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

CompletedPhase 1

Sponsor: Hoffmann-La Roche

Conditions: HIV Infections

Interventions: Ritonavir, saquinavir [Invirase]

Countries: United States, Canada, Puerto Rico

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (8)

Chicago, Illinois, United States
Somers Point, New Jersey, United States
Voorhees Township, New Jersey, United States
Philadelphia, Pennsylvania, United States
Dallas, Texas, United States
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
San Juan, Puerto Rico