Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Pharmacokinetic Study to Assess Nevirapine [Viramune] Levels in HIV Infected Patients With Impaired Hepatic Functions
This study has been completed.
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00144248
  Purpose

To evaluate the correlation between the degree of hepatic impairment based on liver biopsy score (mild, moderate, severe) and plasma levels of nevirapine [Viramune] and its metabolites


Condition Intervention Phase
HIV Infections
Hepatic Insufficiency
Drug: nevirapine
Phase IV

MedlinePlus related topics: AIDS
Drug Information available for: Nevirapine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Historical Control, Parallel Assignment
Official Title: Evaluation of Nevirapine Levels in Hepatically Impaired Patients

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

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.

Estimated Enrollment: 60
Estimated Study Completion Date: November 2006
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00144248

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

Related Info  This link exits the ClinicalTrials.gov site

Study ID Numbers: 1100.1448
Study First Received: September 2, 2005
Last Updated: November 28, 2008
ClinicalTrials.gov Identifier: NCT00144248  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Virus Diseases
Nevirapine
Liver Diseases
Sexually Transmitted Diseases, Viral
Digestive System Diseases
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes
Hepatic Insufficiency

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Anti-HIV Agents
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009