Status:
COMPLETED
Pharmacokinetics of Efavirenz in HIV-1 Infected Subjects With Hepatic Impairment
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
HIV Infections
Hepatic Impairment
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 cont...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00162097
Start Date
November 1 2004
End Date
March 1 2008
Last Update
September 14 2010
Active Locations (4)
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1
Johns Hopkins University School Of Medicine
Baltimore, Maryland, United States, 21287
2
Uthscsa
San Antonio, Texas, United States, 78229
3
Virginia Commonwealth University Health Systems
Richmond, Virginia, United States, 23298
4
Local Institution
Milan, Italy, 20127