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

NCT04311502 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2025-08-27

Study results available
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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).

Conditions

Interventions

DRUG

Rifapentine

1200 mg once daily

DRUG

Rifampicin

600 mg once daily

DRUG

Isoniazid

300 mg once daily

DRUG

Pyrazinamide

1000mg once daily if weight is 40 to \<55kg; 1500mg once daily if weight is 55 to \<71kg; 2000mg once if weight is ≥71kg

DRUG

Ethambutol

800 mg once daily if weight is 40 to \<55kg; 1200 mg once daily if weight is 55 to \<71kg; 1600mg once if weight is ≥71kg

DRUG

Clofazimine loading dose

300 mg once daily for 2 weeks (loading dose), then 100 mg once daily

DRUG

Clofazimine 100 MG

100 mg once daily

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • John Metcalfe, MD, PhD, MPH · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-05
Primary Completion
2024-06-24
Completion
2025-06-24
FDA Drug
Yes

Countries

  • Haiti
  • India
  • Malawi
  • South Africa
  • Zimbabwe

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04311502 on ClinicalTrials.gov