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.
A diagnosis of bacteriologically proven pulmonary TB
Initiated on treatment for pulmonary TB within the past 90 days
Have at least one close contact that is likely to be eligible for the study
On a dolutegravir-based or other approved integrase inhibitor antiretroviral therapy (ART) regimen that does not interact with bedaquiline or rifapentine.
Severe renal impairment (DAIDS Grade 4) or end-stage renal disease requiring hemodialysis or peritoneal dialysis
Severe hepatic impairment (Child-Pugh C)
Evidence of acute hepatitis, such as abdominal pain, jaundice, dark urine, and/or light stools within 90 days prior to enrollment
Severe cardiac arrythmia requiring medication
Johns Hopkins University
Lead sponsor
Elizabeth Glaser Pediatric AIDS Foundation
Collaborator
US Department of State
Collaborator