Results from Study 31/A5349 were presented today at the Union World Conference on Lung Health. This study was conducted internationally through the Tuberculosis Trials Consortium (TBTC) and the AIDS Clinical Trials Group (ACTG) with funding from the CDC and NIH. Vanderbilt University Medical Center/Nashville Metro Public Health is a participating TBTC site, though did not enroll patients into this trial. April Pettit, VUMC faculty member, was a member of the protocol team.
From the CDC Press Release:
"Results from an international, randomized, controlled clinical trial indicate that a four-month daily treatment regimen containing high-dose, or “optimized,” rifapentine with moxifloxacin is as safe and effective as the existing standard six-month daily regimen at curing drug-susceptible tuberculosis (TB) disease. This regimen is the first successful short-course treatment regimen for drug-susceptible TB disease in almost 40 years. TB is one of the most important global health problems. According to recent estimates from the World Health Organization, 10 million new TB cases and 1.4 million deaths from TB occurred globally in 2019. While the United States has achieved substantial progress in reducing TB, with fewer than 10,000 cases each year, too many people still suffer from TB disease.
The Phase 3, open-label trial, called Study 31/A5349, was led by the U.S. Centers for Disease Control and Prevention’s (CDC) Tuberculosis Trials Consortium (TBTC) with collaboration from the AIDS Clinical Trials Group (ACTG) funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. It is the largest drug-susceptible TB disease treatment trial that CDC or NIAID has ever conducted, with more than 2,500 participants ages 12 and older enrolled at 34 clinical sites in 13 countries. The trial included 214 people with HIV. Results were presented today at the virtual Union World Conference on Lung Health and have been submitted for publication."
Full Press Release: https://www.cdc.gov/nchhstp/newsroom/2020/landmark-tb-trial-media-statement.html?s_cid=tw-cdctb_202010210001