Conditions: HIV Infections
Keywords: Treatment Naive
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 16
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Ritonavir intervention 2: saquinavir [Invirase]
Intervention descriptions: intervention 1: 100mg po bid intervention 2: 1000mg po bid

Protocol document: