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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00144248
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : December 28, 2017
Information provided by:
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
HIV Infections Hepatic Insufficiency Drug: nevirapine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pharmacokinetic Study to Assess Nevirapine Levels in HIV-infected Patients With Impaired Hepatic Function
Study Start Date : May 2004
Actual Primary Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Nevirapine

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Plasma levels of nevirapine metabolites of all patients and Child-Pugh scores among patients with cirrhosis.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  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.


  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..

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00144248

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

Additional Information: Identifier: NCT00144248     History of Changes
Other Study ID Numbers: 1100.1448
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: December 28, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
HIV Infections
Hepatic Insufficiency
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Liver Diseases
Digestive System Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers