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NCT00002208 · ClinicalTrials.gov registry record · Phase 3
A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 Mg q 8 h Versus 1,200 Mg q 12 h in Combination With Zidovudine and 3TC
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 400
- Enrollment target
NCT00002208: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT00002208 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 400 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00002208, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 400 participants
- Enrollment target
Study Summary
To demonstrate that the antiviral activity and safety/tolerability of a test regimen of indinavir is equivalent to that of a control regimen of indinavir when each is coadministered with zidovudine (ZDV) (or stavudine, d4T) and lamivudine (3TC) for 24 weeks to protease inhibitor- and 3TC-naive HIV-1-seropositive patients. To characterize the steady-state pharmacokinetic profiles of indinavir, ZDV (or d4T), and 3TC in the presence of each other, for both the control and test regimen groups.
Interventions
- DRUG Zidovudine
- DRUG Lamivudine
- DRUG Indinavir sulfate
- DRUG Stavudine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Phase | Phase 3 |
What the finished NCT00002208 record still lists
NCT00002208 is an interventional study that assigns participants to a tested intervention. The registered 400 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 (48% lower).
The record links to 0 conditions, and to 4 interventions - of which Zidovudine is the first listed.
NCT00002208 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00002208 about?
NCT00002208 is a clinical study titled "A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 Mg q 8 h Versus 1,200 Mg q 12 h in Combination With Zidovudine and 3TC". To demonstrate that the antiviral activity and safety/tolerability of a test regimen of indinavir is equivalent to that of a control regimen of indinavir when each is coadministered with zidovudine (ZDV) (or stavudine, d4T) and lamivudine (3TC) for 24 weeks to protease inhibitor- and 3TC-naive HIV-1...
What is the current status of trial NCT00002208?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 400 participants.
What interventions are being tested in trial NCT00002208?
The interventions under investigation include: Zidovudine (DRUG), Lamivudine (DRUG), Indinavir sulfate (DRUG), Stavudine (DRUG).
Who is sponsoring clinical trial NCT00002208?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00002208's enrollment target sits among peer trials
400 922nd of 2000 higher than 1,039 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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