Actively Recruiting
Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent TB
Led by Johns Hopkins University · Updated on 2026-05-12
2530
Participants Needed
6
Research Sites
68 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
E
Elizabeth Glaser Pediatric AIDS Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent TB
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Any age with bacteriologically proven pulmonary tuberculosis who started treatment within the past 90 days and have at least one close contact likely eligible for the study
- People living with HIV on a dolutegravir-based or approved integrase inhibitor ART regimen that does not interact with study drugs
- Close contacts of drug-sensitive or rifampin-resistant TB patients who meet specific risk groups including children 0 to <5 years old regardless of HIV or latent TB status, and individuals ≥5 years old with latent TB infection or HIV infection
- Ability and willingness to provide informed consent (and assent if applicable)
- Documentation of HIV status and antiretroviral therapy as specified
- Chest X-ray without active tuberculosis within 30 days prior to enrollment
- Laboratory values within acceptable limits for liver, kidney function, and blood counts within 30 days prior to enrollment
- Negative pregnancy test within 7 days prior to enrollment for those of childbearing potential
You will not qualify if you...
- Unwilling or unable to provide informed consent
- Weighing 3 kg or less
- Current diagnosis of confirmed, probable, or possible tuberculosis disease at enrollment
- Previously completed tuberculosis disease treatment or preventive therapy
- Enrolled in another therapeutic clinical trial
- Severe renal or hepatic impairment, acute hepatitis, severe cardiac arrhythmia, or peripheral neuropathy grade 2 or higher
- Porphyria diagnosis
- Corrected QT interval over 460 msec
- Unable to take oral medication
- Active drug or alcohol dependence interfering with treatment adherence
- Serious illness requiring systemic treatment or hospitalization within 30 days prior to enrollment
- Prior exposure to bedaquiline or clofazimine
- Recent use of isoniazid, rifamycin, or fluoroquinolone (more than 7 days in past 90 days)
- Known bedaquiline resistance in index patient
- Allergy or hypersensitivity to study drugs
- Use of prohibited medications that cannot be stopped or require long washout
- Known pregnancy or breastfeeding
- For close contacts of rifampin-resistant TB patients: known fluoroquinolone resistance in index patient or severe tendinopathy related to fluoroquinolones
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
HNSEB (Hospital Nacional Sergio E. Bernales)
Lima, Peru
Not Yet Recruiting
2
SES Policlinico
Lima, Peru
Not Yet Recruiting
3
Kilimanjaro Clinical Research Institute
Moshi, Tanzania
Actively Recruiting
4
Joint Clinical Research Centre
Kampala, Uganda
Not Yet Recruiting
5
Makerere Lung Institute
Kampala, Uganda
Not Yet Recruiting
6
MU-JHU Care Ltd.
Kampala, Uganda
Not Yet Recruiting
Research Team
B
Bonnie S. King, MHS
CONTACT
K
Kate Boehner, RN, MSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here