Leishmaniasis Development

 

  • Target disease: Visceral Leishmaniasis
  • Main Partners (since project start): Institute of Endemic Disease, Khartoum University, Sudan; Kenya Medical Research Institute, Kenya; Kacheliba District Hospital, Kenya; University of Gondar, Ethiopia; Research Foundation of the Netherlands Cancer Institute, the Netherlands; Makerere University, Uganda; Uppsala University, Sweden; Amudat Hospital, Uganda; Leishmaniasis East Africa Platform.
  • Funding (since project start): Department for International Development (DFID), UK; Médecins Sans Frontières/ Doctors without Borders, International; Swiss Agency for Development and Cooperation (SDC), Switzerland.

 

Overall Objective:

  • Assess the efficacy and safety of two combination regimens of paromomycin and miltefosine as compared to SSG&PM for the treatment of primary VL patients in Eastern Africa.

 

A Phase III clinical trial will be conducted in East Africa to compare the efficacy and safety of two combination regimens of miltefosine and paromomycin with the current standard VL treatment sodium stibogluconate (SSG)-paromomycin, in both paediatric and adult patients. Sites will be located in Kenya, Sudan, Uganda and Ethiopia. If the combination is proven safe and efficacious, current treatment would no longer rely on SSG, an injectable drug, which would be replaced with miltefosine, an oral drug. A safer, more field-adapted, patient-friendly treatment would particularly benefit children, who represent a high proportion of the population at risk in East Africa. The trial protocol is under finalization and will be submitted to ethics committees and regulatory authorities in early 2017.

 

Last update: February 2017