drugset / Trial / NCT04311502
Clofazimine- and Rifapentine-Containing Treatment Shortening Regimens in Drug-Susceptible Tuberculosis: The CLO-FAST Study
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study was to compare a 3-month rifapentine (RPT)/clofazimine (CFZ)-containing regimen with a CFZ loading dose with the 6-month standard of care (SOC) regimen for drug-susceptible (DS) tuberculosis (TB).
Timeline
- Start
- 2021-11-05
- Primary completion
- 2024-06-24
- Completion
- 2025-06-24
Outcome
Missed primary endpoint
Stopped (Enrollment): “Accrual was permanently closed due to futility in the experimental arm on June 22, 2023. Follow-up in the experimental arm was extended to 117 weeks.”
registry analysis (superiority test); Arm 1: Experimental vs Arm 2: Standard of Care; p = 0.21; Hazard Ratio (HR) 1.21 (90% CI 0.82 to 1.79); Regression, Cox NCT04311502 ↗
Publications
- Mugodhi F, Kanyama C, Makiya F, Metcalfe J, Potani C, Scarsi KK, Weir I, Furin J. "Six months is a lot of time to lie": Anticipated stigma, disclosure and treatment preferences among participants in a tuberculosis therapeutic trial. Res Sq [Preprint]. 2025 Dec 22:rs.3.rs-8277920. doi: 10.21203/rs.3.rs-8277920/v1.
- Metcalfe JZ, Weir IR, Scarsi KK, Mendoza-Ticona A, Pierre S, Hall L, Leon-Cruz J, Svensson EM, Koele SE, Samaneka W, Kanyama C, Yohane M, Nevrekar N, Ntsalaze B, Marc JB, Goth M, Maartens G, Chaisson R; ACTG A5362 study team. A 3-month clofazimine-rifapentine-containing regimen for drug-susceptible tuberculosis versus standard of care (Clo-Fast): a randomised, open-label, phase 2c clinical trial. Lancet Infect Dis. 2026 Jan;26(1):46-54. doi: 10.1016/S1473-3099(25)00436-0. Epub 2025 Sep 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clofazimine | Small molecule | 100 mg | — |
| Subject | Ethambutol | Small molecule | 800 mg | — |
| Subject | Ethambutol | Small molecule | 1200 mg | — |
| Subject | Ethambutol | Small molecule | 1600 mg | — |
| Subject | Isoniazid | Small molecule | 300 mg | — |
| Subject | Pyrazinamide | Small molecule | 1000 mg | — |
| Subject | Pyrazinamide | Small molecule | 1500 mg | — |
| Subject | Pyrazinamide | Small molecule | 2000 mg | — |
| Comparator | Rifampicin | Small molecule | 600 mg | — |
| Subject | Rifapentine | Small molecule | 1200 mg | — |