A pharmacokinetic study to assess Nevirapine levels in HIV-infected patients with impaired hepatic function.
- Conditions
- Treatment of HIV infection
- Registration Number
- EUCTR2005-000175-17-ES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
- Male or female =18 years of age with HIV-1 infection and chronic liver disease as reflected by a documented biopsy with hepatic fibrosis present.
- Participants must be receiving nevirapine 200 mg twice daily as part of a stable ARV regimen for a minimum of 6 weeks prior to trough level plasma collection.
- Participants must have undergone liver biopsy within 24 months prior to enrollment and have a pathology report and at least one Hematoxylin and Eosin stained slide and one trichrome stained pathology slide available at the time of enrollment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- Current (within past 4 weeks) HIV antiviral theraphy with other NNRTI's and/or any PI.
- Concurrent use (within the past seven days) of any of the following: Systemic azole antifungal agents, Clarithromycin, Rifampin, St. John's Wort
- Patients who have evidence for hepatic or other encephalopathy above Grade 1.
- Patients with renal failure who require dialysis.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the steady state clearance of nevirapine among hepatically impaired patients, and to examine whether the degree of hepatic impairment influences clearance;Secondary Objective: Plasma levels of nevirapine metabolites of all patients and Child-Pugh scores among patients with cirrhosis;Primary end point(s): - Degree of hepatic impairment <br>- steady state nevirapine clearance <br>- increase in estimated clearance when trough is supplemented by plasma levels measured one, two and four hours after nevirapine administration.
- Secondary Outcome Measures
Name Time Method