Expand New Drug Markets for TB (endTB)

Investigator: Patrick Phillips, PhD, MS, MA
Sponsor: Partners In Health

Location(s): Ethiopia; Kenya; Lesotho; Kazakhstan; Kyrgyzstan; North Korea; Afghanistan; Bangladesh; Pakistan; Indonesia; Viet Nam; Myanmar; Armenia; Georgia; Belarus; Peru; Haiti


For the first time in over 40 years, two new anti-TB drugs (bedaquiline and delamanid) have been developed. While the WHO has produced interim policy recommendations on their clinical use, very few patients have received these new drugs as part of national TB treatment programs. The endTB Project will provide these two new drugs in a closely monitored multi-country cohort of 2,600 patients in 15 countries. The endTB Project will also implement a clinical trial among 600 additional patients to identify novel treatment regimens that are shorter and less toxic than current MDR-TB treatment regimens. Through these activities, the end TB project will:

1) Generate evidence of safety and efficacy of new TB drugs.

2) Accelerate uptake of new TB drugs and novel MDR-TB regimens.

3) Facilitate change in evidence-based WHO recommendations.

All endTB patients will benefit from a strong pharmacovigilance system and will be actively monitored for potential adverse events through a regular schedule of clinical evaluations and laboratory monitoring tests that is consistent with WHO recommendations.