TBTC Study 22: Efficacy of Once-Weekly Rifapentine and Isoniazid in Treatment of Tuberculosis
- Conditions
- Pulmonary Tuberculosis
- Registration Number
- NCT00023335
- Lead Sponsor
- Centers for Disease Control and Prevention
- Brief Summary
Primary Objective: To compare, at the completion of the follow-up phase, the clinical and bacteriologic relapse rates associated with the two study regimens.
Secondary Objectives:
To compare the clinical and bacteriologic failure rates of the two study regimens at the completion of the study phase therapy.
To compare the clinical and bacteriologic response rates for the two study regimens among patients who began study phase therapy with signs and symptoms of tuberculosis or cultures positive for M. tuberculosis.
To compare the toxicity associated with the two study regimens by comparing discontinuation rates due to adverse events and occurrence rates of signs and symptoms associated with adverse events during study phase therapy.
To compare mortality rates of the two study regimens. To compare the rates of completion of therapy within 22 weeks for the two study regimens.
To compare the rate of development of drug-resistant tuberculosis in the two study regimens among study patients classified as treatment failures or relapses.
To compare all of the above performance characteristics for the two study regimens in a small subset of HIV seropositive patients.
To compare attitudes and beliefs about participation in this study between patients who complete study therapy and those who fail to complete study therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
LA County/USC Medical Center
🇺🇸Los Angeles, California, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Chicago VA Medical Center (Lakeside)
🇺🇸Chicago, Illinois, United States
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Nashville VA Medical Center
🇺🇸Nashville, Tennessee, 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 Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Central Arkansas Veterans Health System
🇺🇸Little Rock, Arkansas, United States
Denver Department of Public Health and Hospitals
🇺🇸Denver, Colorado, United States
Washington, D.C. VAMC
🇺🇸Washington, District of Columbia, United States
Hines VA Medical Center
🇺🇸Hines, Illinois, United States
New Jersey Medical School
🇺🇸Newark, New Jersey, United States
New York University School of Medicine
🇺🇸New York, New York, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Columbia University/Presbyterian Medical Center
🇺🇸New York, New York, United States
Harlem Hospital Center
🇺🇸New York, New York, United States
University of North Texas Health Science Center
🇺🇸Fort Worth, Texas, United States
University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Montreal Chest Institute McGill University
🇨🇦Montreal, Quebec, Canada