LeishmaniasisDevelopment

 

  • Target disease: PKDL
  • Main partners (since project start): International Centre for Diarrhoeal Disease Research, Bangladesh; i+solutions, The Netherlands; Instituto de Salud Carlos III, Spain; Kala Azar Medical Research Centre, India; Institute of Medical Sciences, Banaras Hindu University, India; Uppsala University, Sweden; Institute of Endemic Disease, Khartoum University, Sudan; LEAP; Muzaffarpur Hospital, India; Ministry of Health, Sudan; National Institute of Pathology, India; Netherlands Cancer Institute; The Netherlands; Rajendra Memorial Research Institute of Medical Sciences, India; SK Hospital, Mymensingh, Bangladesh; University of Gedaraf, Sudan.
  • Project start: March 2015
  • Funding (since project start): Department for International Development (DFID), UK; French Development Agency (AFD), France; 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 potential reservoir of infection for VL in the Indian Sub-continent and East Africa. Early treatment of PKDL patients could be critical elements of any VL public health and elimination strategy.

 

Recruitment started with 6 patients enrolled in clinical sites in India (RMRI in Patna and KAMRC in Muzzafarpur) for the Phase II study to test both AmBisome® monotherapy and a combination of AmBisome® and miltefosine, while the clinical site in Bangladesh received final approvals and is preparing for initiation. The clinical site in Sudan (Dooka) for the Phase II study to test both AmBisome® in combination with miltefosine, and paromomycin in combination with miltefosine is in preparation for the initiation visit. The PKDL infectivity study in Bangladesh completed the recruitment of 65 patients. In Sudan, the preparation of the insectarium for the same study continues.

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 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 sand flies, to determine if PKDL patients maintain interepidemic transmission of VL.


Last update: March 2018