TBTC Study 23A: Pharmacokinetics of Intermittent Isoniazid and Rifabutin in HIV-TB
Information source: Centers for Disease Control and Prevention
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; Tuberculosis
Intervention: Isoniazid (Drug); Rifabutin (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Centers for Disease Control and Prevention Official(s) and/or principal investigator(s):
Marc Weiner, MD, Principal Investigator, Affiliation: Audie L. Murphy VA Medical Center, San Antonio TX
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.
Clinical Details
Official title: TBTC Study 23A: Pharmacokinetics of Intermittent Isoniazid and Rifabutin in USPHS Study 23: Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen
Study design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Pharmacokinetics Study
Primary outcome: To determine the proportion of patients with HIV-related tuberculosis who have abnormal pharmacokinetics of isoniazid and rifabutin.
Secondary outcome: 1) To determine risk factors for abnormal pharmacokinetics of isoniazid and rifabutin2) 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).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion:
1. Patient enrolled in TBTC Study 23
2. Informed consent
Exclusion:
1. Severe anemia (Hct <25%)
Locations and Contacts
Central Arkansas Veterans Health System, Little Rock, Arkansas 72205, United States
University of British Columbia, Vancouver, British Columbia Canada V5Z 4R4, Canada
LA County/USC Medical Center, Los Angeles, California 90033, United States
University of California, San Francisco, San Francisco, California 94110, United States
Denver Department of Public Health and Hospitals, Denver, Colorado 80204, United States
Washington, D.C. VAMC, Washington, District of Columbia 20422, United States
Hines VA Medical Center, Hines, Illinois 60141, United States
Chicago VA Medical Center (Lakeside), Chicago, Illinois 60611, United States
University of Manitoba, Winnipeg, Manitoba CANADA R3A 1R8, Canada
Johns Hopkins University School of Medicine, Baltimore, Maryland 21287-0003, United States
Boston Medical Center, Boston, Massachusetts 02118, United States
New Jersey Medical School, Newark, New Jersey 07107-3001, United States
New York University School of Medicine, New York, New York 10016, United States
Columbia University/Presbyterian Medical Center, New York, New York 10032, United States
Harlem Hospital Center, New York, New York 10037, United States
Duke University Medical Center, Durham, North Carolina 34222, United States
Carolinas Medical Center, Charlotte, North Carolina 28203, United States
Montreal Chest Institute McGill University, Montreal, Quebec H2X 2P4Pq Canada, Canada
Nashville VA Medical Center, Nashville, Tennessee 37212-2637, United States
University of North Texas Health Science Center, Fort Worth, Texas 76107-2699, United States
Thomas Street Clinic, Houston, Texas 77009, United States
Audi L. Murphy VA Hospital, San Antonio, Texas 78284, United States
Seattle King County Health Department, Seattle, Washington 98104, United States
Additional Information
(Click here for more information about the Tuberculosis Trials Consortium (TBTC)
Starting date: July 1999
Ending date: November 2002
Last updated: September 9, 2005
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