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

If these new combinations are proven safe and effective, treatment would no longer rely on sodium stibogluconate, 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.

Project updates

2020

Enrolment in DNDi’s Phase III study was completed in May 2020, after a total of 439 patients, including both children and adults, were enrolled across seven sites in Ethiopia, Kenya, Sudan, and Uganda. The last patient follow-up visit was completed in December 2020. Monitoring visits and data analysis will continue through 2021, with study completion planned for late 2021.

2019

By January 2020, a total of 350 patients, both children and adults, were enrolled in the study across seven sites in Ethiopia (Gondar and Abdurafi), Kenya (Kacheliba), Sudan (Dooka, Um el Kher, and Tabarak Allah), and Uganda (Amudat). Completion of patient enrollment is targeted for August 2020.

2018

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.

2017

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.

2016

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