The purpose of this study is to compare a 3-month rifapentine (RPT)/clofazimine
(CFZ)-containing regimen with CFZ loading dose versus 6-month standard of care (SOC) for
drug-susceptible (DS) tuberculosis (TB).
This study will compare a 3-month rifapentine (RPT)/clofazimine (CFZ)-containing regimen with
CFZ loading dose versus 6-month standard of care (SOC) for drug-susceptible (DS) tuberculosis
Randomization will be stratified based on HIV status and the presence of advanced disease as
determined by chest X-ray.
Participants will be randomized to one of three arms:
Arm 1 (Experimental): rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + CFZ 300 mg
once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then
rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks
Arm 2 (SOC): rifampicin/isoniazid/pyrazinamide/ethambutol (RHZE) for 8 weeks; then
rifampicin/isoniazid (RH) for 18 weeks
Arm C (Pharmacokinetic [PK]-only subgroup): PHZE + CFZ 100 mg once daily for 4 weeks;
then remain on study, off study medications and treated according to SOC (RHZE for 4
weeks; then RH for 18 weeks)
All participants must receive pyridoxine (vitamin B6) with each dose of isoniazid (INH) based
on current local, national or international dosing guidelines.
Arm 1 participants will be treated for 13 weeks (including a 2-week CFZ loading dose of 300
mg daily). Arm 2 participants will be treated for 26 weeks, and Arm C participants will be
treated for 4 weeks.
All participants in Arms 1, 2, and C will be followed from randomization to Week 65. Study
visits may include physical examinations; blood, urine, and/or sputum collection; chest
X-rays; and electrocardiograms (ECG).
human immunodeficiency virus,
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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