EDCTP portfolio: Emerging diseases

The CAPA-CT 2 study is building on past EDCTP investments to enhance Ebola preparedness in a country bordering the Democratic Republic of the Congo.

Boosting Ebola preparedness in Uganda

The 2018/19 Ebola outbreak in the Democratic Republic of the Congo (DRC) has been concentrated in the north-east of the country, an area that shares a border with Uganda.

With an estimated 8–10,000 people crossing the border on market days, there is a significant risk that the outbreak could spread to Uganda, and several cases have been reported. The country has therefore implemented a range of preparedness measures since 2018.

The challenge

The CAPA-CT 2 project will carry out multiple activities to support Ebola preparedness in Uganda, building on the capacity developed by previous EDCTP funding (the CAPA-CT and VirTUAL projects and the EDCTP Senior Fellowship awarded to Dr Michael Walimbwa).

One strand of work will focus on pharmacokinetic studies on an unlicensed drug, remdesivir, being used in the Ebola outbreak as an emergency control measure. Metabolism and distribution of the drug will be monitored in healthy volunteers and people with HIV infections taking antiretroviral therapy, and modelling will be used to determine the most appropriate dose for clinical use.

The project will also strengthen surveillance activities in Uganda. A third strand of work will evaluate a novel capacity-building model to rapidly build local skills in laboratory biosafety and infection prevention and control to improve the management of patients with suspected Ebola infections.

The project

The CAPA-CT 2 project will add to the evidence base on a potentially important new drug therapy for Ebola infections, and contribute to national Ebola preparedness and the development of global health security capacity in Uganda.

Impact


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

Bringing antiretroviral drugs to children

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

The 2018/19 Ebola outbreak in the Democratic Republic of the Congo (DRC) has been concentrated in the north-east of the country, an area that shares a border with Uganda.

With an estimated 8–10,000 people crossing the border on market days, there is a significant risk that the outbreak could spread to Uganda, and several cases have been reported. The country has therefore implemented a range of preparedness measures since 2018.

The CAPA-CT 2 project will carry out multiple activities to support Ebola preparedness in Uganda, building on the capacity developed by previous EDCTP funding (the CAPA-CT and VirTUAL projects and the EDCTP Senior Fellowship awarded to Dr Michael Walimbwa).

One strand of work will focus on pharmacokinetic studies on an unlicensed drug, remdesivir, being used in the Ebola outbreak as an emergency control measure. Metabolism and distribution of the drug will be monitored in healthy volunteers and people with HIV infections taking antiretroviral therapy, and modelling will be used to determine the most appropriate dose for clinical use.

The project will also strengthen surveillance activities in Uganda. A third strand of work will evaluate a novel capacity-building model to rapidly build local skills in laboratory biosafety and infection prevention and control to improve the management of patients with suspected Ebola infections.

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.

The CAPA-CT 2 project will add to the evidence base on a potentially important new drug therapy for Ebola infections, and contribute to national Ebola preparedness and the development of global health security capacity in Uganda.

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

About us

The European & Developing Countries Clinical Trials Partnership (EDCTP) is a public–public partnership between 14 European and 16 African countries, supported by the European Union. EDCTP’s vision is to reduce the individual, social and economic burden of poverty-related infectious diseases by affecting sub-Saharan Africa. EDCTP’s mission is to accelerate the development of new or improved medicinal products for the identification, treatment and prevention of infectious diseases, including emerging and re-emerging diseases, through pre- and postregistration clinical studies, with emphasis on phase II and III clinical trials. Our approach integrates conduct of research with development of African clinical research capacity and networking. The second EDCTP programme is implemented by the EDCTP Association supported under Horizon 2020, the European Union’s Framework Programme for Research and Innovation.

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