drugset / Trial / NCT00435929
A Study of Saquinavir/Ritonavir in Liver-Impaired Patients With HIV Infection.
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2006-09
- Primary completion
- 2009-11
- Completion
- 2009-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ritonavir | Other / unclassified | 100 mg | Oral |
| Subject | Saquinavir | Small molecule | 1000 mg | Oral |