The aim of this trial is to study the efavirenz-rifabutin interaction. Thus, this trial will enroll patients with HIV and tuberculosis co-infections who are receiving a rifabutin-based regimen and who plan to begin an antiretroviral regimen containing efavirenz dosed at 600 mg daily. Enrollment in TB Trials Consortium Study 23 is not a requirement for participation in this study. Primary Objective: To compare the pharmacokinetics of rifabutin at 600 mg twice a week in combination with efavirenz 600 mg daily to the pharmacokinetics of rifabutin 300 mg twice a week without efavirenz.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Central Arkansas Veterans Health System
Little Rock, Arkansas, United States
LA County/USC Medical Center
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Denver Department of Public Health and Hospitals
Denver, Colorado, United States
Washington, D.C. VAMC
Washington D.C., District of Columbia, United States
Chicago VA Medical Center (Lakeside)
Chicago, Illinois, United States
Hines VA Medical Center
Hines, Illinois, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
New Jersey Medical School
Newark, New Jersey, United States
...and 13 more locations
Compare PK of rifabutin 600mg twice weekly with efavirenz 600mg daily to PK of rifabutin 300mg twice weekly without efavirenz
*Describe PK of rifabutin 600mg twice weekly in combination with efavirenz 600mg daily with 2 NRTI's
*Describe PK of efavirenz in this regimen
*Assess safety of concomitant rifabutin and efavirenz in HIV-TB
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