TBTC Study 23A: Pharmacokinetics of Intermittent Isoniazid and Rifabutin in HIV-TB
Completed · Phase 2/Phase 3
Conditions studied: HIV Infections, Tuberculosis
In brief
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.
Key facts
- Study ID
- NCT00023348
- Run by
- Centers for Disease Control and Prevention
- People needed
- 150
- Starts
- 1999-07-01
- Expected to finish
- 2002-11-01
- Last updated by the study team
- 2005-09-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
- New York University School of Medicine — New York, New York, United States
- Columbia University/Presbyterian Medical Center — New York, New York, United States
- Harlem Hospital Center — New York, New York, United States
- Carolinas Medical Center — Charlotte, North Carolina, 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
- Thomas Street Clinic — Houston, Texas, United States
- Audi L. Murphy VA Hospital — San Antonio, Texas, United States
- Seattle King County Health Department — Seattle, Washington, United States
- University of British Columbia — Vancouver, British Columbia, Canada
- University of Manitoba — Winnipeg, Manitoba, Canada
- Montreal Chest Institute McGill University — Montreal, Quebec, Canada
Full record on ClinicalTrials.gov
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