EUCTR2005-000175-17-ESActive, not recruitingPhase 1
A pharmacokinetic study to assess Nevirapine levels in HIV-infected patients with impaired hepatic function.
Not provided0 sites60 target enrollmentStarted: April 25, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- 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
Exclusion Criteria
- •- 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.
Investigators
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