NCT00162097

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infections
• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	efavirenz containing antiretroviral regimen	Capsule or Tablet, Oral, once daily for 2 days
DRUG	efavirenz containing antiretroviral regimen	Capsule or Tablet, Oral, once daily for 2 days
DRUG	efavirenz containing antiretroviral regimen	Capsule or Tablet, Oral, once daily for 2 days
DRUG	efavirenz containing antiretroviral regimen	Capsule or Tablet, Oral, once daily for 2 days

Timeline

• Start date: 2004-11-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2005-09-13
• Last updated: 2010-09-14
• Results posted: 2010-08-25

Locations

4 sites across 2 countries: United States, Italy