390
Participants
Start Date
April 14, 2023
Primary Completion Date
October 31, 2027
Study Completion Date
December 30, 2027
BTZ-043
BTZ-043 1000mg once daily in arms 4 and 6.
Rifampicin
Rifampicin will be dosed in a fixed high-dose (2100 mg for arms 1 and 2) or a weight-banded regular dose (10 mg/kg) in arm 3, 5 and 7.
Isoniazid
Isoniazid will be dosed at fixed dose of 300mg in arms 1 and 2, and regular dose of 5 mg/kg in arm 3 and 7.
Pyrazinamide
Pyrazinamide will be dosed in a fixed regular dose in arm 1 (1600 mg), a weight banded high dose in arm 2 (2000/2400 mg) or a weight-banded regular dose (25 mg/kg) in arm 3, 5 and 7.
Moxifloxacin
Moxifloxacin will be dosed at 600 mg orally once daily in arms 1-2.
Alpibectir (GSK3729098)
Alpibectir 45 mg OD plus Ethionamide 500 mg OD combined with rifampicin pyrazinamide and ethambutol at standard weight-banded doses in arm 5.
Ganfeborole (GSK3036656)
Ganfeborole 20 mg OD in arm 6
Delpazolid (LCB01-0371)
Delpazolid 1200mg OD in arm 6
Pretomanid (Pa)
Pretomanid 20mg OD in arm 6.
Ethambutol (E)
Ethambutol 20mg/Kg OD in arm 3, 5 and 7
Ethionamide
Ethionamide 500mg OD in arm 5.
NOT_YET_RECRUITING
Isango Lethemba TB Research Unit. Clinical HIV Research Unit (CHRU), Wits Health Consortium., Port Elizabeth
RECRUITING
TASK Applied Sciences Clinical Research Centre, Cape Town
NOT_YET_RECRUITING
University of Cape Town Lung Institute, Cape Town
COMPLETED
Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné
RECRUITING
Kamuzu College of Health Sciences (formerly College of Medicine), Blantyre
RECRUITING
Instituto Nacional de Saúde (INS), Maputo
RECRUITING
National Institute for Medical Research (NIMR-MMRC), Mbeya
RECRUITING
Ifakara Health Institute (IHI), Bagamoyo
RECRUITING
Kilimanjaro Clinical Research Institute (KCRI), Moshi
RECRUITING
Makerere University Lung Institute Limited, Kampala
Collaborators (2)
Radboud University Medical Center
OTHER
University of California, San Francisco
OTHER
University College, London
OTHER
GlaxoSmithKline
INDUSTRY
LigaChem Biosciences, Inc.
INDUSTRY
Michael Hoelscher
OTHER