Regimen

Delamanid, Bedaquiline, OPC-167832

Compounds in Regimen
Description

Delamanid + Bedaquiline + OPC-167832 10 mg

Delamanid + Bedaquiline + OPC-167832 30 mg

Delamanid + Bedaquiline + OPC-167832 90 mg

Control: RHEZ (6 months)

Arm 1: DLM (300 mg once daily [QD]) + BDQ (400 mg QD x 2 weeks, then 200 mg thrice-weekly [TIW]) + OPC-167832 (10 mg QD) for 17 weeks

Arm 2: DLM (300 mg QD) + BDQ (400 mg QD x 2 weeks, then 200 mg TIW) + OPC-167832 (30 mg QD) for 17 weeks

Arm 3: DLM (300 mg once daily [QD]) + BDQ (400 mg QD x 2 weeks, then 200 mg TIW) + OPC-167832 (90 mg QD) for 17 weeks

Arm 4: RHEZ for 8 weeks followed by 18 weeks of rifampin and isoniazid (for a total of 26 weeks)

Randomization will be stratified by HIV status (yes or no) and presence of bilateral cavitation on screening chest x-ray (yes or no). After the end of the treatment period, subjects will be followed until 12 months postrandomization.