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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 9, 2005

Last Updated Date

May 6, 2009

Start Date ^†

November 2004

Current Primary Outcome Measures ^†

To assess steady-state PK of efavirenz in HIV-1 infected subjects on stable antiretroviral regimens containing efavirenz, and having selected degrees of hepatic impairment or normal hepatic function. [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

To assess steady-state PK of efavirenz in HIV-1 infected subjects on stable antiretroviral regimens containing efavirenz, and having selected degrees of hepatic impairment or normal hepatic function.

Change History

Complete list of historical versions of study NCT00162097 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

To assess the safety of efavirenz in HIV-1 infected subjects, with or without hepatic impairment, on stable antiretroviral regimen containing efavirenz. [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^†

To assess the safety of efavirenz in HIV-1 infected subjects, with or without hepatic impairment, on stable antiretroviral regimen containing efavirenz.

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

Brief Summary

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.

Detailed Description

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study

Condition ^†

HIV Infections
Hepatic Impairment

Intervention ^†

Drug: efavirenz containing antiretroviral regimen

Study Arms / Comparison Groups

Experimental: 600 mg
Experimental: 600 mg or reduced dosage
Active Comparator: 600 mg

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Estimated Completion Date

February 2009

Estimated Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Italy, Spain

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00162097

Responsible Party

Study Director, Bristol-Myers Squibb

Secondary IDs ^††

Study Sponsor ^†

Bristol-Myers Squibb

Collaborators ^††

Investigators ^†

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

April 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.