LEAP 0104: A Multi-Country Clinical Trial

In 2010, the Leishmaniasis East Africa Platform (LEAP) completed a multi-centre, multi-country clinical trial (LEAP 0104) sponsored by DNDi in Kenya, Ethiopia, Sudan, and Uganda. The LEAP 0104 study involved over 1100 VL patients and showed that a short-course combination of PM (15mg/kg/day) and SSG (20mg/kg/day) had a similar safety and efficacy profile (efficacy at 6 months follow up post-treatment > 90%) as the standard SSG monotherapy treatment (SSG 20mg/kg/day for 30 days). The trial also demonstrated that the use of PM (15 or 20 mg/kg/day) alone for 21 days resulted in significantly lower efficacy. Thus the use of the combination will be critical to prolonging the use of both drugs in the region, particularly PM.

Implementation

From 22 to 26 March 2010, the World Health Organization convened an expert committee meeting that recommended the use of the combination of SSG&PM as a first-line regimen for the treatment of visceral leishmaniasis (VL) in the East African region.

Following this, the Ministry of Health in Sudan recommended the use of this therapy to treat VL.

Registration of paromomycin for use in combination with SSG for VL in the region was obtained in Uganda and Kenya, and it is ongoing for Sudan and Ethiopia.
Nonetheless, implementation at the field level has already commenced in Sudan and South Sudan with over 10’000 doses distributed.