2,530
Participants
Start Date
December 31, 2025
Primary Completion Date
July 31, 2027
Study Completion Date
September 30, 2027
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)"
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)"
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)"
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
Elizabeth Glaser Pediatric AIDS Foundation
OTHER
US Department of State
UNKNOWN
Johns Hopkins University
OTHER