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NCT00435929 · ClinicalTrials.gov registry record · Phase 1
A Study of Saquinavir/Ritonavir in Liver-Impaired Patients With HIV Infection.
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT00435929: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT00435929 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00435929, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This 2 arm study will assess the effect of moderate liver impairment on the pharmacokinetics of saquinavir and ritonavir at steady state following administration of saquinavir/ritonavir 1000mg/100mg po bid in HIV patients. Saquinavir/ritonavir will be administered concomitantly with 2 to 3 active nucleoside reverse transcriptase inhibitors. The study will compare a group of HIV patients without known liver disease and a group with moderate liver disease. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.
Primary Outcome
Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. The pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the area under the plasma concentration-time curve from 0 to 12 hours after dosing (AUC (0-12h) of SQV and RTV The AUC (0-12hours) was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.
Interventions
- DRUG Ritonavir
- DRUG saquinavir [Invirase]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2006-09 |
| Est. Completion | 2009-11 |
| Phase | Phase 1 |
What the finished NCT00435929 record still lists
NCT00435929 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Ritonavir is the first listed.
NCT00435929 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00435929 about?
NCT00435929 is a clinical study titled "A Study of Saquinavir/Ritonavir in Liver-Impaired Patients With HIV Infection.". This 2 arm study will assess the effect of moderate liver impairment on the pharmacokinetics of saquinavir and ritonavir at steady state following administration of saquinavir/ritonavir 1000mg/100mg po bid in HIV patients. Saquinavir/ritonavir will be administered concomitantly with 2 to 3 active nu...
What is the current status of trial NCT00435929?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2006-09. Estimated completion is 2009-11.
What interventions are being tested in trial NCT00435929?
The interventions under investigation include: Ritonavir (DRUG), saquinavir [Invirase] (DRUG).
Who is sponsoring clinical trial NCT00435929?
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 NCT00435929's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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