Project Title: An Open-Label, Partially Randomized Trial to Evaluate the Efficacy, Safety and Tolerability of a 4-month Treatment of Bedaquiline plus Pretomanid plus Moxifloxacin plus

Project Description: A phase 2C multi-center, open –label, partially randomized clinical trial in DS-TB and DR-TB participants to evaluate the efficacy, safety and tolerability at 8 weeks( 2 months), 52 weeks (12 months) and 104 weeks (24 months) post the start of the following treatment regimens in participants with drug sensitive TB. Participants with DS-TB will be randomized to one of two treatment arms. These participants will receive either B-PA-M-Z (Bedaquiline, Pretomanid and Pyrazinamide) daily for 17... A phase 2C multi-center, open –label, partially randomized clinical trial in DS-TB and DR-TB participants to evaluate the efficacy, safety and tolerability at 8 weeks( 2 months), 52 weeks (12 months) and 104 weeks (24 months) post the start of the following treatment regimens in participants with drug sensitive TB. Participants with DS-TB will be randomized to one of two treatment arms. These participants will receive either B-PA-M-Z (Bedaquiline, Pretomanid and Pyrazinamide) daily for 17 weeks (4 months), or HRZE/HR combination tablets daily for 26 weeks (6 months) participants will be stratified for co-infection with human immunodeficiency virus (HIV) and cavitation Bedaquilline 200 mg daily for 8 weeks then 100 mg daily for 9 weeks, together with pretomanid 200 mg + moxifloxacion 400 mg + Pyrazinamide 1500 mg daily for 17 weeks (Total treatment duration 4 months) The trial duration is approximately 4 years (18 months enrolment period for DS TB participants, up to 26 week-treatment, and 104 week follow up from start of therapy. Read more

Principal Investigator : Fredrick Haraka

Department Name : BRCT

Time frame: (2018-05-01) - (2024-11-30)

Funding Partners
Global Alliance for TB Drug Development (TB-Alliance) (Normal)
External Collaborating Partners
PPD Investigator Service