Contribution of the AfriCoLeish project to the FP7 Health call objectives
The objective of the AfriCoLeish project is to develop and deliver a package of care for VL patients in East Africa through safe and cost-effective treatments, therefore improving current case management and contributing to disease control in the region, the main objectives are:
Objective 1 - Fexinidazole Phase II PoC study and miltefosine allometric dose pharmacokinetics and safety study in paediatric VL patients:
Objective 2 - Secondary prophylaxis for VL in HIV co-infected patients:
- To provide evidence for the development of future oral treatments in East Africa based on optimised treatment regimens.
- Description: Fexinidazole open, single arm Phase II PoC clinical trial; miltefosine allometric dose pharmacokinetics and safety study in paediatric VL patients (Phase II non-comparative open-label clinical trial, children 4-12y).
Objective 3 - Treatment of VL in HIV co-infected patients:
- To deliver a preventive intervention for VL in HIV co-infected patients that limits the recurrence of VL through use of secondary prophylaxis (pentamidine 4mg/kg IV once monthly) and that is safe and feasible to implement in the East African context.
- Description: This is a descriptive study to assess the safety, feasibility and effectiveness of pentamidine secondary prophylaxis.
Objective 4 - Capacity Building:
- To identify and deliver a safe and highly effective treatment for VL in HIV co-infected patients as part of a package of management that will improve long-term survival in these patients.
- Description: This work package will evaluate the 40mg/kg dose of AmBisome and a combination of Ambisome 30mg/kg and miltefosine in VL-HIV co-infected patients in a Phase II multi-centre randomised, non-comparative trial
Objective 5 - Dissemination of results to support translation into policy and implementation of treatments:
- To ensure relevant staff of the AfriCoLeish project have the knowledge and skills to conduct all aspects of clinical trials, including data management, statistical analysis planning and reporting and ensure that good practice guidelines and ethical criteria are applied coherently across all Consortium activities.
- Description: This will involve the training of health care workers depending on a needs basis in areas specific to clinical trial conduct (research ethics / GCP / laboratories / GCLP). In addition, young researchers will be offered an opportunity to obtain a PhD through the academic institutions involved in the Consortium. Lastly, WP4 will also offer training capacity building for DNDi LEAP Data Centre in the area of statistical design, data collection, analysis and reporting.
- To ensure dissemination of results to support translation into policy and implementation of treatments. This will be facilitated by the development of project logo and website, press release dissemination and coordination of AfriCoLeish partner participation at key stakeholder forums.
- Description: This WP will be led by Dr Wasunna (DNDi Africa) who will co-ordinate and provide additional support through LEAP and the coordination centre in Nairobi (arranging regional LEAP meetings/training, etc.) for regional dissemination. Depending on the location, the local Consortium participants will take on a lead role, as well as that of host. IED and Gondar (together with Addis Ababa University) will take the lead in their individual countries and also play a key role in regional dissemination as members of LEAP