A Pharmacokinetic Study to Assess Nevirapine [Viramune] Levels in HIV Infected Patients With Impaired Hepatic Functions
Phase 4
Completed
- Conditions
- HIV InfectionsHepatic Insufficiency
- Registration Number
- NCT00144248
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The objective of this study was to evaluate the steady-state clearance of nevirapine among HIV-1 positive patients with hepatic fibrosis, and to examine whether the degree of hepatic impairment influences clearance.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The primary endpoints are the degree of hepatic impairment, steady state nevirapine clearance, and the increase in estimated clearance when trough is supplemented by plasma levels measured one, two and four hours after nevirapine administration Up to 4 hours
- Secondary Outcome Measures
Name Time Method Plasma levels of nevirapine metabolites of all patients and Child-Pugh scores among patients with cirrhosis. Up to 14 hours
Trial Locations
- Locations (6)
Albany Medical College, MC 142
🇺🇸Albany, New York, United States
Hopital Pitie Salpetriere
🇫🇷Paris, France
Boehringer Ingelheim Investigational Site
🇺🇸Providence, Rhode Island, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
Hopital de l'Hotel Dieu
🇫🇷Lyon cedex 02, France
Hospital Clinico y Provincial de Barcelona - HIV
🇪🇸Barcelona, Spain