Assessment of the Safety, Tolerability, and Effectiveness of Rifapentine Given Daily for LTBI (ASTERoiD)

  • STATUS
    Recruiting
  • End date
    Dec 27, 2023
  • participants needed
    3400
  • sponsor
    Centers for Disease Control and Prevention
Updated on 27 July 2022
immunosuppressive
chest x-ray
interferon
isoniazid
x-rays
rifampin
co-infections
tnf-alpha
skin test
nucleic acid amplification test
interferon-gamma release assay
rifapentine
pulmonary tuberculosis
rifamycin

Summary

This study is conducted to compare the safety and effectiveness of a novel short 6-week regimen of daily rifapentine (6wP, experimental arm) with a comparator arm of 12-16 weeks of rifamycin-based treatment (standard of care, control arm) of latent M. tuberculosis infection (LTBI).

This trial is conducted among persons who are at increased risk of progression to tuberculosis (TB) and require treatment of LTBI. The study will be conducted in the United States, the United Kingdom, and other countries with low to moderate TB incidence (< 100 TB cases per 100,000 population) that have treatment of LTBI as their standard of care and offer 12-16 week rifamycin-based therapy as standard of care.

The hypothesis of this study is that the safety and effectiveness of the experimental treatment (6wP arm) is non-inferior to a comparator arm of 12-16 weeks of rifamycin-based treatment of LTBI (control arm).

Participants are enrolled and randomly assigned to one of the two study arms: experimental 6wP or control. The comparator (control) arm's treatment regimens include 12 weeks of once-weekly isoniazid (INH) and rifapentine (3HP), 12 weeks of daily INH and rifampin (3HR), and 16 weeks of daily rifampin (4R). A total of 560 participants per arm (1,120 total) for the evaluation of safety and 1,700 participants per arm (3,400 total) for the evaluation of effectiveness will be enrolled, given treatment as per randomization assignment, and followed for 24 months from the date of enrollment.

After completion of data collection, statistical analyses will be conducted to compare proportions of drug discontinuation due to adverse drug reaction (ADR) and proportions of newly diagnosed tuberculosis between 6wP and control arm.

Details
Condition Latent Tuberculosis
Treatment Rifapentine daily for 6 weeks, Rifapentine and Isoniazid weekly for 12 weeks, Rifampin and Isoniazid daily for 12 weeks, Rifampin daily for 16 weeks
Clinical Study IdentifierNCT03474029
SponsorCenters for Disease Control and Prevention
Last Modified on27 July 2022

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