TBTC Study 23: Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen
2 other identifiers
interventional
215
2 countries
23
Brief Summary
Primary objective: To determine the rate of confirmed treatment failure and relapse with an intermittent rifabutin-based regimen for the treatment of isoniazid and rifamycin-susceptible HIV-related tuberculosis (TB).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv-infections
Started Feb 1999
Longer than P75 for not_applicable 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
February 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
February 1, 2003
CompletedSeptember 5, 2005
September 1, 2005
September 6, 2001
September 1, 2005
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of confirmed treatment failure and relapse
Secondary Outcomes (3)
Safety and tolerability
Response of HIV RNA to TB treatment
Paradoxical reactions
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of pulmonary \&/or extrapulmonary TB confirmed by a positive culture and susceptibility to rifampin. Patients having isoniazid or pyrazinamide (PZA)-resistant isolates are eligible to continue in the study on a modified regimen
- Evidence of HIV infection confirmed by a positive serologic test (ELISA and Western Blot).
- Absolute neutrophil count \>500/mm3 (use of colony stimulating factors, filgrastim, or sargramostim is allowed)
- \> 18 years of age
- Willingness to practice effective contraception if applicable
- Signed informed consent
You may not qualify if:
- Pregnancy or breastfeeding
- AST \> 10 times the upper limit of normal
- Bilirubin \> 3.0 times the upper limit of normal
- Creatinine \> 3.0 times the upper limit of normal
- Intolerance to any of the study drugs except isoniazid or pyrazinamide
- Concomitant disorder that is contraindication to the use of the study drugs
- More than 28 days of treatment for active tuberculosis within the 6 months prior to this course of therapy
- Bone/joint tuberculosis or silicotuberculosis
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: 15844071BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
William Burman, MD
Denver Health and Hospitals
Study Design
- Study Type
- interventional
- Phase
- not applicable
- 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
February 1, 1999
Study Completion
February 1, 2003
Last Updated
September 5, 2005
Record last verified: 2005-09