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

Status:	Completed
Conditions:	Infectious Disease, HIV / AIDS, HIV / AIDS
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - 65
Updated:	4/17/2018
Start Date:	September 2006
End Date:	November 2009

Effect of Moderate Liver Impairment on the Pharmacokinetics of Saquinavir After Administration of Saquinavir/Ritonavir 1000/100mg BID in HIV Patients

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.

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.

We found this trial at

sites

Clinical Trial Facility in Voorhees New Jersey

Voorhees, New Jersey 08043

from

Voorhees, NJ