references
STRENGTHENING EXISTING CAPACITIES
HUMAN AFRICAN TRYPANOSOMIASIS (HAT) PLATFORM
Founded: 2005 in Kinshasa, Democratic Republic of the Congo Over 120 individual members, representing over 20 institutions
2015 HIGHLIGHTS
• Recruitment of patients to the fexinidazole Phase II/III study completed (394 patients) • Participation in the 33rd International scientific council of research and control of trypanosomiasis in Ndjamena, Chad, with 53 attendees (Sept.)
Treatments & Access
Dem. Rep. of the Congo
Capacity strengthening
Training on Trypanosomiasis management was co-organized between Chad’s national sleeping sickness control programme and the HAT Platform in Dinamadji district (Chad) with the support of DRC national control programme; 22 doctors and nurses attended (August). The platform also supported HAT clinical training in South Sudan, with 36 attendees (Nov). An investigators’ meeting on fexinidazole trials was organized in Kinshasa, DRC, with 18 attendees (July).
Chad Sudan South Sudan
Rep. of Guinea Rep. of the Congo Angola
Central African Republic Uganda
In 2015, NECT improved therapy has been used as first-line treatment for stage 2 sleeping sickness in almost all T. b. gambiense detected patients. The platform attended the meeting of the Consultative Scientific Committee to the national control programme of DRC in Kinshasa, DRC (Sept.), where the DRC national HAT policy was reviewed and recommendations were issued. This could help other national programmes to revise and update their policies, particularly considering WHO’s new target for elimination of the disease by 2020.
Clinical trials • Fexinidazole Phase II/III study: Inclusion
The HAT platform builds and strengthens treatment methodologies and clinical trial capacity in sleeping sicknessendemic countries, so that new treatments for this fatal disease can be rapidly and effectively evaluated, registered, and made available to patients. After the success of Nifurtimox-Eflornithine Combination Therapy (NECT), included in the WHO List of Essential Medicines for the treatment of stage 2 HAT, the primary goals of the HAT Platform have been to develop appropriate clinical trial methodologies for sleeping sickness, overcome system challenges related to administrative and regulatory requirements, strengthen clinical trial capacity (human resources, infrastructure, equipment), and share information and strengthen ties between endemic countries.
of all 394 patients completed in April. Two additional cohort studies have enrolled the following: 230 stage 1 and early stage 2 adult patients and 125 children aged 6-14 years (all stages). A total of 749 patients have been included. • SCYX-7158 Phase II/III study: This single dose oral treatment will be tested in 210 stage 2 and around 150 stage 1 patients in DRC. Recruitment is planned to start in 2016. Three new clinical sites, N’gandajika, Bolobo, and Kwamouth (DRC), were selected and prepared in 2015.
Communications
The 16th edition of the HAT Platform newsletter was published in 2015.
“The training in Good Clinical Practice and the site initiation of the clinical study help me on a daily basis to improve the way we take care of all patients.“
Tawaba Say Watson, Nurse head, Bagata, Kwilu province, RDC
