TBTC Study 23A: Pharmacokinetics of Intermittent Isoniazid and Rifabutin in HIV-TB
2 other identifiers
interventional
150
2 countries
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hiv-infections
Started Jul 1999
Typical duration for phase_2 hiv-infections
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 1999
CompletedFirst Submitted
Initial submission to the registry
September 6, 2001
CompletedFirst Posted
Study publicly available on registry
September 10, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2002
CompletedSeptember 13, 2005
September 1, 2005
September 6, 2001
September 9, 2005
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the proportion of patients with HIV-related tuberculosis who have abnormal pharmacokinetics of isoniazid and rifabutin.
Secondary Outcomes (4)
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.
Interventions
Eligibility Criteria
You may qualify if:
- Patient enrolled in TBTC Study 23
- Informed consent
You may not qualify if:
- \. Severe anemia (Hct \<25%)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Central Arkansas Veterans Health System
Little Rock, Arkansas, 72205, United States
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 D.C., District of Columbia, 20422, United States
Chicago VA Medical Center (Lakeside)
Chicago, Illinois, 60611, United States
Hines VA Medical Center
Hines, Illinois, 60141, United States
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
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Duke University Medical Center
Durham, North Carolina, 34222, United States
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
University of British Columbia
Vancouver, British Columbia, Canada V5Z 4R4, Canada
University of Manitoba
Winnipeg, Manitoba, CANADA R3A 1R8, Canada
Montreal Chest Institute McGill University
Montreal, Quebec, H2X 2P4Pq Canada, Canada
Related Publications (1)
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.
PMID: 15844071RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Weiner, MD
Audie L. Murphy VA Medical Center, San Antonio TX
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
Study Record Dates
First Submitted
September 6, 2001
First Posted
September 10, 2001
Study Start
July 1, 1999
Study Completion
November 1, 2002
Last Updated
September 13, 2005
Record last verified: 2005-09