Three Months of Weekly Rifapentine and Isoniazid for M. Tuberculosis Infection

PHASE3CompletedINTERVENTIONAL
Enrollment

8,053

Participants

Timeline

Start Date

June 30, 2001

Primary Completion Date

October 31, 2010

Study Completion Date

September 30, 2013

Conditions
Tuberculosis
Interventions
DRUG

RPT + INH once weekly for 3 months given by DOT

"Rifapentine (RPT) 900 mg once-weekly x 12 doses (3 months) for persons \> 50.0 kg. For persons \< 50.0 kg, the following doses will be given (Weight/Dose): 10.0-14.0 kg / 300 mg; 14.1-25.0 kg / 450 mg; 25.1-32.0 kg / 600 mg; 32.1-50.0 kg / 750 mg.~PLUS~Isoniazid (INH) 15 mg/kg (rounded up to nearest 50 or 100 mg; 900 mg max) once weekly x 12 doses if \> 12 years old. INH 25 mg/kg (round up to nearest 50 or 100 mg; 900 mg max) if 2-11 years old.~Therapy will be given by Directly Observed Therapy (DOT)."

DRUG

Isoniazid (INH) daily for 9 months

Isoniazid (INH) 5 mg/kg (rounded up to nearest 50 or 100 mg; 300 mg max) daily x 270 doses (9 months) For children age 2 - 11, INH 10-15 mg/kg (round up to nearest 50 or 100 mg; 300 mg max) will be given.

Trial Locations (26)

10032

Columbia University/Presbyterian Medical Center, New York

10037

Harlem Hospital Center, New York

20422

Washington, D.C. VAMC, Washington D.C.

28203

Carolinas Medical Center, Charlotte

30303

Emory University, Department of Medicine, Atlanta

34222

Duke University Medical Center, Durham

37232

Vanderbilt University Medical Center, Nashville

60141

Hines VA Medical Center, Hines

60611

Chicago VA Medical Center (Lakeside), Chicago

72205

Central Arkansas Veterans Health System, Little Rock

77009

Michael Debakey Veterans Affairs Medical Center, Houston

78284

Audi L. Murphy VA Hospital, San Antonio

80204

Denver Department of Public Health and Hospitals, Denver

90033

LA County/USC Medical Center, Los Angeles

92103

UCSD Medical Center, San Diego

94110

University of California, San Francisco, San Francisco

98104

Seattle King County Health Department, Seattle

21287-0003

Johns Hopkins University School of Medicine, Baltimore

02118

Boston Medical Center, Boston

07107-3001

New Jersey Medical School, Newark

76107-2699

University of North Texas Health Science Center, Fort Worth

cep: 21941.590

Universidade Federal do Rio de Janeiro, Rio de Janeiro

Canada V5Z 4R4

University of British Columbia, Vancouver

CANADA R3A 1R8

University of Manitoba, Winnipeg

H2X 2P4Pq Canada

Montreal Chest Institute McGill University, Montreal

08023

Agencia de Salut Publica, Barcelona

All Listed Sponsors
collaborator

US Department of Veterans Affairs

FED

lead

Centers for Disease Control and Prevention

FED

NCT00023452 - Three Months of Weekly Rifapentine and Isoniazid for M. Tuberculosis Infection | Biotech Hunter | Biotech Hunter