NCT06568484

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 2,530 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

Treating adult, adolescent, child, and pregnant close contacts (CCs) of drug-sensitive tuberculosis (DS-TB) who are high-risk for developing tuberculosis disease (TBD) as well as adult and adolescent people living with HIV (PLHIV) in high-tuberculosis burden regions with bedaquiline (BDQ) will be noninferior in reducing the risk of developing TBD compared with a WHO-recommended rifamycin-containing short-course regimen for TB preventive therapy (TPT). Treating adult, adolescent, child, and pregnant CCs of rifampin-resistant tuberculosis (RR-TB) who are high-risk for developing TBD with BDQ will be noninferior in reducing the risk of developing TBD compared with levofloxacin.

Conditions

• Tuberculosis, Latent

Interventions

Type	Name	Description
DRUG	Bedaquiline	CCs (Close Contacts) of DS-TB Index Patients and PLHIV at high risk of developing TBD 1. Children 0 to \<5 years old who are HIV negative, regardless of latent tuberculosis infection (LTBI) result by TST (tuberculin skin test) or IGRA (interferon-gamma release assay) 2. Adults, pregnant people, adolescents, and children ≥5 years old who are HIV negative and LTBI positive (by IGRA) 3. Adults and adolescents ≥15 years of age who are living with HIV regardless of LTBI status, regardless of whether the participant is a CC CCs of RR-TB Index Patients at high risk of developing TBD 1. Children 0 to \<5 years old, regardless of HIV status or LTBI result (by TST or IGRA) 2. Adults, adolescents, and children ≥5 years old who are HIV negative and LTBI positive (by IGRA) 3. Adults, pregnant people, adolescents, and children ≥5 years old who are living with HIV regardless of LTBI status Bedaquiline based on weight and/or age at Enrollment daily for four weeks (28 doses)
COMBINATION_PRODUCT	Isoniazid, rifapentine	CCs of DS-TB Index Patients and PLHIV at high risk of developing TBD 1. Children 0 to \<5 years old who are HIV status negative, regardless of latent tuberculosis infection (LTBI) result (WHO-recommended skin test or interferon-gamma release assay \[IGRA\]) 2. Adults, adolescents, and children ≥5 years old who are HIV status negative and LTBI positive (by IGRA) 3. Adults and adolescents ≥15 years of age who are living with HIV regardless of LTBI status, regardless of whether they are a CC 3HP: 3 months of weekly isoniazid (H) and rifapentine (P) (12 doses)
DRUG	Levofloxacin	CCs of RR-TB Index Patients at high risk of developing TBD 1. Children 0 to \<5 years old, regardless of HIV status or LTBI result (by TST or IGRA) 2. Adults, adolescents, and children ≥5 years old who are HIV status negative and LTBI positive (by IGRA) 3. Adults, pregnant people, adolescents, and children ≥5 years old who are living with HIV regardless of LTBI status Levofloxacin (LFX) based on weight at Enrollment daily for 6 months (182 doses)

Timeline

• Start date: 2026-07-01
• Primary completion: 2027-07-01
• Completion: 2027-09-01
• First posted: 2024-08-23
• Last updated: 2026-03-27

Locations

6 sites across 3 countries: Peru, Tanzania, Uganda