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

A seamless, staged Phase II/III, open-label, multicenter, non-inferiority trial, to compare the efficacy and safety of 4 weeks of bedaquiline (BDQ) versus a a standard regimen for preventing regimen for preventing confirmed or probable tuberculosis disease (TBD) during 72 weeks of follow-up among people living with HIV (PLHIV) and high-risk Close Contacts (CC) of adults with Drug Susceptible (DS) or Rifampin Resistant (RR) TB.

NCT Number	NCT06568484
Lead Sponsor	Johns Hopkins University Collaborators: Elizabeth Glaser Pediatric AIDS Foundation, US Department of State
Conditions	Tuberculosis, Latent
Enrollment	2,530 participants
Start Date	2026-05-08
Primary Completion	2027-07 (estimated)
Study Completion	2027-09 (estimated)
Updated on ClinicalTrials.gov	2026-06-03