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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 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 900 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00116298
The ClinicalTrials.gov registry entry for NCT00116298 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 900 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which stavudine, efavirenz, lamivudine is the first listed.
NCT00116298 reports 0 study locations.
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.
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