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NCT00116298 · ClinicalTrials.gov registry record · Phase 3
Rollover Study for Zerit (Stavudine) ER Studies (-096, -099)
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 900
- Enrollment target
NCT00116298: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT00116298 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 900 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00116298, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 900 participants
- Enrollment target
Study Summary
The purpose of this study is to compare long-term safety and tolerability of stavudine (d4T) extended release (ER) versus conventional (immediate release \[IR\]) formulations, each in combination with lamivudine (3TC) and efavirenz (EFV) in subjects who have completed Bristol-Myers Squibb (BMS) studies AI455-096 and AI455-099.
Interventions
- DRUG stavudine, efavirenz, lamivudine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 900 participants |
| Start Date | 2001-01 |
| Est. Completion | 2005-01 |
| Phase | Phase 3 |
What the finished NCT00116298 record still lists
NCT00116298 is an interventional study that assigns participants to a tested intervention. The registered 900 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% higher).
The record links to 0 conditions, and to 1 intervention - of which stavudine, efavirenz, lamivudine is the first listed.
NCT00116298 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00116298 about?
NCT00116298 is a clinical study titled "Rollover Study for Zerit (Stavudine) ER Studies (-096, -099)". The purpose of this study is to compare long-term safety and tolerability of stavudine (d4T) extended release (ER) versus conventional (immediate release \[IR\]) formulations, each in combination with lamivudine (3TC) and efavirenz (EFV) in subjects who have completed Bristol-Myers Squibb (BMS) stud...
What is the current status of trial NCT00116298?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 900 participants. The study started on 2001-01. Estimated completion is 2005-01.
What interventions are being tested in trial NCT00116298?
The interventions under investigation include: stavudine, efavirenz, lamivudine (DRUG).
Who is sponsoring clinical trial NCT00116298?
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 NCT00116298's enrollment target sits among peer trials
900 350th of 2000 higher than 1,641 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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