Pharmacokinetics of Efavirenz in HIV-1 Infected Subjects With Hepatic Impairment

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study was to assess the steady-state pharmacokinetics (PK) of efavirenz (EFV) in human immunodeficiency virus type 1 (HIV-1) infected subjects on stable antiretroviral regimens containing EFV, and having selected degrees of hepatic impairment or normal hepatic function.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Anti-Retroviral Agents; Efavirenz

Criteria

Inclusion Criteria:

• HIV-1 infection with or without Hepatitis B or C infection

• Stable antiretroviral regimen containing efavirenz and nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) for at least 1 month

• Mild, moderate or severe hepatic impairment with hepatic cirrhosis

Exclusion Criteria:

• Acute flare of hepatitis

• Positive pregnancy test for a female

• Significant acute medical illness in past 2 months

• Use of agents known to significantly affect liver metabolism

• Change in medications to treat a chronic disease in the past 2 months