Overview

Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients

Status:
Active, not recruiting

Trial end date:
2022-02-25

Target enrollment:

Participant gender:

Summary

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 (DS-TB) patients given BPaMZ for 17 Weeks ( or 4 months) vs. Standard HRZE/HR treatment given for 26 weeks (or 6 months) and Drug Resistant TB (DR-TB) patients given BPaMZ for 26 Weeks (or 6 months)

Phase:

Phase 2/Phase 3

Details

Lead Sponsor:

Global Alliance for TB Drug Development

Treatments:

Bedaquiline
Diarylquinolines
Ethambutol
Fluoroquinolones
Isoniazid
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Pyrazinamide
Rifampin