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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00144248
Enrollment
51
Registered
2005-09-05
Start date
2004-06-25
Completion date
Unknown
Last updated
2023-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Insufficiency, HIV Infections

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.

Interventions

DRUGnevirapine

Sponsors

Boehringer Ingelheim
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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..

Design outcomes

Primary

MeasureTime frame
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 administrationUp to 4 hours

Secondary

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

Countries

France, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026