A Pharmacokinetic Study to Assess Nevirapine [Viramune] Levels in HIV Infected Patients With Impaired Hepatic Functions
Information source: Boehringer Ingelheim Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; Hepatic Insufficiency
Intervention: nevirapine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Boehringer Ingelheim Pharmaceuticals Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: Boehringer Ingelheim Pharmaceuticals
Summary
To evaluate the correlation between the degree of hepatic impairment based on liver biopsy
score (mi ld, moderate, severe) and plasma levels of nevirapine [Viramune] and its
metobolites
Clinical Details
Official title: Evaluation of Nevirapine Levels in Hepatically Impaired Patients
Study design: Treatment, Randomized, Open Label, Historical Control, Parallel Assignment
Primary outcome: 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 administratio
Secondary outcome: Plasma levels of nevirapine metabolites of all patients and Child-Pugh scores among patients with cirrhosis.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
INCLUSION
1. Male or female subjects >=18 years of age with HIV-1 infection and chronic li ver
disease as reflected by a documented biopsy with hepatic fibrosis present.
2. a. 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 sample collec tion. b.
Participants receiving nevirapine 400 mg once daily as part of a stable ARV regimen
for a minimum of 6 weeks, who are willing to switch to nevirapine 20 0 mg twice daily
for a minimum of 14 days prior to trough collection.
3. Participants must have undergone a liver biopsy within 24 months prior to enr ollment
and have a pathology report and at least one Hematoxylin and Eosin (H and E) stained
slide and one trichrome stained pathology slide available at the time of enrollment.
There is no time restriction on liver biopsy slides that pathol ogically confirm the
presence of cirrhosis. The presence of cirrhosis must be d ocumented on the liver
biopsy report.
EXCLUSION
1. Current (within the past 4 weeks) HIV antiviral therapy with other NNRTI's.
2. Concurrent use (within the past 7 days) of any of the following:
1. Systemic azole antifungal agents (fluconazole, itraconazole, ketoconazole, et
c.)
2. Clarithromycin
3. Rifampin
4. St John's Wort
3. Inability to provide a blood sample.
4. Patients who have evidence for hepatic or other encephalopathy above Grade 1
5. Patients with renal failure who require dialysis.
6. Pregnant and/or breast feeding women..
Locations and Contacts
Hopital Pitie Salpetriere, Paris, France
Hopital de l'Hotel Dieu, Lyon cedex 02, France
Hospital Clinico y Provincial de Barcelona - HIV, Barcelona, Spain
Boehringer Ingelheim Investigational Site, San Francisco, California, United States
Boehringer Ingelheim Investigational Site, Bakersfield, California, United States
California Pacific Medical Center, San Francisco, California, United States
Albany Medical College, MC 142, Albany, New York, United States
Boehringer Ingelheim Investigational Site, Providence, Rhode Island, United States
Additional Information
Ending date: November 2006
Last updated: April 3, 2008
|
