Leishmaniasis Development

 

  • Target disease: PKDL
  • Main partners (since project start): International Centre for Diarrhoeal Disease Research, Bangladesh; Rajendra Memorial Research Institute of Medical Sciences, India; Kala Azar Medical Research Centre, India; Institute of Medical Sciences, Banaras Hindu University, India; Uppsala University, Sweden; Institute of Endemic Disease, Khartoum University, Sudan; Ministry of Health, Sudan; LEAP.
  • Project start: March 2015
  • Funding (since project start): Department for International Development (DFID), UK; Médecins Sans Frontières/Doctors without Borders; WHO-TDR (Demonstration Project).

 

Overall Objective:

  • To determine the safety and efficacy of two treatment regimens for patients with PKDL, mainly in the Indian Sub-continent and East Africa.

 

DNDi is prioritizing the management of PKDL patients who are believed to constitute a reservoir of infection for visceral leishmaniasis in the Indian Sub-continent and East Africa.

A Phase II study testing both AmBisome® monotherapy and a combination of AmBisome® and miltefosine is underway in India and Bangladesh to assess the safety and efficacy for patients with post-kala-azar dermal leishmaniasis (PKDL). A separate Phase II study to assess the safety and efficacy of both AmBisome® in combination with miltefosine, and paromomycin in combination with miltefosine, is planned in Sudan. Site visits have been undertaken at all participating sites in the three countries, and protocols and study documents are under finalization for submission to ethical and regulatory review. In addition, two PKDL infectivity studies are under preparation in Bangladesh and Sudan. Their objective is to establish the infectivity of PKDL patients to sandflies, to determine if PKDL patients maintain inter-epidemic transmission of VL.  If this is confirmed, early treatment of PKDL patients would be critical elements of any VL public health and elimination strategy.


Last update: February 2017