Leishmaniasis Development

 

  • Target disease: VL
  • Main partners (since project start): BRAZIL: Rene Rachou Research Center– Fiocruz-MG, Belo Horizonte; Paediatric Hospital Joao Paulo II – FHEMIG, Belo Horizonte; Brasilia University; Montes Claros State University; Piaui Federal University, Teresina; Sergipe Federal University, Aracaju; Leishmaniasis Control Programme/Ministry of Health; Universidade Estadual do Rio de Janeiro; Hospital Sao José de Doencas Infecciosas, Fortaleza.
  • Project start: February 2011
  • Funding (since project start): Associação Bem-Te-Vi Diversidade, Brazil; CNPq/FINEP; Department for International Development (DFID), UK; Médecins Sans Frontières/Doctors without Borders, International; Medicor Foundation, Liechtenstein; Ministry of Health, Brazil; Spanish Agency for International Development Cooperation (AECID), Spain; Swiss Agency for Development and Cooperation (SDC), Switzerland; Other private foundations and individuals.

 

Overall Objective:

  • Assess the efficacy and safety of amphotericin B deoxycholate, AmBisome® and AmBisome® combined with Glucantime®, as compared to the first-line treatment, Glucantime®, for the treatment of VL patients in Brazil, supporting the Brazilian Ministry of Health and its partners.

 

In 2011, a Phase IV study sponsored by the Brazilian Ministry of Health was initiated at five sites in Brazil to evaluate the efficacy and safety of Amphotericin B deoxycholate, AmBisome® and a combination of AmBisome® and Glucantime®, in comparison to Glucantime®, the existing first-line treatment of VL. 378 patients were recruited. Brazil’s national guidelines for VL were revised in 2013 based on the interim safety data from the trial. While Glucantime® remains the first-line treatment, AmBisome® replaced Amphotericin B deoxycholate as a second-line treatment. The final results of this trial were presented to the Ministry of Health, and are expected to guide further policy change in Brazil.


Last update: February 2017