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Completed

NCT Number: NCT00144248

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

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Digestive System Diseases Genital Diseases Hepatic Insufficiency Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hopital de l'Hotel Dieu, Lyon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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..

Treatment and study plan

Nevirapine

Drug

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

    Time frame: Up to 4 hours

Secondary outcomes

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

    Time frame: Up to 14 hours

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
First posted
Sep 5, 2005
Registry last updated
Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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