EDCTP portfolio: Neglected infectious diseases

The FREEBILY study is accelerating the development of schistosome diagnostics for pregnant women and young children.

Rapid detection of schistosome infections

Among parasites, schistosomes (flatworms) are second only to malaria in terms of their health and socioeconomic impact. Around 700 million people live in countries where schistosomiasis occurs, and 90% of those requiring treatment live in Africa.

Control of schistosomiasis relies mainly on mass drug administration with praziquantel. As the condition becomes less common, there is an increasing need for accurate diagnostics to support more targeted strategies. In particular, diagnostics could ensure that vulnerable groups, such as pregnant women and young children, are not unnecessarily exposed to praziquantel.

The challenge

Diagnostic tests have been developed to detect schistosome infections. The point-of-care POC-CCA test is good for detecting intestinal schistosomiasis but has lower sensitivity for urinary schistosomiasis. By contrast, the UCP-LF test is highly sensitive and specific but requires laboratory facilities.

The FREEBILY project is evaluating the use of these tests to detect schistosome infections in women and young children in different contexts. One application being assessed is use of the POC-CCA test in routine mother and child clinics, to support ‘test and treat’ strategies.

The project is also evaluating use of the UCP-LF test to detect S. haematobium and provide an accurate measure of praziquantel efficacy in a trial of praziquantel use in pregnant women in Gabon.

The project

FREEBILY will provide evidence on the effectiveness and cost-effectiveness of test-and-treat strategies for schistosomiasis in pregnant women and young children, as well as additional data on the UCP-LF test. Although the studies are being conducted in areas of high and low schistosome endemicity in Madagascar and Gabon, the results will be generalisable to other countries affected by schistosomiasis.

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

Among parasites, schistosomes (flatworms) are second only to malaria in terms of their health and socioeconomic impact. Around 700 million people live in countries where schistosomiasis occurs, and 90% of those requiring treatment live in Africa.

Control of schistosomiasis relies mainly on mass drug administration with praziquantel. As the condition becomes less common, there is an increasing need for accurate diagnostics to support more targeted strategies. In particular, diagnostics could ensure that vulnerable groups, such as pregnant women and young children, are not unnecessarily exposed to praziquantel.

Diagnostic tests have been developed to detect schistosome infections. The point-of-care POC-CCA test is good for detecting intestinal schistosomiasis but has lower sensitivity for urinary schistosomiasis. By contrast, the UCP-LF test is highly sensitive and specific but requires laboratory facilities.

The FREEBILY project is evaluating the use of these tests to detect schistosome infections in women and young children in different contexts. One application being assessed is use of the POC-CCA test in routine mother and child clinics, to support ‘test and treat’ strategies.

The project is also evaluating use of the UCP-LF test to detect S. haematobium and provide an accurate measure of praziquantel efficacy in a trial of praziquantel use in pregnant women in Gabon.

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.

FREEBILY will provide evidence on the effectiveness and cost-effectiveness of test-and-treat strategies for schistosomiasis in pregnant women and young children, as well as additional data on the UCP-LF test. Although the studies are being conducted in areas of high and low schistosome endemicity in Madagascar and Gabon, the results will be generalisable to other countries affected by schistosomiasis.

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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