for the Second and Third 96-Week Extension and Fourth Open-Ended Extension * Completed of treatment with study drug in the first extension phase * \<18 years of age at the start of the extension. This inclusion criterion is not applicable in those regions where tenofovir DF is not commercially available for treatment of HIV-1 infection in adults. Key
Exclusion criteria
* Participants receiving ongoing therapy with any of the following * Nephrotoxic agents * Systemic chemotherapeutic agents * Systemic corticosteroids * Interleukin 2 (IL 2) and other immunomodulating agents * Investigational agents * Pregnant or lactating participants * Evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting which may confer an inability to receive an orally administered medication * Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance * Malignancy other than cutaneous Kaposi's sarcoma (KS) or basal cell carcinoma. * Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic therapy within 15 days prior to screening * Prior history of significant renal disease (ie, nephrotic syndrome, renal dysgenesis, polycystic kidney disease, congenital nephrosis) * Prior history of significant bone disease (ie, osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochondroses, multiple bone fractures) Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48 | 48 weeks | This is the percentage of participants with HIV-1 RNA \< 400 copies/mL after 48 weeks of exposure to randomized study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 50 Copies/mL, Snapshot) | 48 weeks | 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. |
| Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96 | 96 weeks | This is the percentage of participants with HIV-1 RNA \< 400 copies/mL after 96 weeks of exposure to TDF. |
| Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144 | 144 weeks | This is the percentage of participants with HIV-1 RNA \< 400 copies/mL after 144 weeks of exposure to TDF. |
| Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 192 Weeks | 192 weeks | This is the percentage of participants with HIV-1 RNA \< 400 copies/mL after 192 weeks of exposure to TDF. |
| Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 240 Weeks | 240 weeks | This is the percentage of participants with HIV-1 RNA \< 400 copies/mL after 240 weeks of exposure to TDF. |
| Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 288 Weeks | 288 weeks | This is the percentage of participants with HIV-1 RNA \< 400 copies/mL after 288 weeks of exposure to TDF. |
| Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 336 Weeks | 336 weeks | This is the percentage of participants with HIV-1 RNA \< 400 copies/mL after 336 weeks of exposure to TDF. |
| Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 384 Weeks | 384 weeks | This is the percentage of participants with HIV-1 RNA \< 400 copies/mL after 384 weeks of exposure to TDF. |
| Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 432 Weeks | 432 weeks | This is the percentage of participants with HIV-1 RNA \< 400 copies/mL after 432 weeks of exposure to TDF. |
| Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 480 Weeks | 480 weeks | This is the percentage of participants with HIV-1 RNA \< 400 copies/mL after 480 weeks of exposure to TDF. |
| Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 528 Weeks | 528 weeks | This is the percentage of participants with HIV-1 RNA \< 400 copies/mL after 528 weeks of exposure to TDF. |
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 48 Weeks | 48 weeks | This is the percentage of participants with HIV-1 RNA \< 50 copies/mL after 48 weeks of exposure to randomized study drug. |
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 96 Weeks | 96 weeks | This is the percentage of participants with HIV-1 RNA \< 50 copies/mL after 96 weeks of exposure to TDF. |
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 144 Weeks | 144 weeks | This is the percentage of participants with HIV-1 RNA \< 50 copies/mL after 144 weeks of exposure to TDF. |
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 192 Weeks | 192 weeks | This is the percentage of participants with HIV-1 RNA \< 50 copies/mL after 192 weeks of exposure to TDF. |
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 240 Weeks | 240 weeks | This is the percentage of participants with HIV-1 RNA \< 50 copies/mL after 240 weeks of exposure to TDF. |
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 288 Weeks | 288 weeks | This is the percentage of participants with HIV-1 RNA \< 50 copies/mL after 288 weeks of exposure to TDF. |
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 336 Weeks | 336 weeks | This is the percentage of participants with HIV-1 RNA \< 50 copies/mL after 336 weeks of exposure to TDF. |
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 384 Weeks | 384 weeks | This is the percentage of participants with HIV-1 RNA \< 50 copies/mL after 384 weeks of exposure to TDF. |
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 432 Weeks | 432 weeks | This is the percentage of participants with HIV-1 RNA \< 50 copies/mL after 432 weeks of exposure to TDF. |
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 480 Weeks | 480 weeks | This is the percentage of participants with HIV-1 RNA \< 50 copies/mL after 480 weeks of exposure to TDF. |
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 528 Weeks | 528 weeks | This is the percentage of participants with HIV-1 RNA \< 50 copies/mL after 528 weeks of exposure to TDF. |
| Change From Baseline in CD4 Percentage at 48 Weeks | Baseline and 48 weeks | This is the change from baseline in CD4 percentage after 48 weeks of exposure to randomized study drug. |
| Change From Baseline in CD4 Percentage at 96 Weeks | Baseline and 96 weeks | This is the change from baseline in CD4 percentage after 96 weeks of exposure to TDF. |
| Change From Baseline in CD4 Percentage at 144 Weeks | Baseline and 144 weeks | This is the change from baseline in CD4 percentage after 144 weeks of exposure to TDF. |
| Change From Baseline in CD4 Percentage at 192 Weeks | Baseline and 192 weeks | This is the change from baseline in CD4 percentage after 192 weeks of exposure to TDF. |
| Change From Baseline in CD4 Percentage at 240 Weeks | Baseline and 240 weeks | This is the change from baseline in CD4 percentage after 240 weeks of exposure to TDF. |
| Change From Baseline in CD4 Percentage at 288 Weeks | Baseline and 288 weeks | This is the change from baseline in CD4 percentage after 288 weeks of exposure to TDF. |
| Change From Baseline in CD4 Percentage at 336 Weeks | Baseline and 336 weeks | This is the change from baseline in CD4 percentage after 336 weeks of exposure to TDF. |
| Change From Baseline in CD4 Percentage at 384 Weeks | Baseline and 384 weeks | This is the change from baseline in CD4 percentage after 384 weeks of exposure to TDF. |
| Change From Baseline in CD4 Percentage at 432 Weeks | Baseline and 432 weeks | This is the change from baseline in CD4 percentage after 432 weeks of exposure to TDF. |
| Change From Baseline in CD4 Percentage at 480 Weeks | Baseline and 480 weeks | This is the change from baseline in CD4 percentage after 480 weeks of exposure to TDF. |
| Change From Baseline in CD4 Percentage at 528 Weeks | Baseline and 528 weeks | This is the change from baseline in CD4 percentage after 528 weeks of exposure to TDF. |
| Change From Baseline in CD4 Cell Count (Cells/mm^3) at 48 Weeks | Baseline and 48 weeks | This is the change from baseline in CD4 cell count after 48 weeks of exposure to randomized study drug. |
| Change From Baseline in CD4 Cell Count (Cells/mm^3) at 96 Weeks | Baseline and 96 weeks | This is the change from baseline in CD4 cell count after 96 weeks of exposure to TDF. |
| Change From Baseline in CD4 Cell Count (Cells/mm^3) at 144 Weeks | Baseline and 144 weeks | This is the change from baseline in CD4 cell count after 144 weeks of exposure to TDF. |
| Change From Baseline in CD4 Cell Count (Cells/mm^3) at 192 Weeks | Baseline and 192 weeks | This is the change from baseline in CD4 cell count after 192 weeks of exposure to TDF. |
| Change From Baseline in CD4 Cell Count (Cells/mm^3) at 240 Weeks | Baseline and 240 weeks | This is the change from baseline in CD4 cell count after 240 weeks of exposure to TDF. |
| Change From Baseline in CD4 Cell Count (Cells/mm^3) at 288 Weeks | Baseline and 288 weeks | This is the change from baseline in CD4 cell count after 288 weeks of exposure to TDF. |
| Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 400 Copies/mL, Snapshot) | 48 weeks | 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. |
| Change From Baseline in CD4 Cell Count (Cells/mm^3) at 384 Weeks | Baseline and 384 weeks | This is the change from baseline in CD4 cell count after 384 weeks of exposure to TDF. |
| Change From Baseline in CD4 Cell Count (Cells/mm^3) at 432 Weeks | Baseline and 432 weeks | This is the change from baseline in CD4 cell count after 432 weeks of exposure to TDF. |
| Change From Baseline in CD4 Cell Count (Cells/mm^3) at 480 Weeks | Baseline and 480 weeks | This is the change from baseline in CD4 cell count after 480 weeks of exposure to TDF. |
| Change From Baseline in CD4 Cell Count (Cells/mm^3) at 528 Weeks | Baseline and 528 weeks | This is the change from baseline in CD4 cell count after 528 weeks of exposure to TDF. |
| Change From Baseline in CD4 Cell Count (Cells/mm^3) at 336 Weeks | Baseline and 336 weeks | This is the change from baseline in CD4 cell count after 336 weeks of exposure to TDF. |
Countries
Panama, United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled at study sites in the United States, Panama, and the United Kingdom. The first participant was screened on 28 December 2006. The last study visit occurred on 16 August 2017.
Pre-assignment details
127 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| Tenofovir DF Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s). | 48 |
| Stavudine or Zidovudine Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s). | 49 |
| Total | 97 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Extension (Week 48 to Week 144) | Investigator's Discretion | 2 | 0 |
| First Extension (Week 48 to Week 144) | Safety, Tolerability, or Efficacy Reason | 1 | 0 |
| First Extension (Week 48 to Week 144) | Withdrew Consent | 0 | 1 |
| Long-Term Extension (Week 336 and On) | Investigator's Discretion | 1 | 1 |
| Long-Term Extension (Week 336 and On) | Rolled Over to Study GS-US-311-1269 | 4 | 10 |
| Long-Term Extension (Week 336 and On) | Safety, Tolerability, or Efficacy Reason | 3 | 5 |
| Long-Term Extension (Week 336 and On) | Withdrew Consent | 2 | 1 |
| Randomized Phase (Baseline to Week 48) | Safety, Tolerability, or Efficacy Reason | 2 | 0 |
| Randomized Phase (Baseline to Week 48) | Withdrew Consent | 2 | 1 |
| Second Extension (Week 144 to Week 240) | Investigator's Discretion | 3 | 0 |
| Second Extension (Week 144 to Week 240) | Safety, Tolerability, or Efficacy Reason | 4 | 3 |
| Third Extension (Week 240 to Week 336) | = 18 yr old & TDF approved in adults | 1 | 1 |
| Third Extension (Week 240 to Week 336) | Investigator's Discretion | 0 | 1 |
| Third Extension (Week 240 to Week 336) | Lost to Follow-up | 0 | 3 |
| Third Extension (Week 240 to Week 336) | Safety, Tolerability, or Efficacy Reason | 5 | 4 |
| Third Extension (Week 240 to Week 336) | Withdrew Consent | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Tenofovir DF | Stavudine or Zidovudine |
|---|---|---|---|
| Age, Continuous | 7 years STANDARD_DEVIATION 3 | 7 years STANDARD_DEVIATION 3.3 | 7 years STANDARD_DEVIATION 2.6 |
| Body Mass Index | 17.08 kg/m^2 STANDARD_DEVIATION 2.905 | 17.59 kg/m^2 STANDARD_DEVIATION 3.68 | 16.59 kg/m^2 STANDARD_DEVIATION 1.762 |
| CD4 Cell Count | 1167 cells/mm^3 STANDARD_DEVIATION 468.6 | 1190 cells/mm^3 STANDARD_DEVIATION 541.7 | 1144 cells/mm^3 STANDARD_DEVIATION 388.4 |
| CD4 Percentage | 33.5 percentage STANDARD_DEVIATION 7.11 | 33.9 percentage STANDARD_DEVIATION 7.44 | 33.0 percentage STANDARD_DEVIATION 6.82 |
| Height | 119 cm STANDARD_DEVIATION 18.2 | 118 cm STANDARD_DEVIATION 19.8 | 119 cm STANDARD_DEVIATION 16.7 |
| Plasma HIV-1 RNA ≥ 1000 copies/mL | 1 Participants | 0 Participants | 1 Participants |
| Plasma HIV-1 RNA 400 to < 1000 copies/mL | 2 Participants | 1 Participants | 1 Participants |
| Plasma HIV-1 RNA < 50 copies/mL | 77 Participants | 36 Participants | 41 Participants |
| Plasma HIV-1 RNA 50 to < 400 copies/mL | 17 Participants | 11 Participants | 6 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 19 Participants | 13 Participants | 6 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 77 Participants | 35 Participants | 42 Participants |
| Race/Ethnicity, Customized Mestizo | 65 Participants | 28 Participants | 37 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Indian (Kuna) | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 20 Participants | 13 Participants | 7 Participants |
| Race/Ethnicity, Customized White | 9 Participants | 3 Participants | 6 Participants |
| Region of Enrollment Panama | 72 Participants | 33 Participants | 39 Participants |
| Region of Enrollment United Kingdom | 3 Participants | 2 Participants | 1 Participants |
| Region of Enrollment United States | 22 Participants | 13 Participants | 9 Participants |
| Sex: Female, Male Female | 47 Participants | 27 Participants | 20 Participants |
| Sex: Female, Male Male | 50 Participants | 21 Participants | 29 Participants |
| Weight | 25.0 kilograms STANDARD_DEVIATION 10.09 | 25.9 kilograms STANDARD_DEVIATION 12.03 | 24.1 kilograms STANDARD_DEVIATION 7.77 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 49 | 0 / 89 |
| other Total, other adverse events | 37 / 48 | 35 / 49 | 82 / 89 |
| serious Total, serious adverse events | 2 / 48 | 2 / 49 | 15 / 89 |
Outcome results
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.
Time frame: 48 weeks
Population: Intent-to-treat, Missing = Failure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tenofovir DF | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48 | 83.3 percentage of participants |
| Stavudine or Zidovudine | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48 | 91.8 percentage of participants |
| All TDF | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48 | 85.4 percentage of participants |
Comparison: 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 48.95% CI: [-21.5, 4.5]Normal approximation
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.
Time frame: Baseline and 144 weeks
Population: Intent-to-treat, Missing = Excluded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tenofovir DF | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 144 Weeks | -139 cells/mm^3 | Standard Deviation 438.2 |
| Stavudine or Zidovudine | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 144 Weeks | -146 cells/mm^3 | Standard Deviation 245.3 |
| All TDF | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 144 Weeks | -142 cells/mm^3 | Standard Deviation 345.9 |
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.
Time frame: Baseline and 192 weeks
Population: Intent-to-treat, Missing = Excluded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tenofovir DF | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 192 Weeks | -304 cells/mm^3 | Standard Deviation 529 |
| Stavudine or Zidovudine | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 192 Weeks | -177 cells/mm^3 | Standard Deviation 288.5 |
| All TDF | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 192 Weeks | -233 cells/mm^3 | Standard Deviation 413.2 |
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.
Time frame: Baseline and 240 weeks
Population: Intent-to-treat, Missing = Excluded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tenofovir DF | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 240 Weeks | -369 cells/mm^3 | Standard Deviation 529.9 |
| Stavudine or Zidovudine | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 240 Weeks | -296 cells/mm^3 | Standard Deviation 252.6 |
| All TDF | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 240 Weeks | -329 cells/mm^3 | Standard Deviation 401.7 |
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.
Time frame: Baseline and 288 weeks
Population: Intent-to-treat, Missing = Excluded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tenofovir DF | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 288 Weeks | -346 cells/mm^3 | Standard Deviation 507.5 |
| Stavudine or Zidovudine | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 288 Weeks | -256 cells/mm^3 | Standard Deviation 292.5 |
| All TDF | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 288 Weeks | -302 cells/mm^3 | Standard Deviation 414.6 |
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.
Time frame: Baseline and 336 weeks
Population: Intent-to-treat, Missing = Excluded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tenofovir DF | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 336 Weeks | -415 cells/mm^3 | Standard Deviation 569.4 |
| Stavudine or Zidovudine | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 336 Weeks | -283 cells/mm^3 | Standard Deviation 252.2 |
| All TDF | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 336 Weeks | -350 cells/mm^3 | Standard Deviation 443.8 |
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.
Time frame: Baseline and 384 weeks
Population: Intent-to-treat, Missing = Excluded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tenofovir DF | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 384 Weeks | -620 cells/mm^3 | Standard Deviation 635.6 |
| Stavudine or Zidovudine | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 384 Weeks | -305 cells/mm^3 | Standard Deviation 238.2 |
| All TDF | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 384 Weeks | -512 cells/mm^3 | Standard Deviation 548.8 |
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.
Time frame: Baseline and 432 weeks
Population: Intent-to-treat, Missing = Excluded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tenofovir DF | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 432 Weeks | -795 cells/mm^3 | Standard Deviation 559.2 |
| Stavudine or Zidovudine | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 432 Weeks | -302 cells/mm^3 | Standard Deviation 355.2 |
| All TDF | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 432 Weeks | -631 cells/mm^3 | Standard Deviation 545.7 |
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.
Time frame: Baseline and 480 weeks
Population: Intent-to-treat, Missing = Excluded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tenofovir DF | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 480 Weeks | -923 cells/mm^3 | Standard Deviation 755.4 |
| Stavudine or Zidovudine | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 480 Weeks | -448 cells/mm^3 | Standard Deviation 469.9 |
| All TDF | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 480 Weeks | -813 cells/mm^3 | Standard Deviation 712.9 |
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.
Time frame: Baseline and 48 weeks
Population: Intent-to-treat, Missing = Excluded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tenofovir DF | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 48 Weeks | -97 cells/mm^3 | Standard Deviation 416.4 |
| Stavudine or Zidovudine | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 48 Weeks | -11 cells/mm^3 | Standard Deviation 280.2 |
| All TDF | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 48 Weeks | 2 cells/mm^3 | Standard Deviation 385.9 |
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.
Time frame: Baseline and 528 weeks
Population: Intent-to-treat, Missing = Excluded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tenofovir DF | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 528 Weeks | -710 cells/mm^3 | Standard Deviation 447 |
| All TDF | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 528 Weeks | -710 cells/mm^3 | Standard Deviation 447 |
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.
Time frame: Baseline and 96 weeks
Population: Intent-to-treat, Missing = Excluded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tenofovir DF | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 96 Weeks | -77 cells/mm^3 | Standard Deviation 408.3 |
| Stavudine or Zidovudine | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 96 Weeks | -56 cells/mm^3 | Standard Deviation 305.6 |
| All TDF | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 96 Weeks | -67 cells/mm^3 | Standard Deviation 358.3 |
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.
Time frame: Baseline and 144 weeks
Population: Intent-to-treat, Missing = Excluded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tenofovir DF | Change From Baseline in CD4 Percentage at 144 Weeks | 0.8 percentage | Standard Deviation 5.61 |
| Stavudine or Zidovudine | Change From Baseline in CD4 Percentage at 144 Weeks | -0.1 percentage | Standard Deviation 3.83 |
| All TDF | Change From Baseline in CD4 Percentage at 144 Weeks | 0.3 percentage | Standard Deviation 4.73 |
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.
Time frame: Baseline and 192 weeks
Population: Intent-to-treat, Missing = Excluded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tenofovir DF | Change From Baseline in CD4 Percentage at 192 Weeks | 1.1 percentage | Standard Deviation 5.57 |
| Stavudine or Zidovudine | Change From Baseline in CD4 Percentage at 192 Weeks | 0.6 percentage | Standard Deviation 3.69 |
| All TDF | Change From Baseline in CD4 Percentage at 192 Weeks | 0.8 percentage | Standard Deviation 4.58 |
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.
Time frame: Baseline and 240 weeks
Population: Intent-to-treat, Missing = Excluded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tenofovir DF | Change From Baseline in CD4 Percentage at 240 Weeks | 1.3 percentage | Standard Deviation 5.98 |
| Stavudine or Zidovudine | Change From Baseline in CD4 Percentage at 240 Weeks | -0.9 percentage | Standard Deviation 4.13 |
| All TDF | Change From Baseline in CD4 Percentage at 240 Weeks | 0.1 percentage | Standard Deviation 5.16 |
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.
Time frame: Baseline and 288 weeks
Population: Intent-to-treat, Missing = Excluded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tenofovir DF | Change From Baseline in CD4 Percentage at 288 Weeks | 2.0 percentage | Standard Deviation 6.3 |
| Stavudine or Zidovudine | Change From Baseline in CD4 Percentage at 288 Weeks | 0.5 percentage | Standard Deviation 4.77 |
| All TDF | Change From Baseline in CD4 Percentage at 288 Weeks | 1.3 percentage | Standard Deviation 5.58 |
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.
Time frame: Baseline and 336 weeks
Population: Intent-to-treat, Missing = Excluded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tenofovir DF | Change From Baseline in CD4 Percentage at 336 Weeks | 2.0 percentage | Standard Deviation 7.19 |
| Stavudine or Zidovudine | Change From Baseline in CD4 Percentage at 336 Weeks | 0.8 percentage | Standard Deviation 4.01 |
| All TDF | Change From Baseline in CD4 Percentage at 336 Weeks | 1.4 percentage | Standard Deviation 5.82 |
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.
Time frame: Baseline and 384 weeks
Population: Intent-to-treat, Missing = Excluded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tenofovir DF | Change From Baseline in CD4 Percentage at 384 Weeks | 0.5 percentage | Standard Deviation 7.8 |
| Stavudine or Zidovudine | Change From Baseline in CD4 Percentage at 384 Weeks | 1.6 percentage | Standard Deviation 1.9 |
| All TDF | Change From Baseline in CD4 Percentage at 384 Weeks | 0.9 percentage | Standard Deviation 6.37 |
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.
Time frame: Baseline and 432 weeks
Population: Intent-to-treat, Missing = Excluded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tenofovir DF | Change From Baseline in CD4 Percentage at 432 Weeks | 0.3 percentage | Standard Deviation 6.41 |
| Stavudine or Zidovudine | Change From Baseline in CD4 Percentage at 432 Weeks | 2.9 percentage | Standard Deviation 3.53 |
| All TDF | Change From Baseline in CD4 Percentage at 432 Weeks | 1.1 percentage | Standard Deviation 5.66 |
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.
Time frame: Baseline and 480 weeks
Population: Intent-to-treat, Missing = Excluded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tenofovir DF | Change From Baseline in CD4 Percentage at 480 Weeks | 2.3 percentage | Standard Deviation 7.15 |
| Stavudine or Zidovudine | Change From Baseline in CD4 Percentage at 480 Weeks | 5.0 percentage | Standard Deviation 10 |
| All TDF | Change From Baseline in CD4 Percentage at 480 Weeks | 2.9 percentage | Standard Deviation 7.51 |
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.
Time frame: Baseline and 48 weeks
Population: Intent-to-treat, Missing = Excluded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tenofovir DF | Change From Baseline in CD4 Percentage at 48 Weeks | 0.3 percentage | Standard Deviation 4.49 |
| Stavudine or Zidovudine | Change From Baseline in CD4 Percentage at 48 Weeks | 1.1 percentage | Standard Deviation 4.73 |
| All TDF | Change From Baseline in CD4 Percentage at 48 Weeks | 0.6 percentage | Standard Deviation 3.85 |
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.
Time frame: Baseline and 528 weeks
Population: Intent-to-treat, Missing = Excluded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tenofovir DF | Change From Baseline in CD4 Percentage at 528 Weeks | 4.5 percentage | Standard Deviation 3.89 |
| All TDF | Change From Baseline in CD4 Percentage at 528 Weeks | 4.5 percentage | Standard Deviation 3.89 |
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.
Time frame: Baseline and 96 weeks
Population: Intent-to-treat, Missing = Excluded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tenofovir DF | Change From Baseline in CD4 Percentage at 96 Weeks | 1.3 percentage | Standard Deviation 4.08 |
| Stavudine or Zidovudine | Change From Baseline in CD4 Percentage at 96 Weeks | -0.1 percentage | Standard Deviation 3.6 |
| All TDF | Change From Baseline in CD4 Percentage at 96 Weeks | 0.6 percentage | Standard Deviation 3.88 |
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.
Time frame: 192 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tenofovir DF | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 192 Weeks | 70.6 percentage of participants |
| Stavudine or Zidovudine | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 192 Weeks | 82.5 percentage of participants |
| All TDF | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 192 Weeks | 77.0 percentage of participants |
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.
Time frame: 240 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tenofovir DF | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 240 Weeks | 70.6 percentage of participants |
| Stavudine or Zidovudine | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 240 Weeks | 75.7 percentage of participants |
| All TDF | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 240 Weeks | 73.2 percentage of participants |
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.
Time frame: 288 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tenofovir DF | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 288 Weeks | 81.5 percentage of participants |
| Stavudine or Zidovudine | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 288 Weeks | 67.6 percentage of participants |
| All TDF | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 288 Weeks | 73.4 percentage of participants |
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.
Time frame: 336 weeks
Population: Intent-to-treat, Missing = Excluded
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tenofovir DF | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 336 Weeks | 90.9 percentage of participants |
| Stavudine or Zidovudine | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 336 Weeks | 100.0 percentage of participants |
| All TDF | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 336 Weeks | 95.3 percentage of participants |
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.
Time frame: 384 weeks
Population: Intent-to-treat, Missing = Excluded
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tenofovir DF | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 384 Weeks | 100.0 percentage of participants |
| Stavudine or Zidovudine | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 384 Weeks | 100.0 percentage of participants |
| All TDF | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 384 Weeks | 100.0 percentage of participants |
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.
Time frame: 432 weeks
Population: Intent-to-treat, Missing = Excluded
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tenofovir DF | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 432 Weeks | 100.0 percentage of participants |
| Stavudine or Zidovudine | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 432 Weeks | 85.7 percentage of participants |
| All TDF | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 432 Weeks | 95.0 percentage of participants |
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.
Time frame: 480 weeks
Population: Intent-to-treat, Missing = Excluded
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tenofovir DF | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 480 Weeks | 88.9 percentage of participants |
| Stavudine or Zidovudine | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 480 Weeks | 100.0 percentage of participants |
| All TDF | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 480 Weeks | 90.9 percentage of participants |
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.
Time frame: 528 weeks
Population: Intent-to-treat, Missing = Excluded
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tenofovir DF | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 528 Weeks | 100.0 percentage of participants |
| All TDF | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 528 Weeks | 100.0 percentage of participants |
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.
Time frame: 144 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tenofovir DF | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144 | 73.7 percentage of participants |
| Stavudine or Zidovudine | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144 | 87.5 percentage of participants |
| All TDF | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144 | 80.8 percentage of participants |
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.
Time frame: 96 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tenofovir DF | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96 | 81.6 percentage of participants |
| Stavudine or Zidovudine | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96 | 85.4 percentage of participants |
| All TDF | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96 | 83.5 percentage of participants |
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.
Time frame: 144 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tenofovir DF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 144 Weeks | 63.2 percentage of participants |
| Stavudine or Zidovudine | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 144 Weeks | 75.0 percentage of participants |
| All TDF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 144 Weeks | 69.2 percentage of participants |
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.
Time frame: 192 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tenofovir DF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 192 Weeks | 67.6 percentage of participants |
| Stavudine or Zidovudine | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 192 Weeks | 75.0 percentage of participants |
| All TDF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 192 Weeks | 71.6 percentage of participants |
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.
Time frame: 240 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tenofovir DF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 240 Weeks | 70.6 percentage of participants |
| Stavudine or Zidovudine | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 240 Weeks | 73.0 percentage of participants |
| All TDF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 240 Weeks | 71.8 percentage of participants |
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.
Time frame: 288 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tenofovir DF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 288 Weeks | 81.5 percentage of participants |
| Stavudine or Zidovudine | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 288 Weeks | 62.2 percentage of participants |
| All TDF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 288 Weeks | 70.3 percentage of participants |
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.
Time frame: 336 weeks
Population: Intent-to-treat, Missing = Excluded
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tenofovir DF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 336 Weeks | 86.4 percentage of participants |
| Stavudine or Zidovudine | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 336 Weeks | 90.5 percentage of participants |
| All TDF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 336 Weeks | 88.4 percentage of participants |
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.
Time frame: 384 weeks
Population: Intent-to-treat, Missing = Excluded
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tenofovir DF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 384 Weeks | 88.2 percentage of participants |
| Stavudine or Zidovudine | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 384 Weeks | 100.0 percentage of participants |
| All TDF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 384 Weeks | 92.3 percentage of participants |
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.
Time frame: 432 weeks
Population: Intent-to-treat, Missing = Excluded
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tenofovir DF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 432 Weeks | 100.0 percentage of participants |
| Stavudine or Zidovudine | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 432 Weeks | 71.4 percentage of participants |
| All TDF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 432 Weeks | 90.0 percentage of participants |
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.
Time frame: 480 weeks
Population: Intent-to-treat, Missing = Excluded
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tenofovir DF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 480 Weeks | 77.8 percentage of participants |
| Stavudine or Zidovudine | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 480 Weeks | 50.0 percentage of participants |
| All TDF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 480 Weeks | 72.7 percentage of participants |
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.
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tenofovir DF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 48 Weeks | 70.8 percentage of participants |
| Stavudine or Zidovudine | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 48 Weeks | 85.7 percentage of participants |
| All TDF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 48 Weeks | 68.5 percentage of participants |
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.
Time frame: 528 weeks
Population: Intent-to-treat, Missing = Excluded
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tenofovir DF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 528 Weeks | 100.0 percentage of participants |
| All TDF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 528 Weeks | 100.0 percentage of participants |
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.
Time frame: 96 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tenofovir DF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 96 Weeks | 76.3 percentage of participants |
| Stavudine or Zidovudine | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 96 Weeks | 68.3 percentage of participants |
| All TDF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 96 Weeks | 72.2 percentage of participants |
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.
Time frame: 48 weeks
Population: Intent-to-treat (ITT) Analysis Set; only includes participants \< 12 years of age at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tenofovir DF | Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 400 Copies/mL, Snapshot) | 88.6 percentage of participants |
| Stavudine or Zidovudine | Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 400 Copies/mL, Snapshot) | 89.6 percentage of participants |
95% CI: [-13.7, 11.8]
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.
Time frame: 48 weeks
Population: Intent-to-treat (ITT) Analysis Set; only includes participants \< 12 years of age at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tenofovir DF | Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 50 Copies/mL, Snapshot) | 75.0 percentage of participants |
| Stavudine or Zidovudine | Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 50 Copies/mL, Snapshot) | 81.3 percentage of participants |