NCT00144248

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_4 hiv-infections

Geographic Reach
3 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 25, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

1.9 years

First QC Date

September 2, 2005

Last Update Submit

November 30, 2023

Conditions

HIV InfectionsHepatic Insufficiency

Outcome Measures

Primary Outcomes (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

    Up to 4 hours

Secondary Outcomes (1)

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

    Up to 14 hours

Interventions

nevirapineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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..

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Boehringer Ingelheim Investigational Site

Bakersfield, California, United States

Location

Boehringer Ingelheim Investigational Site

San Francisco, California, United States

Location

California Pacific Medical Center

San Francisco, California, United States

Location

Albany Medical College, MC 142

Albany, New York, United States

Location

Boehringer Ingelheim Investigational Site

Providence, Rhode Island, United States

Location

Hopital de l'Hotel Dieu

Lyon, France

Location

Hopital Pitie Salpetriere

Paris, France

Location

Hospital Clinico y Provincial de Barcelona - HIV

Barcelona, Spain

Location

Related Links

MeSH Terms

Conditions

HIV InfectionsHepatic Insufficiency

Interventions

Nevirapine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Boehringer Ingelheim Study Coordinator

    Boehringer Ingelheim

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 5, 2005

Study Start

June 25, 2004

Primary Completion

June 1, 2006

Last Updated

December 1, 2023

Record last verified: 2023-11

Locations

FR(2)US(5)ES(1)