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Clinical Trials/NCT00144248
NCT00144248
Completed
Phase 4

A Pharmacokinetic Study to Assess Nevirapine Levels in HIV-infected Patients With Impaired Hepatic Function

Boehringer Ingelheim6 sites in 3 countries51 target enrollmentJune 25, 2004
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ConditionsHIV InfectionsHepatic Insufficiency
Drugsnevirapine

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
HIV Infections
Sponsor
Boehringer Ingelheim
Enrollment
51
Locations
6
Primary Endpoint
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
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 25, 2004
End Date
June 1, 2006
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: Up to 4 hours

Secondary Outcomes

  • Plasma levels of nevirapine metabolites of all patients and Child-Pugh scores among patients with cirrhosis.(Up to 14 hours)

Study Sites (6)

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