TBTC Study 23A: Pharmacokinetics of Intermittent Isoniazid and Rifabutin in HIV-TB
Status:
Completed
Trial end date:
2002-11-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborators:
US Department of Veterans Affairs VA Office of Research and Development