93
Participants
Start Date
July 26, 2023
Primary Completion Date
February 6, 2025
Study Completion Date
February 6, 2025
Delamanid, Bedaquiline, OPC-167832, and Sutezolid (DBOS)
D- 300 milligram (mg) once daily (QD) for treatment duration; B- 400 mg QD for 2 weeks, 200 mg thrice weekly for remaining treatment weeks; O- 30 mg QD for treatment duration and S- 1200 mg QD for treatment duration
Pretomanid, Bedaquiline, OPC-167832, and Sutezolid (PBOS)
P- 200 mg QD for treatment duration; B- 400 mg QD for 2 weeks, 200 mg thrice weekly for remaining treatment weeks; O- 30 mg QD for treatment duration and S- 1200 mg QD for treatment duration
Isoniazid, Rifampicin, Pyrazinamide, Ethambutol (HRZE)
Fixed dose combination (FDC) of 75 mg of isoniazid, 150 mg of rifampicin, 400 mg of pyrazinamide, and 275 mg of ethambutol (HRZE) (Standard of Care \[SOC\]). All the doses administered will be weight-based.
Pretomanid or Delamanid, Bedaquiline, OPC-167832, and Sutezolid (XBOS)
X - Pretomanid 200 mg QD for treatment duration OR Delamanid 300 mg QD for treatment duration; B - 400 mg QD for 2 weeks, 200 mg thrice weekly for remaining treatment weeks; O- 30 mg QD for treatment duration and S-1200 mg QD for treatment duration
Isoniazid and Rifampicin (HR)
Fixed dose combination (FDC) of 75 mg of isoniazid and 150 mg of rifampicin (HR) (Standard of Care \[SOC\]). All the doses administered will be weight-based.
Tropical Disease Foundation, Makati
Lung Center of the Philippines, Quezon City
Silang Specialist Medical Center, Silang
Bio-Medical Research Institute; Faculty of Medicine and Health Sciences, Stellenbosch University; Tygerberg Medical Campus, Cape Town
TASK - Central (Brooklyn), Cape Town
UCT (Cape Town); General Medicine & Global Health (GMGH); Hatter Heart Research Institute, Cape Town
UCT South African Tuberculosis Vaccine Initiative (SATVI), Cape Town
University of Cape Town (UCT) Lung Institute, Cape Town
CHRU - Durban, Durban
Synergy Biomed Research Institute, East London
Clinical HIV Research Unit (CHRU) - Johannesburg, Johannesburg
The Aurum Institute (Tembisa CRS), Johannesburg
Perinatal HIV Research Unit (PHRU), Klerksdorp
Lead Sponsor
Collaborators (2)
Global Alliance for TB Drug Development
OTHER
Janssen Pharmaceuticals
INDUSTRY
Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
Gates Medical Research Institute
OTHER