LeishmaniasisDevelopment

 

  • Target disease: Visceral leishmaniasis (VL)
  • Main Partners (since project start): Academic Medical Center in Amsterdam, The Netherlands; Amudat Hospital, Uganda; Institute of Endemic Disease, Khartoum University, Sudan; Kacheliba District Hospital, Kenya; Kenya Medical Research Institute, Kenya; KAVI-Bio-Zeq, Kenya; LEAP; Makerere University, Uganda; Ministries of Health, Ethiopia, Kenya, and Sudan; Research Foundation of The Netherlands Cancer Institute, The Netherlands; University of Gondar, Ethiopia; Uppsala University, Sweden. 
  • Funding (since project start): Department for International Development (DFID), UK; Dutch Ministry of Foreign Affairs (DGIS), The Netherlands; European and Developing Countries Clinical Trials Partnership (EDCTP); Federal Ministry of Education and Research (BMBF through KfW), Germany; Médecins Sans Frontières/ Doctors without Borders, International; Swiss Agency for Development and Cooperation (SDC), Switzerland.

 

Overall objective:

  • Compare the efficacy and safety of two combination regimens of miltefosine and paromomycin with the current standard treatment

 

 

Based on the good results of the miltefosine and paromomycin (MF+PM) combination in South Asia, and on the need for an alternative and safer treatment to replace SSG, a Phase III study was launched in 2018 to compare two combination regimens of MF+PM with the current standard visceral leishmaniasis treatment, SSG&PM.

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.

 

The first patient in Sudan was enrolled in January 2018.

In 2018, 126 patients were recruited in five sites in Sudan (Doka), Kenya (Kacheliba), Ethiopia (Gondar and Abdurafi) and Uganda (Amudat). Two additional sites in Sudan were scheduled for initiation in early 2019.

In 2017, the study protocol went through a joint review facilitated by WHO-AVAREF (African Vaccine Regulatory Forum), with representatives from AVAREF, the National Ethic Committees, and regulatory authorities from Ethiopia, Kenya, Sudan, and Uganda. A clinical site was initiated in Dooka, Sudan in December 2017 and the first patient recruited in January 2018. Clinical sites in Kenya (Kacheliba) and Ethiopia (Gondar) are about to be initiated, followed by additional 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: August 2019