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

September 2, 2005
November 4, 2013
May 2004
June 2006   (final data collection date for primary outcome 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
1 the degree of hepatic impairment, 2 steady state nevirapine clearance, and 3 the increase in estimated clearance when trough is supplemented by plasma levels measured one, two and four hours after nevirapine administratio
Complete list of historical versions of study NCT00144248 on ClinicalTrials.gov Archive Site
Plasma levels of nevirapine metabolites of all patients and Child-Pugh scores among patients with cirrhosis.
  • (1)plasma levels of nevirapine metabolites of all patients; and
  • (2) Child-Pugh scores among patients with cirrhosis.
Not Provided
Not Provided
 
A Pharmacokinetic Study to Assess Nevirapine [Viramune] Levels in HIV Infected Patients With Impaired Hepatic Functions
A Pharmacokinetic Study to Assess Nevirapine Levels in HIV-infected Patients With Impaired Hepatic Function

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Hepatic Insufficiency
Drug: nevirapine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
Not Provided
June 2006   (final data collection date for primary outcome measure)

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..
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Spain
 
NCT00144248
1100.1448
Not Provided
Not Provided
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
Boehringer Ingelheim
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP