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COMPLETED
NCT00694629
PHASE2

TBTC Study 29: Rifapentine During Intensive Phase Tuberculosis (TB) Treatment

Sponsor: Centers for Disease Control and Prevention

View on ClinicalTrials.gov

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

Interventions

DRUG

rifapentine

tablet, 10 mg/kg, daily, 8 weeks

DRUG

rifapentine 10 mg/kg

tablet, 10 mg/kg, daily, 8 weeks

DRUG

rifapentine 15 mg/kg

tablet, 15 mg/kg, daily, 8 weeks

DRUG

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