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Clofazimine- and Rifapentine-Containing Treatment Shortening Regimens in Drug-Susceptible Tuberculosis: The CLO-FAST Study

HIV Clinical Trial

Official title:
A Phase IIc Trial of Clofazimine- and Rifapentine-Containing Treatment Shortening Regimens in Drug-Susceptible Tuberculosis: The CLO-FAST Study

Clinical Trial Summary

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).

Clinical Trial Description

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 (TB). 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04311502
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Active, not recruiting
Phase Phase 2
Start date June 16, 2021
Completion date June 23, 2024
View Details
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