Clinical Trial Protocol Registry
A Study of Saquinavir/Ritonavir in Liver-Impaired Patients With HIV Infection.
- Protocol number:
- Hoffmann-La Roche
- Company division:
- 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 16.
- Study phase:
- Study type:
- Interventional; Treatment; Non-randomized; Open Label; Uncontrolled; Parallel; Pharmacokinetics study
- HIV Infections
- Intervention type:
- Intervention name:
- saquinavir [Invirase]
- Primary outcome:
- AUC, Cmax of SQV and RTV Time frame: Day 14
- Key secondary outcomes:
- Tmax, T1/2, CL/F, Cmin, Vd Time frame: Day 14
- HIV-1 RNA viral load, CD4, HCV-RNA viral load, HBV-DNA viral load. Time frame: Days 8 and 14
- 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.
- Males or Females
- Age limits:
- Min: 18 years Max: 65 years
- Accepts healthy volunteers:
- Anticipated start date:
- September, 2006
- Trial registration date:
- Date last updated:
- OTTAWA, ON
- TORONTO, ON
- CHICAGO, IL
- SOMERS POINT, NJ
- VOORHEES, NJ
- PHILADELPHIA, PA
- SAN JUAN, PR
- DALLAS, TX
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