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EDCTP portfolio: Clinical Research & Development Fellowships

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The WANETAM network is strengthening clinical research capacity across English-, French- and Portuguese-speaking countries in West Africa.

WANETAM: West African Network for Tuberculosis, AIDS and Malaria

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West Africa was badly affected by the 2014–16 Ebola outbreak, and has a high burden of poverty-related infectious diseases. Although HIV is not as prevalent as in other sub-regions, progress in prevention and rollout of antiretroviral therapy has been relatively slow.

Collaboration across research centres in West Africa is challenged by language barriers. However, several strong research institutions exist in West African countries and have established productive relationships with European partners.

The challenge

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WANETAM was established in 2009 with EDCTP funding, initially with 14 institutions in seven countries; additional African and European partners joined later. WANETAM’s core focus was on capacity building, organising long-term and short-term training, as well as strengthening of laboratory capacities; stronger institutes in the network developed clinical trial units and secured international accreditation. 

Initial funding also provided an opportunity to establish surveillance activities to provide baseline data for future studies. These included work on physiological measures in human subjects as well as antimalarial drug monitoring.  

In follow-up WANETAM II funding, the network is expanding to cover neglected infectious diseases as well as Ebola. Thematic nodes of excellence have been established for each area, complemented by a cross-cutting structured training and collaboration programme. Training covers key areas including project-based training to build research leadership, hands-on clinical studies, platform development to support collaboration, and research support functions. Training will be provided for the full range of staff, including skills development and mentoring for senior staff, master’s-level online courses, and professional development courses and internships.

Training will focus on three priority scientific areas: surveillance, diagnostics and resources to support clinical trial activities.

In the area of TB, work will focus on diagnosis and management of childhood TB, as well as monitoring of TB drug resistance. Malaria studies will include community-based interventions to interrupt transmission, monitoring of insecticide resistance and evaluation of new insecticides, evaluation of new treatments and vaccines, and introduction of a controlled human malaria challenge model.

HIV/AIDS research will cover the development of a unified database across study populations, rollout of viral load assays, and enhancing drug resistance testing. Work on neglected infectious diseases will focus on molecular diagnostics and monitoring of soil-transmitted helminths as well as clinical, laboratory and public health preparedness for rapid outbreak responses.

The project

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WANETAM is strengthening clinical research capacities across multiple West African countries, enhancing coordination of activities and helping to overcome language barriers. It will facilitate large-scale multicentre trials on the key infectious disease threats in the sub-region, and enhance coordinated and rapid responses to outbreaks of emerging diseases such as Ebola.

Impact

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test the safety and efficacy of this new formulation in young children

Bringing antiretroviral drugs to children

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The CHAPAS trials have ensured that many more children with HIV have benefited
from life-saving antiretrovirals.

EDCTP portfolio: HIV & HIV-associated infections

The challenge

West Africa was badly affected by the 2014–16 Ebola outbreak, and has a high burden of poverty-related infectious diseases. Although HIV is not as prevalent as in other sub-regions, progress in prevention and rollout of antiretroviral therapy has been relatively slow.

Collaboration across research centres in West Africa is challenged by language barriers. However, several strong research institutions exist in West African countries and have established productive relationships with European partners.

watermark

WANETAM was established in 2009 with EDCTP funding, initially with 14 institutions in seven countries; additional African and European partners joined later. WANETAM’s core focus was on capacity building, organising long-term and short-term training, as well as strengthening of laboratory capacities; stronger institutes in the network developed clinical trial units and secured international accreditation. 

Initial funding also provided an opportunity to establish surveillance activities to provide baseline data for future studies. These included work on physiological measures in human subjects as well as antimalarial drug monitoring.  

In follow-up WANETAM II funding, the network is expanding to cover neglected infectious diseases as well as Ebola. Thematic nodes of excellence have been established for each area, complemented by a cross-cutting structured training and collaboration programme. Training covers key areas including project-based training to build research leadership, hands-on clinical studies, platform development to support collaboration, and research support functions. Training will be provided for the full range of staff, including skills development and mentoring for senior staff, master’s-level online courses, and professional development courses and internships.

Training will focus on three priority scientific areas: surveillance, diagnostics and resources to support clinical trial activities.

In the area of TB, work will focus on diagnosis and management of childhood TB, as well as monitoring of TB drug resistance. Malaria studies will include community-based interventions to interrupt transmission, monitoring of insecticide resistance and evaluation of new insecticides, evaluation of new treatments and vaccines, and introduction of a controlled human malaria challenge model.

HIV/AIDS research will cover the development of a unified database across study populations, rollout of viral load assays, and enhancing drug resistance testing. Work on neglected infectious diseases will focus on molecular diagnostics and monitoring of soil-transmitted helminths as well as clinical, laboratory and public health preparedness for rapid outbreak responses.

The project

The later CHAPAS-3 trial compared the efficacy and safety of three fixed-dose combinations including two without stavudine (found to have some long-term side effects in adults, leading to a recommendation that its use be discontinued in children). The trial the first of its kind in Africa studied nearly 500 children at four sites in two African countries.

WANETAM is strengthening clinical research capacities across multiple West African countries, enhancing coordination of activities and helping to overcome language barriers. It will facilitate large-scale multicentre trials on the key infectious disease threats in the sub-region, and enhance coordinated and rapid responses to outbreaks of emerging diseases such as Ebola.

ratios forfixed-dose combinations and on appropriatedosage according to weight. 

The CHAPAS-3 trial confirmed the effectiveness of fixed-dose combinations, providing further impetus to the rollout of antiretrovirals to children. Its evidence on abacavir informed the WHO recommendation of abacavir-containing combinations for first-line therapy in children. Trial data have also been used to support applications for regulatory approval for new scored efavirenz tablets.

Impact

L’homme RF et al. Nevirapine, stavudine and lamivudine pharmacokinetics in African children on paediatric fixed-dose combination tablets. AIDS. 2008;22(5):557–65.

Mulenga V et al. Abacavir, zidovudine, or stavudine as paediatric tablets for African HIVinfected children (CHAPAS-3): an open-label, parallel-group, randomised controlled trial. Lancet Infect Dis. 2016;16(2):169–79.

WHO. Guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. 2010.

WHO. Consolidated guidelines on the use of antiretroviral drugs
for treating and preventing

HIV infection: Recommendations for a public health approach
(second edition). 2016

Projects: Children with HIV in Africa Pharmacokinetics and Adherence of Simple Antiretroviral Regimens (CHAPAS): CHAPAS-1 and -3

Project lead: Professor Chifumbe Chintu, University Teaching Hospital, Zambia (CHAPAS-1); Dr Veronica Mulenga, University Teaching Hospital, Zambia (CHAPAS-3)

Target population(s): Children with HIV

Sample size: 71 (CHAPAS-1); 480 (CHAPAS-3)

Countries involved: Ireland, the Netherlands, the UK, the USA, Zambia (CHAPAS-1); Uganda, Zambia (CHAPAS-3)

Project duration: 2005–2009 (CHAPAS-1); 2010 –2011 (CHAPAS-3)

EDCTP funding: €1.2M (CHAPAS-1); €4.6M (CHAPAS-3)

Total project funding: €1.2M (CHAPAS-1); €5.0M