Investigational Three-Month Tuberculosis Regimen Is Safe but Ineffective, NIH Study Finds

Investigational Three-Month Tuberculosis Regimen Is Safe but Ineffective, NIH Study Finds

Publication date: Jul 13, 2023

The first clinical trial of a three-month tuberculosis (TB) treatment regimen is closing enrollment because of a high rate of unfavorable outcomes with the investigational course of treatment. An interim data analysis showed that participants taking the investigational regimen experienced ongoing or recurring TB at rates above thresholds set in the study protocol. The interim results of the CLO-FAST trial do not support advancing this specific regimen for further evaluation, but the study data will provide essential evidence to inform TB science. NIAID continues to prioritize research to advance TB treatment, including evaluating new drug combinations to simplify or shorten treatment duration. NIAID and the A5362 study team express deep gratitude to the study sites and participants who took part in the CLO-FAST trial. Read more at NIH Follow up of participants in the investigational arm will be extended from 65 weeks to 117 weeks. AIDS Clinical Trials Group 5362, also known as the CLO-FAST trial, sought to evaluate the safety and efficacy of a three-month clofazimine- and high-dose rifapentine-containing regimen.

Concepts Keywords
Decade Clo
Pharmacokinetics Clofazimine
Tuberculosis Dose
Zimbabwe Dsmb


Type Source Name
drug DRUGBANK Isoniazid
drug DRUGBANK Pyrazinamide
drug DRUGBANK Ethambutol
drug DRUGBANK Rifampicin
disease MESH infection
disease MESH Infectious Diseases
disease MESH Allergy
drug DRUGBANK Rifapentine
drug DRUGBANK Clofazimine
disease MESH Tuberculosis
pathway KEGG Tuberculosis
disease MESH AIDS

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