A Study of Saquinavir/Ritonavir in Liver-Impaired Patients With HIV Infection.

Roche

Status and phase

Completed

Phase 1

Conditions

HIV Infections

Treatments

Drug: saquinavir [Invirase]

Drug: Ritonavir

Study type

Interventional

Funder types

Industry

Identifiers

NCT00435929

BP17921

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

adult patients, 18-65 years of age;
HIV infection;
normal liver function, or moderate liver disease (Child-Pugh grade B);
antiretroviral therapy naive and eligible to take antiretroviral treatment as per treatment guidelines, or treatment experienced for at least 4 weeks prior to first dosing.

Exclusion criteria

severe ascites at screening, or Child-Pugh grade C;
acute infection or current malignancy requiring treatment;
taking any inhibitor of CYP3A4 (with the exception of anti-HIV drugs) within 14 days prior to first dosing;
taking any inducer of CYP3A4 (with the exception of anti-HIV drugs) within 4 weeks prior to pharmacokinetic evaluation (day 14 or 28);
evidence of resistance to saquinavir.