Gates Package — page 587

NIAID - BILL & MELINDA GATES FOUNDATION PARTNERSHIPS GLOBAL HEALTH HIGHLIGHTS OF CURRENT ACTIVITIES • Tuberculosis o The TB Biomarker Development Consortium is a collaboration between the NIAID AIDS Clinical Trials Group (ACTG), CDC TB Trials Consortium (CDC/TBTC) and the Global Alliance for Tuberculosis Drug Development (GATB) to facilitate the discovery and qualification of biomarkers for TB treatment outcome using a common sample collection and processing protocol to biobank biologic samples linked to clinical and microbiological data from TB patients during treatment and follow-up. As of mid-2013, biological samples have been collected from 1/3 of the 1000 targeted TB treated patients. Biosamples are anticipated to be available to qualified researchers by 2014/2015. o ACTG is collaborating with the GATB to conduct three clinical studies: ▪ A5306: a Phase I study to evaluate the safety and pharmacokinetic interaction of PA824, an investigational Nitroimidazole for the treatment of tuberculosis, together with efavirenz, ritonavir-boosted lopinavir, or rifampin. This study is closed to follow up. ▪ A5304/REMox: a randomized placebo-controlled double blind trial comparing two treatment shortening regimens with the standard regimen (two months ethambutol, isoniazid, rifampicin and pyrazinamide) followed by four months isoniazid and rifampicin. This study is closed to follow up. ▪ A5289: a randomized controlled Phase II study in intensive phase treatment of drugsensitive TB in HIV infected and uninfected individuals with pulmonary TB. This study is in development. o DMID is collaborating with GATB to conduct a phase 1 study to assess the effects ofsupratherapeutic doses of clofazimine on the QTc interval in healthy subjects. DMID has also collaborated with GATB to conduct a phase 1 study to assess the effects of PA-824 and PA-824 plus moxifloxacin on QTc interval in healthy subjects and to conduct a phase 1 study to assess the interaction of rifabutin or rifampin and bedaquiline in healthy subjects o NIAID is involved in the Critical Paths to TB Drug Regimens (CPTR) initiative (http://cptrinitiative.org/), which is funded by the BMGF. This partnership brings together the world's leading pharmaceutical and other drug developers, global regulatory agencies, and civil society organizations to support advances in regulatory science, the development of infrastructure, and other progress needed to facilitate the development and availability of new TB drug treatments. NIAID staff serve as co-chairs on CPTR working groups to assure coordination with NIAID activities and are represented on the CPTR Advisory Panel (Dr. Fauci or delegate). o The Regional Prospective Observational Research for Tuberculosis (RePORT) project,established under the Indo-U.S. Vaccine Action Program (VAP) Initiative on Tuberculosis Research,was awarded in 2013. The aim of this initiative involving joint teams of Indian and U.S. scientists is to build and enhance biomedical and clinical research capacity in India by establishing long-term