Comparing 4 Weeks of Bedaquiline to Standard TB Preventive Treatments in People Living with HIV and High-Risk Close Contacts

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a new tuberculosis TB prevention treatment using bedaquiline compared to standard WHO-recommended treatments among people living with HIV PLHIV and high-risk close contacts of adults with drug-sensitive or rifampin-resistant TB. This Phase IIIII open-label trial aims to find out if four weeks of bedaquiline is not worse than existing treatments in preventing confirmed or probable TB over 72 weeks of follow-up. Participants will be assigned to one of three treatment groups 4 weeks of daily bedaquiline, 3 months of weekly isoniazid and rifapentine, or 6 months of daily levofloxacin. The trial includes adults, adolescents, children, and pregnant individuals who are close contacts of TB patients or are PLHIV. Each treatment is given according to weight and age, with specific dosing schedules over 1 to 6 months, and participants will be monitored closely for safety and treatment completion. During the study, participants will undergo assessments including chest X-rays, laboratory tests for liver and kidney function, pregnancy tests when applicable, and monitoring for adverse events. Researchers will track treatment completion, safety by adverse drug reactions, and whether participants develop TB disease during the 72-week follow-up after starting treatment. The study involves careful follow-up visits to collect data on health status, medication adherence, and any side effects experienced by participants.

Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent TB