references
STRENGTHENING EXISTING CAPACITIES
Colombia
Venezuela
Mexico Guatemala Honduras Ecuador Paraguay Uruguay Brazil
CHAGAS CLINICAL RESEARCH PLATFORM (CCRP)
Founded: 2009 in Uberaba, Brazil Over 90 institutions represented from 23 countries, bringing together over 300 people
Bolivia
Chile
2015 HIGHLIGHTS
• Number of CCRP members grew by 23%; about 40% of new members come from non-endemic countries. • The Annual Chagas Clinical Research Platform Meeting in Buenos Aires, Argentina (Aug.) in the context of the National Chagas Week, with 230 attendees (from 17 countries) from, among others, national programmes, patient associations, research and clinical care centres, NGOs, and pharmaceutical companies.
Treatments & Access
In 2015, the Platform continued its engagement on access issues, namely with Global Chagas Coalition and Regional Initiatives meetings convened by PAHO and the national programmes, for instance at the Andean Countries Initiative meeting (Peru, Sept.) or at the Central America & Mexico Initiative meeting (Costa Rica, Nov.) CCRP also contributed to the Chagas Access Implementation Project on access to diagnosis and treatment, through pilot projects in Colombia (as of April); Mexico, USA, Brazil, and Gran Chaco will follow in 2016-17. The CCRP continued to strongly support the registration process for benznidazole in Mexico.
Argentina
Countries highlighted on the map represent Chagas disease-endemic Latin American countries with platform members. Other CCRP members’ countrie are listed below.
The CCRP brings together partners, experts, and stakeholders to provide support for the evaluation and development of new treatments for Chagas disease. This patient-centred platform aims to facilitate clinical research, provide a forum for technical discussions, develop a critical mass of expertise, and strengthen institutional research capacities. In addition, it identifies and reviews priority needs, works towards standardization of methodology to assess drug efficacy, and reviews alternatives for using current approved drugs (new schemes, doses, combination).
Argentina was concluded: no clinically relevant PK, safety, or tolerability issues identified. In addition, the CCRP worked towards integration of clinical trial results from different research groups and institutions, as well as harmonization of clinical trial designs in Chagas disease.
“Enabling discussions among researchers is an important tool for the improvement of efficiency, diagnosis, and treatment.“
Concepción Zúniga Valeriano, Medical doctor, Head of CHAGASHonduras
Clinical Trials • The Phase II New Benznidazole Regimens study: protocol finalization and study design definition, consensus on the study read-outs, and quality systems. • The Phase II Fexinidazole study in Bolivia to evaluate the treatment of adult patients with chronic Chagas disease: in 2015, the enrolled patients were monitored for 12 months post-treatment. • The Phase I Drug-drug interaction study of fosravuconazole with benznidazole in
Capacity Strengthening In 2015, 12 experts’ and technical meetings were held in Mexico, Argentina, Bolivia, and Spain, namely a Target Product Profile workshop in Barcelona with 25 participants (March); the Experts’ Meeting (NHEPACHA Network) in Barcelona & Buenos Aires; and the Latin-American Chagas Summit, organized by the National Programme in Mexico, with 235 attendees (July). The DNDi Chagas Team also taught two courses to CCRP members: Introduction to Clinical Trials (Córdoba, Argentina) and Introductory Course on Research (Tarija, Bolivia). Communications The fourth edition of the CCRP newsletter was published in July. The Web Forum has been actively used by CCRP members as an online workspace for discussion, sharing of information, and debate.
