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NCT00135369 · ClinicalTrials.gov registry record · Phase 3
Switching HIV-1 Infected Subjects From a Highly Active Anti-Retroviral Treatment (HAART) Regimen Dosed Twice Daily or More Frequently to a Once-Daily Regimen
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 300
- Enrollment target
NCT00135369: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT00135369 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 300 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00135369, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 300 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate that virologically controlled HIV-infected individuals can successfully switch from a standard-of-care regimen dosed twice-daily or more frequently to a simpler once-daily (QD) regimen while maintaining virologic control, as evaluated by the proportion of subjects who continue to have plasma HIV-1 levels \<50 copies/mL after switching to a QD regimen.
Interventions
- DRUG stavudine extended-release, lamivudine, efavirenz
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2002-09 |
| Est. Completion | 2005-07 |
| Phase | Phase 3 |
What the finished NCT00135369 record still lists
NCT00135369 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 1 intervention - of which stavudine extended-release, lamivudine, efavirenz is the first listed.
NCT00135369 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00135369 about?
NCT00135369 is a clinical study titled "Switching HIV-1 Infected Subjects From a Highly Active Anti-Retroviral Treatment (HAART) Regimen Dosed Twice Daily or More Frequently to a Once-Daily Regimen". The purpose of this study is to demonstrate that virologically controlled HIV-infected individuals can successfully switch from a standard-of-care regimen dosed twice-daily or more frequently to a simpler once-daily (QD) regimen while maintaining virologic control, as evaluated by the proportion of ...
What is the current status of trial NCT00135369?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2002-09. Estimated completion is 2005-07.
What interventions are being tested in trial NCT00135369?
The interventions under investigation include: stavudine extended-release, lamivudine, efavirenz (DRUG).
Who is sponsoring clinical trial NCT00135369?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00135369's enrollment target sits among peer trials
300 1122nd of 2000 higher than 840 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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