Clinical Research Directory

Inclusion Criteria: * Signed informed consent * DS-TB as defined as sensitive to rifampicin and isoniazid by rapid sputum-based test AND either newly diagnosed for TB or have a history of being untreated for at least 3 years after cure from a previous episode of TB * Of non-childbearing potential OR using effective birth control methods * Body weight ≥ 35 kg Exclusion Criteria: * Karnofsky score \< 60 at screening * Any evidence of extrapulmonary TB * Cardiovascular or QT prolongation risk factors * Pregnant or breast-feeding Any of the following lab toxicities: * Platelets \<100,000/mm³ * Creatinine \>1.3 x ULN * Haemoglobin \<9.5 g/dL or \<95 g/L * Absolute neutrophil count \<800/mm³ * Serum potassium less than the lower limit of normal for the laboratory. * ALT and/or AST ≥2.5 x ULN * Total bilirubin ≥1.6 x ULN * Direct bilirubin \>1 x ULN * Haemoglobin A1c ≥8.0% * Total lipase ≥1.5 x ULN * Total amylase ≥1.5 x ULN * CPK \>3 x ULN (if \>3 x ULN, enquire about the participant's recent strenuous activity and consider repeating the test within the screening window) * TSH \>1 x ULN * Positive results at screening for HBsAg, HAV IgM, or hepatitis C antibodies For participants living with HIV only: * CD4+ count\<200 cells/μL. * WHO Clinical Stage 4 HIV disease * Participant does not agree to use DTG/TFV/3TC during trial if ARV therapy is indicated, and randomised to the TBAJ876 or the B-Pa-L regimen * If initiation of ARV therapy is indicate, participants who are known to be intolerant, non-responsive to DTG/TFV/3TC or have DTG/TFV/3TC as a contraindication.