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

NCT06568484 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 2530

Last updated 2026-05-12

No results posted yet for this study

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.

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 (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)

Sponsors & Collaborators

  • Elizabeth Glaser Pediatric AIDS Foundation

    collaborator OTHER

  • US Department of State

    collaborator UNKNOWN

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Eric Nuermberger, MD · Johns Hopkins School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-08
Primary Completion
2027-07-31
Completion
2027-09-30

Countries

  • Peru
  • Tanzania
  • Uganda

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06568484 on ClinicalTrials.gov