- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00023361
TBTC Study 23: Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen
September 1, 2005 updated by: Centers for Disease Control and Prevention
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).
Study Overview
Study Type
Interventional
Enrollment
215
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, Canada V5Z 4R4
- University of British Columbia
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Manitoba
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Winnipeg, Manitoba, Canada, CANADA R3A 1R8
- University of Manitoba
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Quebec
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Montreal, Quebec, Canada, H2X 2P4Pq Canada
- Montreal Chest Institute McGill University
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Arkansas
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Little Rock, Arkansas, United States, 72205
- Central Arkansas Veterans Health System
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California
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Los Angeles, California, United States, 90033
- LA County/USC Medical Center
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San Francisco, California, United States, 94110
- University of California, San Francisco
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Colorado
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Denver, Colorado, United States, 80204
- Denver Department of Public Health and Hospitals
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District of Columbia
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Washington, District of Columbia, United States, 20422
- Washington, D.C. VAMC
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Illinois
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Chicago, Illinois, United States, 60611
- Chicago VA Medical Center (Lakeside)
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Hines, Illinois, United States, 60141
- Hines VA Medical Center
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Maryland
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Baltimore, Maryland, United States, 21287-0003
- Johns Hopkins University School of Medicine
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston Medical Center
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New Jersey
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Newark, New Jersey, United States, 07107-3001
- New Jersey Medical School
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New York
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New York, New York, United States, 10016
- New York University School of Medicine
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New York, New York, United States, 10037
- Harlem Hospital Center
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New York, New York, United States, 10032
- Columbia University/Presbyterian Medical Center
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North Carolina
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Charlotte, North Carolina, United States, 28203
- Carolinas Medical Center
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Durham, North Carolina, United States, 34222
- Duke University Medical Center
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Tennessee
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Nashville, Tennessee, United States, 37212-2637
- Nashville VA Medical Center
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Texas
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Fort Worth, Texas, United States, 76107-2699
- University of North Texas Health Science Center
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Houston, Texas, United States, 77009
- Thomas Street Clinic
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San Antonio, Texas, United States, 78284
- Audi L. Murphy VA Hospital
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Washington
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Seattle, Washington, United States, 98104
- Seattle King County Health Department
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Rate of confirmed treatment failure and relapse
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Secondary Outcome Measures
Outcome Measure |
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Safety and tolerability
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Response of HIV RNA to TB treatment
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Paradoxical reactions
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: William Burman, MD, Denver Health and Hospitals
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 1999
Study Completion
February 1, 2003
Study Registration Dates
First Submitted
September 6, 2001
First Submitted That Met QC Criteria
September 8, 2001
First Posted (Estimate)
September 10, 2001
Study Record Updates
Last Update Posted (Estimate)
September 5, 2005
Last Update Submitted That Met QC Criteria
September 1, 2005
Last Verified
September 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDC-NCHSTP-2174
- TBTC STUDY 23
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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