Assessment of the Safety, Tolerability, and Effectiveness of Rifapentine Given Daily for LTBI

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

3,400

Participants

Timeline

Start Date

August 1, 2019

Primary Completion Date

December 31, 2029

Study Completion Date

December 31, 2029

Conditions
Latent Tuberculosis
Interventions
DRUG

Rifapentine daily for 6 weeks

600 mg of Rifapentine (RPT) given once daily (o.d., omni die) for 6 weeks (6wP).

DRUG

Rifapentine and Isoniazid weekly for 12 weeks

"Rifapentine (RPT) 900 mg and isoniazid (INH) 900 mg given once-weekly for 12 weeks (3HP).\*~\*Dose adjustments based on patient's weight will be made according to ATS/CDC/IDSA guidelines.~RPT 900 mg once-weekly for persons weighing \> 50 kg. For persons weighing \< 50 kg, the following doses will be given: weight \> 25-32 kg - RPT 600 mg; weight \> 32-50 kg - RPT 750 mg; + INH 15 mg/kg (round up to nearest 50 or 100 mg; 900 mg max)."

DRUG

Rifampin and Isoniazid daily for 12 weeks

"Rifampin (RIF) 600 mg and Isoniazid (INH) 300 mg given once-daily for 12 weeks (3HR)\*.~\*Dose adjustments based on patient's weight will be made according to ATS/CDC/IDSA guidelines.~RIF 600 mg daily for persons weighing \> 50 kg. For persons weighing \< 50 kg, give 10 mg/kg daily; round up to nearest 50 or 100 mg; + INH 5 mg/kg daily (rounded up to nearest 50 or 100 mg; 300 mg max)."

DRUG

Rifampin daily for 16 weeks

"Rifampin (RIF) 600 mg given once-daily for 16 weeks (4R).\*~\*Dose adjustments based on patient's weight will be made according to ATS/CDC/IDSA guidelines.~RIF 600 mg daily for persons weighing \> 50 kg. For persons weighing \< 50 kg, 10 mg/kg daily; round up to nearest 50 or 100 mg."

Trial Locations (16)

10001

RECRUITING

New York Harbor Healthcare System, Manhattan

11201

RECRUITING

New York City Bureau of TB Control, New York

20001

RECRUITING

George Washington University, Washington D.C.

RECRUITING

Washington DC VA Medical Center, Washington D.C.

78201

RECRUITING

San Antonio VA, San Antonio

80204

RECRUITING

Denver Health and Hospital Authority, Denver

98101

RECRUITING

Seattle King County Health Department, Seattle

Unknown

RECRUITING

Liverpool Hospital, Sydney

RECRUITING

Paramatta Chest, Sydney

RECRUITING

Royal Prince Alfred Hospital, Sydney

RECRUITING

Edmonton TB Clinic, Edmonton

RECRUITING

British Columbia Centre for Disease Control, Vancouver

NOT_YET_RECRUITING

Desmond Tutu TB Center, Stellenbosch

T1Y 6H6

RECRUITING

Calgary TB Clinic, Calgary

M5P 1N5

RECRUITING

Toronto Western Hospital, Toronto

H3A 0G4

RECRUITING

McGill University Health Centre, Montreal

All Listed Sponsors
lead

Centers for Disease Control and Prevention

FED