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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

2,530

Participants

Timeline

Start Date

December 31, 2025

Primary Completion Date

July 31, 2027

Study Completion Date

September 30, 2027

Conditions
Tuberculosis, Latent
Interventions
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 (tuberculin skin test \[TST\] or interferon-gamma release assay \[IGRA\])~2. Adults, pregnant people, 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 the participant is a CC~3HP: 3 months of weekly isoniazid (H) and rifapentine (P) (12 doses)~1HP: 1 month of daily isoniazid (H) and rifapentine (P) (28 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)"

Trial Locations (6)

Unknown

HNSEB (Hospital Nacional Sergio E. Bernales), Lima

SES Policlinico, Lima

Kilimanjaro Clinical Research Institute, Moshi

Joint Clinical Research Centre, Kampala

Makerere Lung Institute, Kampala

MU-JHU Care Ltd., Kampala

All Listed Sponsors
collaborator

Elizabeth Glaser Pediatric AIDS Foundation

OTHER

collaborator

US Department of State

UNKNOWN

lead

Johns Hopkins University

OTHER