TBTC Study 31/ACTG A5349 demonstrated that a 4-month regimen using
high-dose rifapentine and moxifloxacin was non-inferior to the 6-month standard of
care regimen, with no increased risk of adverse events. The high-dose rifapentine arm
without moxifloxacin was not non-inferior. The identification of a safe and effective 4-
month regimen for the treatment of drug-susceptible tuberculosis is a monumental
achievement and represents the first major advance in treating the most common form
of tuberculosis in almost 40 years. The study team is enormously grateful to all Clinical
Research Sites for hard work of this trial and the powerful partnership of TBTC and ACTG
We have also provided a draft letter for you to share with study participants. Participant
Letter should be sent to the local IRB/IEC for review and approval before distribution to
study participants.
The team thanks you for your work on this pivotal trial. If you have questions, please
communicate with the team via email (