TBTC Study 25: Study of the Tolerability of Higher Doses of Rifapentine in the Treatment of Tuberculosis
- Conditions
- Tuberculosis
- Registration Number
- NCT00023426
- Lead Sponsor
- Centers for Disease Control and Prevention
- Brief Summary
Randomized, double-blind study of the tolerability of three different doses of rifapentine
- Detailed Description
Prospective, randomized, double-blinded, comparative study. Patients are randomized at the completion of induction phase therapy. Sample-size is 50 HIV-seronegative patients with culture-positive, drug susceptible TB in each treatment arm. The first 75 patients will be randomized 2:1 to 900 mg:600 mg rifapentine. The second 75 patients will be randomized 2:1 to 1200 mg:600 mg rifapentine. The DSMB will review tolerability and safety data on the first 21 patients enrolled (at the 900 mg and 600 mg doses) and approve proceeding to enrollment at the 1200 mg dose.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Proportion of patients who fail to complete therapy in each of the dosing groups
- Secondary Outcome Measures
Name Time Method 1. Rate of serious adverse events in each of the dosing groups 2. Rate of total adverse events in each of the groups 3. Rate of relapse in patients with positive sputum culture at 2 months, in each of the groups
Trial Locations
- Locations (23)
Thomas Street Clinic
🇺🇸Houston, Texas, United States
New York University School of Medicine
🇺🇸New York, New York, 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
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Nashville VA Medical Center
🇺🇸Nashville, Tennessee, 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
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Denver Department of Public Health and Hospitals
🇺🇸Denver, Colorado, United States
Montreal Chest Institute McGill University
🇨🇦Montreal, Quebec, Canada
University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
LA County/USC Medical Center
🇺🇸Los Angeles, California, United States
Central Arkansas Veterans Health System
🇺🇸Little Rock, Arkansas, 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
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
University of North Texas Health Science Center
🇺🇸Fort Worth, Texas, United States