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RECRUITING
NCT03474029
PHASE2/PHASE3

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

Sponsor: Centers for Disease Control and Prevention

View on ClinicalTrials.gov

Summary

This study is conducted to compare the safety and effectiveness of a novel short 6-week regimen of daily rifapentine (6wP, experimental arm) with a comparator arm of 12-16 weeks of rifamycin-based treatment (standard of care, control arm) of latent M. tuberculosis infection (LTBI). This trial is conducted among persons who are at increased risk of progression to tuberculosis (TB) and require treatment of LTBI. The study will be conducted in low, medium and high TB incidence settings that have treatment of LTBI as their standard of care and offer 12-16 week rifamycin-based therapy as standard of care. The hypothesis of this study is that the safety and effectiveness of the experimental treatment (6wP arm) is non-inferior to a comparator arm of 12-16 weeks of rifamycin-based treatment of LTBI (control arm). Participants are enrolled and randomly assigned to one of the two study arms: experimental 6wP or control. The comparator (control) arm's treatment regimens include 12 weeks of once-weekly isoniazid (INH) and rifapentine (3HP), 12 weeks of daily INH and rifampin (3HR), and 16 weeks of daily rifampin (4R). A total of 560 participants per arm (1,120 total) for the evaluation of safety and 1,700 participants per arm (3,400 total) for the evaluation of effectiveness will be enrolled, given treatment as per randomization assignment, and followed for 24 months from the date of enrollment. After completion of data collection, statistical analyses will be conducted to compare proportions of drug discontinuation due to adverse drug reaction (ADR) and proportions of newly diagnosed tuberculosis between 6wP and control arm.

Official title: Six Weeks of Daily Rifapentine vs. a Comparator Arm of 12-16 Week Rifamycin-based Treatment of Latent M. Tuberculosis Infection: Assessment of Safety, Tolerability and Effectiveness

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

3400

Start Date

2019-08-01

Completion Date

2029-12

Last Updated

2024-09-26

Healthy Volunteers

No

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.

Locations (16)

Denver Health and Hospital Authority

Denver, Colorado, United States

George Washington University

Washington D.C., District of Columbia, United States

Washington DC VA Medical Center

Washington D.C., District of Columbia, United States

New York Harbor Healthcare System

Manhattan, New York, United States

New York City Bureau of TB Control

New York, New York, United States

San Antonio VA

San Antonio, Texas, United States

Seattle King County Health Department

Seattle, Washington, United States

Liverpool Hospital

Sydney, Australia

Paramatta Chest

Sydney, Australia

Royal Prince Alfred Hospital

Sydney, Australia

Calgary TB Clinic

Calgary, Alberta, Canada

Edmonton TB Clinic

Edmonton, Alberta, Canada

British Columbia Centre for Disease Control

Vancouver, British Columbia, Canada

Toronto Western Hospital

Toronto, Ontario, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Desmond Tutu TB Center

Stellenbosch, South Africa