84
Participants
Start Date
August 15, 2016
Primary Completion Date
January 7, 2019
Study Completion Date
February 4, 2021
Bedaquiline
Four 100 mg tablets (400 mg) orally once a day for 2 weeks, followed by two 100 mg tablets (200 mg) orally three times a week for 22 weeks.
Delamanid
Two 50 mg tablets (100 mg) orally with food twice a day for 24 weeks.
Dolutegravir
For HIV-positive participants only: one 50 mg tablet orally once daily, to be used in combination with two NRTIs until study completion. (NRTIs were not provided by the study.)
Multidrug Background Treatment (MBT) for TB
A standardized MBT regimen for MDR- or RR-TB except in cases where a participant had known resistance to one of the components of local standard treatment. MBT was provided by the local program.
Task Applied Science (TASK) CRS, Cape Town
South African Tuberculosis Vaccine Initiative (SATVI) CRS, Cape Town
Barranco CRS, Lima
National Institute of Allergy and Infectious Diseases (NIAID)
NIH