Project: Towards an arsenic-free oral treatment for human African trypanosomiasis due to Tb rhodesiense as a tool for disease elimination

Acronym	HAT-r-ACC (Reference Number: RIA2017NCT-1846)
Duration	01/09/2018 - 31/08/2023
Project Topic	DNDi’s long-term goal for sleeping sickness is to develop and register two new drugs that are effective against both stage one and stage two of the disease, also known as human African trypanosomiasis (HAT), and both subspecies of the parasite, Trypanosoma brucei gambiense and Trypanosoma brucei rhodesiense. Better treatments for rhodesiense sleeping sickness are urgently needed: the only treatment available for stage two rhodesiense sleeping sickness is melarsoprol, a toxic arsenic drug dating from the 1940s that kills up to 5% of patients it is meant to cure. Whilst the treatment option for stage one, suramin, is less toxic, it is difficult to administer, requiring five intravenous injections given every seven days for the duration of a month. Without prompt diagnosis and treatment, sleeping sickness is usually fatal. Rhodesiense sleeping sickness progresses more rapidly than gambiense sleeping sickness, causing death within months. Fexinidazole, the first all-oral drug, 10-days, once-a-day treatment for sleeping sickness developed in clinical trials led by DNDi and added to the World Health Organization’s List of Essential Medicines in July 2019, is currently only indicated as a treatment for Tb gambiense HAT, the most common form of the disease. The target of this project is to extend the indication to Tb rhodesiense HAT. To provide clinical data to assess the safety and efficacy of treating both stages of rhodesiense sleeping sickness with fexinidazole, we have joined with partners to form the HAT-r-ACC consortium. The consortium started working in September 2018 on a five-year project in Uganda and Malawi. The project has two main actions, being the central one the execution of a clinical trial adapted to the low prevalence of the disease. This study will have a complementary action towards community intervention and extension of the capacity to detect cases within the health system of the most endemic areas in both countries. The aim is to support WHO control and elimination efforts in East Africa by providing evidence for the potential use of a new, less toxic and easier to administer oral treatment for both stages of T.b. rhodesiense HAT. The consortium also aims to support national sleeping sickness control programmes in Malawi and Uganda to raise awareness of rhodesiense sleeping sickness among affected communities and increase early detection of cases. The first patient was included in the trial at the end of September 2019. HAT-r-ACC webpage : https://www.dndi.org/diseases-projects/portfolio/fexinidazole-tb-rhodesiense/
Network	EDCTP2
Call	Targeting control and elimination of NIDs through clinical trials

Project partner

Number	Name	Role	Country
1	Drugs for Neglected Diseases initiative	Coordinator	Switzerland
2	Association Epicentre	Partner	France
3	Institut de Recherche pour le Développement	Partner	France
4	Makerere University	Partner	Uganda
6	Malawi Ministry of Health and Population	Partner	Malawi
8	Swiss Tropical and Public Health Institute	Partner	Switzerland
9	Uganda National Health Research Organisation	Partner	Uganda
10	Universidade Nova de Lisboa	Partner	Portugal