Clinical trial NCT00144248: A Pharmacokinetic Study to Assess Nevirapine [Viramune] Levels in HIV Infected Patients With Impaired Hepatic Functions
Official title: A Pharmacokinetic Study to Assess Nevirapine Levels in HIV-infected Patients With Impaired Hepatic Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Hepatic Insufficiency
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: INCLUSION

1. Male or female subjects \>=18 years of age with HIV-1 infection and chronic liver 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 collection.

   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 nevirapi0 mg twice daily for a minimum of 14 days prior to trough collection.
3. Participants must have uoxylin 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 pathologically confirm the presence of cirrhosis. The presence of cirrhosis must be documented 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, etc.)
   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..

Primary outcomes:
measure: 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
timeFrame: Up to 4 hours
Secondary outcomes:
measure: Plasma levels of nevirapine metabolites of all patients and Child-Pugh scores among patients with cirrhosis.
timeFrame: Up to 14 hours
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: San Francisco
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Albany
country: United States
facility: Albany Medical College, MC 142
state: New York
city: Providence
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Rhode Island
city: Lyon cedex 02
country: France
facility: Hopital de l'Hotel Dieu
city: Paris
country: France
facility: Hopital Pitie Salpetriere
city: Barcelona
country: Spain
facility: Hospital Clinico y Provincial de Barcelona - HIV
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References: