NC001

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BACKGROUND:

New drugs, but also shorter, better-tolerated regimens are needed to tackle the high global burden of tuberculosis complicated by drug resistance and retroviral disease. We investigated new multiple-agent combinations over the first 14 days of treatment to assess their suitability for future development.

NC002

Submitted by james on

The New Combination 2 (NC-002) trial continued to develop the PaMZ TB treatment regimen. The PaMZ regimen is comprised of new TB drug candidates PA-824 and moxifloxacin, along with the existing TB drug, pyrazinamide. The Phase 2, 8-week trial was the first of its kind, as it will enroll both drug-sensitive TB (DS-TB) and multidrug-resistant (MDR-TB) patients and treat them with the same regimen. If successful, NC-002 will pave the way for Phase 3 registration studies of the PaMZ regimen. NC-002 was launched in 2012 and completed in 2013. 

Pediatric PK and Safety Trial Delamanid in MDR TB

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From CT.gov:

This trial investigates the pharmacokinetics (PK) and safety of delamanid administered twice daily for 10 days to pediatric patients aged birth to 17 years who are also on therapy with an optimized background regimen. The purpose of the trial is to determine which dose in pediatric MDR-TB patients will result in delamanid plasma exposure similar to efficacious plasma exposure in adult MDR-TB patients. This is an age de-escalation trial in four groups:

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