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NCT00528957 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 97
- Enrollment target
NCT00528957: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT00528957 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 97 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00528957, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 97 participants
- Enrollment target
Study 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.
Primary Outcome
This is the percentage of participants with HIV-1 RNA \< 400 copies/mL after 48 weeks of exposure to randomized study drug.
Interventions
- DRUG Zidovudine
- DRUG Tenofovir DF
- DRUG Stavudine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2006-12-28 |
| Est. Completion | 2017-08-16 |
| Phase | Phase 3 |
What the finished NCT00528957 record still lists
NCT00528957 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 3 interventions - of which Zidovudine is the first listed.
NCT00528957 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00528957 about?
NCT00528957 is a clinical study titled "Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children". 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.
What is the current status of trial NCT00528957?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 97 participants. The study started on 2006-12-28. Estimated completion is 2017-08-16.
What interventions are being tested in trial NCT00528957?
The interventions under investigation include: Zidovudine (DRUG), Tenofovir DF (DRUG), Stavudine (DRUG).
Who is sponsoring clinical trial NCT00528957?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00528957's enrollment target sits among peer trials
97 1718th of 2000 higher than 283 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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