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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00144248
First received: September 2, 2005
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
HIV Infections
Hepatic Insufficiency
Drug: nevirapine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pharmacokinetic Study to Assess Nevirapine Levels in HIV-infected Patients With Impaired Hepatic Function

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

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

Enrollment: 51
Study Start Date: May 2004
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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..
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144248

Locations
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
France
Hopital de l'Hotel Dieu
Lyon cedex 02, France
Hopital Pitie Salpetriere
Paris, France
Spain
Hospital Clinico y Provincial de Barcelona - HIV
Barcelona, Spain
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00144248     History of Changes
Other Study ID Numbers: 1100.1448
Study First Received: September 2, 2005
Last Updated: November 4, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Hepatic Insufficiency
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Liver Diseases
Digestive System Diseases
Nevirapine
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014