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TBTC Study 29: Rifapentine During Intensive Phase Tuberculosis (TB) Treatment
Sponsor: Centers for Disease Control and Prevention
Summary
This Phase 2, multicenter, open-label clinical trial evaluated the antimicrobial activity and safety of rifapentine-containing regimens during the intensive phase of pulmonary tuberculosis treatment. Participants were randomized to receive either a standard rifampin-based regimen (RHZE) or a rifapentine-substituted regimen (PHZE). An extension study evaluated higher daily doses of rifapentine (10, 15, and 20 mg/kg). The primary endpoint was sputum culture conversion at 8 weeks. Secondary outcomes included time to culture conversion, safety, and treatment discontinuation.
Official title: TBTC Study 29: Evaluation of a Rifapentine-containing Regimen for Intensive Phase Treatment of Pulmonary Tuberculosis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
334
Start Date
2008-12
Completion Date
2013-12
Last Updated
2026-07-23
Healthy Volunteers
No
Conditions
Interventions
rifapentine
tablet, 10 mg/kg, daily, 8 weeks
rifapentine 10 mg/kg
tablet, 10 mg/kg, daily, 8 weeks
rifapentine 15 mg/kg
tablet, 15 mg/kg, daily, 8 weeks
rifapentine 20 mg/kg
20 mg/kg, daily, 8 weeks
Locations (29)
Central Arkansas Veterans Health System
Little Rock, Arkansas, United States
LA County/USC Medical Center
Los Angeles, California, United States
University of Southern California Medical Center
Los Angeles, California, United States
University of California at San Diego
San Diego, California, United States
University of California, San Francincisco
San Francisco, California, United States
Denver Department of Public Health and Hospitals
Denver, Colorado, United States
Washington DC Veterans Administration Medical Center
Washington D.C., District of Columbia, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Chicago VA Medical Center (Lakeside)
Chicago, Illinois, United States
Northwestern University
Chicago, Illinois, United States
Hines VA Medical Center
Hines, Illinois, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
New Jersey Medical School
Newark, New Jersey, United States
Columbia University/Presbyterian Medical Center
New York, New York, United States
Harlem Hospital, Columbia University
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Nashville VA Medical Center
Nashville, Tennessee, United States
Veterans Administration Tennessee Valley Health Care System
Nashville, Tennessee, United States
University of North Texas Health Science Center
Fort Worth, Texas, United States
Houston Veterans Administration Medical Center
Houston, Texas, United States
Audi L. Murphy VA Hospital
San Antonio, Texas, United States
Seattle King County Health Department
Seattle, Washington, United States
Hopital Universitario Clementino Fraga Filho
Rio de Janeiro, Brazil
University of Manitoba
Winnepeg, Manitoba, Canada
Montreal Chest Institute McGill University
Montreal, Quebec, Canada
Nelson R Mandela School of Medicine
Durban, KwaZulu-Natal, South Africa
Agencia de Salut Publica
Barcelona, Spain
Makerere University Medical School
Kampala, Uganda