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NCT00002397 · ClinicalTrials.gov registry record · Phase 3
A Study of Saquinavir Soft Gel Capsules (SGC) Used in Combination With Two Other Anti-HIV Drugs in Patients With HIV-Associated Kidney Disease
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 24
- Enrollment target
NCT00002397: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT00002397 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 24 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00002397, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the safety and effectiveness of saquinavir SGC plus stavudine (d4T) plus lamivudine (3TC) with that of saquinavir SGC plus nelfinavir plus d4T in patients with HIV-associated kidney disease. This study examines whether these drug combinations are effective in preventing kidney disease from progressing to a stage where it is immediately life threatening. This study also examines the effect these drug combinations have on the level of HIV detected in these patients. Finally, this study evaluates the drug level (the amount of drug found in the body) of these two combinations in patients with kidney disease.
Interventions
- DRUG Lamivudine
- DRUG Stavudine
- DRUG Nelfinavir mesylate
- DRUG Saquinavir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Phase | Phase 3 |
What the finished NCT00002397 record still lists
NCT00002397 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 4 interventions - of which Lamivudine is the first listed.
NCT00002397 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00002397 about?
NCT00002397 is a clinical study titled "A Study of Saquinavir Soft Gel Capsules (SGC) Used in Combination With Two Other Anti-HIV Drugs in Patients With HIV-Associated Kidney Disease". The purpose of this study is to compare the safety and effectiveness of saquinavir SGC plus stavudine (d4T) plus lamivudine (3TC) with that of saquinavir SGC plus nelfinavir plus d4T in patients with HIV-associated kidney disease. This study examines whether these drug combinations are effective in ...
What is the current status of trial NCT00002397?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 24 participants.
What interventions are being tested in trial NCT00002397?
The interventions under investigation include: Lamivudine (DRUG), Stavudine (DRUG), Nelfinavir mesylate (DRUG), Saquinavir (DRUG).
Who is sponsoring clinical trial NCT00002397?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00002397's enrollment target sits among peer trials
24 1943rd of 2000 higher than 49 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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