EDCTP portfolio: Neglected infectious diseases

EDCTP has joined forces with a Japanese funding agency to progress a young children’s version of a drug treatment for schistosomiasis, a common and debilitating parasitic disease.

Partnering up in the battle against parasitic infections

Schistosomiasis, a neglected infectious disease caused by parasitic flatworms, affects around 250,000 people a year, most of them in Africa. It causes a variety of symptoms, including abdominal pain and diarrhoea, and may lead to more serious organ damage and even death. In children, infections interfere with growth and development, and therefore have lifelong impact.

Schistosomiasis can be treated with a drug known as praziquantel. However, currently used praziquantel pills are difficult for young children to swallow, cannot be crushed, and have an unpleasant bitter taste.

The challenge

The Pediatric Praziquantel Consortium, funded primarily by the Japan-based Global Health Innovative Technology Fund (GHIT), has developed a new praziquantel pill that dissolves in the mouth, making it easier to give to young children. In partnership with EDCTP, the Consortium will undertake one clinical trial to test the safety and efficacy of this new formulation in young children in Cote d’Ivoire and Kenya. The trial will be carried out to international regulatory standards, so that their results can feed directly into submissions to regulatory agencies and the new pills can rapidly be made available to young children.

The project

The new formulation will enable more young children to gain the benefits of praziquantel – potentially both for treatment and in mass drug administration campaigns to prevent infections. More generally, the project is the first outcome of an ongoing partnership between EDCTP and GHIT, organisations with common interests in HIV/AIDS, malaria, TB and poverty-related infectious diseases.

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

Schistosomiasis, a neglected infectious disease caused by parasitic flatworms, affects around 250,000 people a year, most of them in Africa. It causes a variety of symptoms, including abdominal pain and diarrhoea, and may lead to more serious organ damage and even death. In children, infections interfere with growth and development, and therefore have lifelong impact.

Schistosomiasis can be treated with a drug known as praziquantel. However, currently used praziquantel pills are difficult for young children to swallow, cannot be crushed, and have an unpleasant bitter taste.

The Pediatric Praziquantel Consortium, funded primarily by the Japan-based Global Health Innovative Technology Fund (GHIT), has developed a new praziquantel pill that dissolves in the mouth, making it easier to give to young children. In partnership with EDCTP, the Consortium will undertake one clinical trial to test the safety and efficacy of this new formulation in young children in Cote d’Ivoire and Kenya. The trial will be carried out to international regulatory standards, so that their results can feed directly into submissions to regulatory agencies and the new pills can rapidly be made available to young children.

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 new formulation will enable more young children to gain the benefits of praziquantel – potentially both for treatment and in mass drug administration campaigns to prevent infections. More generally, the project is the first outcome of an ongoing partnership between EDCTP and GHIT, organisations with common interests in HIV/AIDS, malaria, TB and poverty-related infectious diseases.

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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