TBTC Study 23A: Pharmacokinetics of Intermittent Isoniazid and Rifabutin in HIV-TB
- Conditions
- HIV InfectionsTuberculosis
- Registration Number
- NCT00023348
- Lead Sponsor
- Centers for Disease Control and Prevention
- Brief Summary
Primary Objectives:
1) To determine the proportion of patients with HIV-related tuberculosis who have abnormal pharmacokinetic parameters for isoniazid and rifabutin.
Secondary Objectives:
1. To determine risk factors for abnormal pharmacokinetic parameters for isoniazid and rifabutin.
2. To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the occurrence of toxicity attributed to antituberculous therapy.
3. To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the efficacy of TB therapy.
4. To define and correlate phenotypic INH acetylator status with the results of genotypic acetylator data obtained in the parent trial.
- Detailed Description
This study will seek to enroll every eligible patient enrolled in TBTC Study 23. Consenting patients will be asked to undergo measurements of isoniazid (if receiving), rifabutin and 25-OH desacetyl rifabutin levels at a time point in the study when steady state rifabutin levels are expected to have been achieved (at least two weeks following the start of rifabutin).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To determine the proportion of patients with HIV-related tuberculosis who have abnormal pharmacokinetics of isoniazid and rifabutin.
- Secondary Outcome Measures
Name Time Method 1) To determine risk factors for abnormal pharmacokinetics of isoniazid and rifabutin 2) To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the occurrence of toxicity attributed to antituberculous therapy. 3) To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the efficacy of TB therapy. 4) To define and correlate phenotypic INH acetylator status with the results of genotypic acetylator data obtained in the parent trial.
Trial Locations
- Locations (23)
Denver Department of Public Health and Hospitals
🇺🇸Denver, Colorado, United States
Hines VA Medical Center
🇺🇸Hines, Illinois, United States
University of Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Montreal Chest Institute McGill University
🇨🇦Montreal, Quebec, Canada
University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Chicago VA Medical Center (Lakeside)
🇺🇸Chicago, Illinois, United States
LA County/USC Medical Center
🇺🇸Los Angeles, California, United States
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Thomas Street Clinic
🇺🇸Houston, Texas, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Seattle King County Health Department
🇺🇸Seattle, Washington, United States
Audi L. Murphy VA Hospital
🇺🇸San Antonio, Texas, United States
Central Arkansas Veterans Health System
🇺🇸Little Rock, Arkansas, United States
Washington, D.C. VAMC
🇺🇸Washington, District of Columbia, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
New Jersey Medical School
🇺🇸Newark, New Jersey, United States
New York University School of Medicine
🇺🇸New York, New York, United States
Harlem Hospital Center
🇺🇸New York, New York, United States
Columbia University/Presbyterian Medical Center
🇺🇸New York, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Nashville VA Medical Center
🇺🇸Nashville, Tennessee, United States
University of North Texas Health Science Center
🇺🇸Fort Worth, Texas, United States