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

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.

INCLUSION CRITERIA For Index Patient • Any age * 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 For PLHIV Indication Individuals must meet all of the following inclusion criteria to participate in this study: * On a dolutegravir-based or other approved integrase inhibitor antiretroviral therapy (ART) regimen that does not interact with bedaquiline or rifapentine. * If on a protease inhibitor-based ART regimen, a participant can be enrolled following a 5-day washout with switch to a dolutegravir-based regimen prior to enrollment. A 14-day washout is required for efavirenz-based ART regimen with switch to a dolutegravir-based regimen prior to enrollment * If a participant is not currently on ART or is ART-naïve, the participant must have started a dolutegravir-based ART regimen prior to Enrollment. * PLHIV who meet criteria for a TBD close contact should be enrolled under the close contact indication For Close Contact Indication (DS- or RR-TB Index Patient) * Definition of Close Contact (either/or): o Lives or lived in the same dwelling unit or plot of land and shares or has shared the same housekeeping arrangements as the Index Patient for one or more nights ≤ 90 days prior to the Index Patient starting TB treatment o Has shared more than four hours of indoor airspace with the Index Patient during any one-week period ≤ 90 days prior to the Index Patient starting TB treatment. This may include indoor airspace within or outside the home. * Close contacts must be in one of the following high-risk groups: * All children 0 to \=18 months of age known to be PLHIV: * Certified copy of HIV clinic card or * Certified copy of HIV testing that includes date, assay used and result For participants \