• Target disease: Visceral Leishmaniasis
  • Main Partners (since project start): Amsterdam Medical Center, The Netherlands; Institute of Endemic Disease, Khartoum University, Sudan; Kenya Medical Research Institute, Kenya; Kacheliba District Hospital, Kenya; Ministries of Health, Ethiopia, Kenya, Sudan, Africa; University of Gondar, Ethiopia; Research Foundation of The Netherlands Cancer Institute, The Netherlands; Makerere University, Uganda; Uppsala University, Sweden; Amudat Hospital, Uganda; LEAP.
  • 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 a combination regimen 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 a combination regimen of miltefosine and PM with the current standard VL treatment sodium stibogluconate (SSG)&PM, 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, but 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.


Clinical sites for the Phase III study started with the recruitment of the first patient in Sudan (Dooka) in January 2018. Clinical sites in Kenya (Kacheliba) and Ethiopia (Gondar) are about to be initiated, followed by other sites in Uganda and Kenya.

The trial protocol is under finalization and will be submitted to ethics committees and regulatory authorities in early 2017.


Last update: March 2018