TBTC Study 23C: Pharmacokinetics of Intermittent Rifabutin and Isoniazid With Daily Efavirenz
- Conditions
- HIV InfectionsTuberculosis
- Registration Number
- NCT00023413
- Lead Sponsor
- Centers for Disease Control and Prevention
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Compare PK of rifabutin 600mg twice weekly with efavirenz 600mg daily to PK of rifabutin 300mg twice weekly without efavirenz
- Secondary Outcome Measures
Name Time Method *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
Trial Locations
- Locations (23)
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, 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
Scroll for more (13 remaining)Central Arkansas Veterans Health System🇺🇸Little Rock, Arkansas, United States