Status: Recruiting
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.
Participants needed: 2,530
Trial details
Phase: Phase 2, Phase 3Biological sex: AllType: InterventionalSponsor: Johns Hopkins UniversityUpdated: Aug 18, 2026Locations: 8
Eligibility criteria
A diagnosis of bacteriologically proven pulmonary TB [+23]
Severe renal impairment (DAIDS Grade 4) or end-stage renal disease requiring hem... [+17]