A Study of Saquinavir/Ritonavir in Liver-Impaired Patients With HIV Infection.
Completed · Phase 1
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00435929
- Run by
- Hoffmann-La Roche
- People needed
- 16
- Starts
- 2006-09-01
- Expected to finish
- 2009-11-01
- Last updated by the study team
- 2018-03-29
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Study site — Chicago, Illinois, United States
- Study site — Somers Point, New Jersey, United States
- Study site — Voorhees Township, New Jersey, United States
- Study site — Philadelphia, Pennsylvania, United States
- Study site — Dallas, Texas, United States
- Study site — Ottawa, Ontario, Canada
- Study site — Toronto, Ontario, Canada
- Study site — San Juan, Puerto Rico
Full record on ClinicalTrials.gov
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