DNDi’s first clinical trial site in Um El Kher, Sudan, is up and running. The first patient started treatment on 17 November 2004. Over the next 6 months, 150 patients are expected to join the trial LEAP 0104 at this site managed by Médecins Sans Frontières (MSF) and led by Dr Manica Balasegaram.
Other trial sites are Kassab Hospital, Gadaref State Sudan; Gondar and Arba Minch hospitals in Ethiopia; and Kenya Medical Research Institute (KEMRI) in Kenya.
LEAP 0104 is a phase III multi-centre, randomised, controlled, comparative trial which will provide efficacy and safety data on paromomycin, the comparator sodium stibogluconate-SSG (current standard treatment), and a combination of both products used together in a short course. More than 700 patients will participate altogether.
The objective of the LEAP 0104 trial is to provide data to register paromomycin (PM) as a new alternative treatment for visceral leishmaniasis in East Africa (Sudan, Ethiopia, and Kenya).
Paromomycin, a drug for visceral leishmaniasis, is currently also undergoing Phase III clinical trials in India under the aegis of the Institute of One World Health, but needs to be registered in African countries too if patients there are to gain access to it. DNDi, in collaboration with IOWH, will use the data generated from Africa and India to develop a global strategy for paromomycin.
This project is a collaborative effort, with strategic direction from members of the Leishmania East Africa Platform (LEAP), a group of experts from the leishmaniasis-endemic countries of Africa and DNDi. Project management will be provided by DNDi, the AfricaDNDi liaison office based at KEMRI, Nairobi, and the partner institutions: Faculty of Medicine, Addis Ababa University Ethiopia; Institute for Endemic Diseases, University of Khartoum Sudan; KEMRI; and MSF.
For more information contact Jaya Banerji: +41 79 210 9378; jbanerji@dndi.org
You can learn more about DNDi’s work at www.dndi.org
