Overview

TB Alliance and its partners conducted NC-005, a Phase 2B trial of the BPaZ and BPaMZ regimen to further explore their potential to be improved TB treatments. This trial included people with drug-sensitive as well as people with some forms of multidrug-resistant TB. It was conducted at 10 sites across Uganda, South Africa, and Tanzania. The results of NC-005 led to the SimpliciTB trial testing the BPaMZ regimen.

NC-005 is supported by the efficacy and safety of BPaZ that has thus far been proven in a two-week clinical study completed in 2014, as well as pre-clinical models. The two-week study found that the BPaZ regimen killed more than 99% of TB bacteria over the course of 14 days, and that the treatment was safe. The NC-005 study tested this regimen’s efficacy and safety over two months of treatment as well as the BPaMZ regimen.

The trial also investigated a simpler dosing scheme for bedaquiline that could lead to fewer pills and an overall less complicated treatment for patients, as well as answer additional questions that could lead to expanded use of this important drug as part of a novel regimen. 

Protocol
Find the NC-005 clinical trial protocol here. 

Results 
Bedaquiline, moxifloxacin, pretomanid, and pyrazinamide during the first 8 weeks of treatment of patients with drug-susceptible or drug-resistant pulmonary tuberculosis: a multicentre, open-label, partially randomised, phase 2b trial