A Pharmacokinetic Study to Assess Nevirapine [Viramune] Levels in HIV Infected Patients With Impaired Hepatic Functions

HIV Infections Clinical Trial

Official title:

A Pharmacokinetic Study to Assess Nevirapine Levels in HIV-infected Patients With Impaired Hepatic Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00144248
• Other study ID #: 1100.1448
• Status: Completed
• Phase: Phase 4
• Start date: June 25, 2004

Study information

• Verified date: November 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. primary completion date: June 1, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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..

Related Conditions & MeSH terms

• Hepatic Insufficiency
• HIV Infections
• Liver Failure

Intervention

Drug:
• nevirapine

Locations

Country	Name	City	State
France	Hopital de l'Hotel Dieu	Lyon cedex 02
France	Hopital Pitie Salpetriere	Paris
Spain	Hospital Clinico y Provincial de Barcelona - HIV	Barcelona
United States	Albany Medical College, MC 142	Albany	New York
United States	Boehringer Ingelheim Investigational Site	Bakersfield	California
United States	Boehringer Ingelheim Investigational Site	Providence	Rhode Island
United States	Boehringer Ingelheim Investigational Site	San Francisco	California
United States	California Pacific Medical Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Plasma levels of nevirapine metabolites of all patients and Child-Pugh scores among patients with cirrhosis.		Up to 14 hours

External Links

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