- 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.
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 visceral leishmaniasis 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 a Phase III study to compare two combination regimens of miltefosine and paromomycin with the current standard visceral leishmaniasis treatment, sodium stibogluconate and paromomycin, in both paediatric and adult patients started with the recruitment of the first patient in Sudan (Dooka) in January 2019. 126 patients were recruited in five sites in Sudan (Doka), Kenya (Kacheliba), Ethiopia (Gondar and Abdurafi) and Uganda (Amudat). An additional site in Sudan (Um El Kher) will be initiated 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.
Last update: February 2019