Trial information
A Study of Saquinavir/Ritonavir in Liver-Impaired Patients With HIV Infection.
Status: Recruiting
Protocol number: BP17921
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: Effect of moderate liver impairment on the pharmacokinetics of saquinavir after administration of saquinavir/ritonavir 1000/100mg BID in HIV patients
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. Target sample size is 40.
Study phase: I
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Parallel; Pharmacokinetics study
Condition: HIV Infections
Intervention type: Drug
Intervention name: saquinavir [Invirase]
Primary outcome: 1. AUC, Cmax of SQV and RTV Time frame: Day 14
Key secondary outcomes: 1. Tmax, T1/2, CL/F, Cmin, Vd Time frame: Day 14
2. HIV-1 RNA viral load, CD4, HCV-RNA viral load, HBV-DNA viral load. Time frame: Days 8 and 14
3. AEs, laboratory parameters. Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: 65 Years
Accepts healthy volunteers: No
Anticipated start date: September, 2006
Trial registration date: 02/16/2007
Date last updated: 10/15/2008
Link to trial result
This trial is being conducted at the following locations:
Canada
United States
- Somers Point, NJ
- Philadelphia, PA
- Santurce, PR
