TBTC Study 23A: Pharmacokinetics of Intermittent Isoniazid and Rifabutin in HIV-TB
NCT ID: NCT00023348
Last Updated: 2005-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
150 participants
INTERVENTIONAL
1999-07-31
2002-11-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Isoniazid
Rifabutin
Eligibility Criteria
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Inclusion Criteria
2. Informed consent
Exclusion:
1\. Severe anemia (Hct \<25%)
18 Years
ALL
No
Sponsors
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US Department of Veterans Affairs
FED
Centers for Disease Control and Prevention
FED
Principal Investigators
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Marc Weiner, MD
Role: PRINCIPAL_INVESTIGATOR
Audie L. Murphy VA Medical Center, San Antonio TX
Locations
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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
Countries
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References
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Weiner M, Benator D, Burman W, Peloquin CA, Khan A, Vernon A, Jones B, Silva-Trigo C, Zhao Z, Hodge T; Tuberculosis Trials Consortium. Association between acquired rifamycin resistance and the pharmacokinetics of rifabutin and isoniazid among patients with HIV and tuberculosis. Clin Infect Dis. 2005 May 15;40(10):1481-91. doi: 10.1086/429321. Epub 2005 Apr 14.
Related Links
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(Click here for more information about the Tuberculosis Trials Consortium (TBTC)
Other Identifiers
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23A
Identifier Type: -
Identifier Source: secondary_id
CDC-NCHSTP-2173
Identifier Type: -
Identifier Source: org_study_id