Open Label Phase 3 study - Enrollment ended November 15, 2017. Interim results presented at UNION conference in Guadalajara 2017 and at CROI 2017. Transition to ZeNix with first patient screened 11/16/2017.
Experimental: Bedaquiline + PA-824 + Linezolid
- Incidence of bacteriologic failure or relapse or clinical failure through follow up until 24 months after the end of treatment. [ Time Frame: Treatment Period: Day 1, Week 1, 2, 4, 6, 8, 12, 16, 20, 26, 30, 34, 39 Follow Up: Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 ]
Bacteriologic failure: During the treatment period, failure to attain culture conversion to negative.
Bacteriologic relapse: During the follow-up period, failure to maintain culture conversion to negative status in culture, with culture conversion to positive status with a Mycobacterium tuberculosis (M.tb.) strain that is genetically identical to the infecting strain at baseline.
Clinical failure: A change from protocol-specified TB treatment due to treatment failure, retreatment for TB during follow up, or TB-related death.
Note: Culture conversion requires at least 2 consecutive culture negative/positive samples at least 21 days apart.
Subjects who are documented at a visit as unable to produce sputum and who are clinically considered to be responding well to treatment will be considered to be culture negative at that visit.