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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 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 16 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00435929
The ClinicalTrials.gov registry entry for NCT00435929 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ritonavir is the first listed.
NCT00435929 reports 0 study locations.
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.
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