EDCTP portfolio: Neglected infectious diseases

The PEP4LEP study is comparing two possible approaches for screening and pre-emptively treating those at risk of leprosy infections.

Limiting the spread of leprosy

Leprosy is a chronic infection affecting the skin and nerves, and loss of sensation can lead to tissue damage in areas such as the hands and feet. Affecting much of Africa, it is associated with considerable social stigmatisation.

Single-dose rifampicin is used to prevent infection in those exposed to people with leprosy infections. A major challenge is to identify the best way to deliver preventive treatments.

The challenge

The PEP4LEP project is a highly practical implementation study comparing two possible approaches for screening and identifying people at risk of developing leprosy.

It will carry out a randomised implementation trial comparing two possible strategies. One will be community based: ‘skin camps’ will be set up to screen around 100 people likely to have been in contact with a leprosy patient. The second approach will be focused on health facilities, with contacts invited to attend screening sessions. Both approaches will include wider dermatological assessments to identify common skin conditions and neglected infectious diseases affecting the skin.

The study will determine which is the better model for detecting new infections and reducing delays in detection. It will also explore community acceptability and cost-effectiveness.

The project

The PEP4LEP project will provide policymakers with highly relevant information on the effectiveness and cost-effectiveness of two methods for improved leprosy control, ultimately ensuring that more people benefit from an intervention of proven efficacy.

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

Leprosy is a chronic infection affecting the skin and nerves, and loss of sensation can lead to tissue damage in areas such as the hands and feet. Affecting much of Africa, it is associated with considerable social stigmatisation.

Single-dose rifampicin is used to prevent infection in those exposed to people with leprosy infections. A major challenge is to identify the best way to deliver preventive treatments.

The PEP4LEP project is a highly practical implementation study comparing two possible approaches for screening and identifying people at risk of developing leprosy.

It will carry out a randomised implementation trial comparing two possible strategies. One will be community based: ‘skin camps’ will be set up to screen around 100 people likely to have been in contact with a leprosy patient. The second approach will be focused on health facilities, with contacts invited to attend screening sessions. Both approaches will include wider dermatological assessments to identify common skin conditions and neglected infectious diseases affecting the skin.

The study will determine which is the better model for detecting new infections and reducing delays in detection. It will also explore community acceptability and cost-effectiveness.

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 PEP4LEP project will provide policymakers with highly relevant information on the effectiveness and cost-effectiveness of two methods for improved leprosy control, ultimately ensuring that more people benefit from an intervention of proven efficacy.

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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