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

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Trial phase: 
Phase I
Recruitment status: 
Active, not recruiting

The purpose of this clinical research is to learn if Efavirenz PK is different in HIV-1 infected subjects with hepatic (liver) impairment. Subjects will already be on Efavirenz for HIV-1 infection. Goal is to observe pharmacokinetics of Efavirenz in this patient population with HIV-1 infection and various degrees of hepatic impairment.

Background information
Trial ID: 
NCT00162097
Other unique IDs: 
AI266-917
Official title: 

Pharmacokinetics of Efavirenz During Treatment of HIV-1 Infected Subjects With Hepatic Impairment.

Detailed description: 

 

Number to be enrolled: 
24 patients
Clinical information
Age groups: 
Adult
Senior
Gender: 
Both
Eligibility 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

Study design: 
Treatment
Open Label
Parallel Assignment
Non-Randomized
Uncontrolled
Pharmacokinetics Study
Interventions: 
efavirenz containing antiretroviral regimen
Study arms: 
Experimental: 600 mg
Experimental: 600 mg or reduced dosage
Active Comparator: 600 mg
Conditions treated: 
HIV Infections
Hepatic Impairment
Funding
Funding types: 
INDUSTRY
Sponsor: 
Bristol-Myers Squibb
Dates
Date the data was first received: 
Fri, 2005-09-09
Trial start date: 
Mon, 2004-11-01
Trial completion date: 
Sun, 2009-02-01
Trial last updated: 
Wed, 2009-05-20