MedTrace Logo

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

NCT00162097 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2010-09-14

Study results available
· View outcomes & findings →

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

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

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • United States
  • Italy

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00162097 on ClinicalTrials.gov