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Pharmacokinetics of Efavirenz in HIV-1 Infected Subjects With Hepatic Impairment | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT00162097•Bristol-Myers Squibb

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (4)

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

Key Dates

Start Date

November 1, 2004

Primary Completion Date

March 1, 2008

Completion Date

March 1, 2008

Last Updated

September 14, 2010

Enrollment

ACTUAL participants

Conditions

HIV InfectionsHepatic Impairment

Interventions

efavirenz containing antiretroviral regimen

DRUG

efavirenz containing antiretroviral regimen

DRUG

efavirenz containing antiretroviral regimen

DRUG

efavirenz containing antiretroviral regimen

DRUG

Skeletal Muscle Energetics and Fatiguability in Older Individuals

NCT04142047

HIVHIV Infections

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A Study to Evaluate EDG-7500 in Adults With Hepatic Impairment

NCT07324616

Hepatic Impairment (HI)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 14, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Skeletal Muscle Energetics and Fatiguability in Older Individuals

A Study to Evaluate EDG-7500 in Adults With Hepatic Impairment

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

Clinic vs Clinic+Community Outreach HPV Self-Collection to Increase Cervical Screening in Women With HIV

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