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

Primary Purpose

HIV Infections, Hepatic Insufficiency

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
nevirapine
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION 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. 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. 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 Current (within the past 4 weeks) HIV antiviral therapy with other NNRTI's. Concurrent use (within the past 7 days) of any of the following: Systemic azole antifungal agents (fluconazole, itraconazole, ketoconazole, etc.) Clarithromycin Rifampin St John's Wort Inability to provide a blood sample. Patients who have evidence for hepatic or other encephalopathy above Grade 1 Patients with renal failure who require dialysis. Pregnant and/or breast feeding women..

Sites / Locations

  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • California Pacific Medical Center
  • Albany Medical College, MC 142
  • Boehringer Ingelheim Investigational Site
  • Hopital de l'Hotel Dieu
  • Hopital Pitie Salpetriere
  • Hospital Clinico y Provincial de Barcelona - HIV

Outcomes

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.

Full Information

First Posted
September 2, 2005
Last Updated
December 27, 2017
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00144248
Brief Title
A Pharmacokinetic Study to Assess Nevirapine [Viramune] Levels in HIV Infected Patients With Impaired Hepatic Functions
Official Title
A Pharmacokinetic Study to Assess Nevirapine Levels in HIV-infected Patients With Impaired Hepatic Function
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Hepatic Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
nevirapine
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Plasma levels of nevirapine metabolites of all patients and Child-Pugh scores among patients with cirrhosis.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION 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. 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. 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 Current (within the past 4 weeks) HIV antiviral therapy with other NNRTI's. Concurrent use (within the past 7 days) of any of the following: Systemic azole antifungal agents (fluconazole, itraconazole, ketoconazole, etc.) Clarithromycin Rifampin St John's Wort Inability to provide a blood sample. Patients who have evidence for hepatic or other encephalopathy above Grade 1 Patients with renal failure who require dialysis. Pregnant and/or breast feeding women..
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
Boehringer Ingelheim Investigational Site
City
Bakersfield
State/Province
California
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
San Francisco
State/Province
California
Country
United States
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
Country
United States
Facility Name
Albany Medical College, MC 142
City
Albany
State/Province
New York
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Providence
State/Province
Rhode Island
Country
United States
Facility Name
Hopital de l'Hotel Dieu
City
Lyon cedex 02
Country
France
Facility Name
Hopital Pitie Salpetriere
City
Paris
Country
France
Facility Name
Hospital Clinico y Provincial de Barcelona - HIV
City
Barcelona
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1100/1100.1448_U06-3702.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1100/1100.1448_literature.pdf
Description
Related Info
URL
https://www.ncbi.nlm.nih.gov/pubmed/19620337
Description
Related Info

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

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