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

Completed · Phase 1

Conditions studied: HIV Infections, Hepatic Impairment

In brief

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.

Key facts

Study ID

NCT00162097

Run by

Bristol-Myers Squibb

People needed

21

Starts

2004-11-01

Expected to finish

2008-03-01

Last updated by the study team

2010-09-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Johns Hopkins University School Of Medicine — Baltimore, Maryland, United States
• Uthscsa — San Antonio, Texas, United States
• Virginia Commonwealth University Health Systems — Richmond, Virginia, United States
• Local Institution — Milan, Italy

Full record on ClinicalTrials.gov

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