Assessment of the Safety, Tolerability, and Effectiveness of Rifapentine Given Daily for LTBI
Status:
Active, not recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
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.