drugset / Trial / NCT06568484
Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent TB
Phase 2/3
Recruiting
2530 enrolled
Johns Hopkins University
Elizabeth Glaser Pediatric AIDS Foundation · collabUS Department of State · collab
RandomizedParallel-groupSingle-blindPrevention
Summary
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.
Timeline
- Start
- 2026-05-08
- Primary completion
- 2027-07
- Completion
- 2027-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bedaquiline | Small molecule | — | — |
| Subject | Isoniazid | Small molecule | — | — |
| Comparator | Levofloxacin | Small molecule | — | — |
| Subject | Rifapentine | Small molecule | — | — |