Comparing a 6-Week Daily Rifapentine Regimen to 12-16 Week Rifamycin-Based Treatments for Latent Tuberculosis Infection to Assess Safety and Effectiveness

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a new short 6-week daily rifapentine treatment compared to the standard 12-16 week rifamycin-based treatments for latent Mycobacterium tuberculosis infection LTBI. This trial focuses on people at higher risk of developing active tuberculosis TB and is conducted in locations with varying TB rates where LTBI treatment is routinely provided. The study aims to determine if the shorter treatment is not less safe or effective than the longer standard treatments. Participants are randomly assigned to one of two treatment groups the experimental group receives 600 mg of rifapentine daily for 6 weeks, while the control group receives one of three standard regimens lasting 12 to 16 weeks, including combinations of rifapentine, isoniazid, and rifampin. Dose adjustments are made based on patient weight following established guidelines. Treatments are given according to random assignment and participants are followed for 24 months to assess outcomes. During the study, researchers monitor treatment completion rates, adverse drug reactions, and new cases of active tuberculosis. Safety assessments include tracking serious side effects and drug discontinuation rates. Effectiveness is measured by the occurrence of culture-confirmed or clinical TB within 24 months of enrollment. The study involves regular evaluations and follow-up visits over two years to collect data on treatment tolerability, safety, and TB prevention outcomes.

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