EDCTP portfolio: Neglected infectious diseases

The PEOPLE study is exploring a new way to prevent the spread of leprosy, an ancient but neglected tropical disease.

Protecting against leprosy infection

Leprosy, caused by infection with Mycobacterium leprae, is a disfiguring and disabling disease associated with considerable social stigma. Although it can be treated, efforts to eliminate the disease have stalled and new approaches are needed.

One promising option is post-exposure prophylaxis. In this approach, the contacts of people diagnosed with leprosy are pre-emptively treated with anti-leprosy drugs to protect them against infection.

The challenge

The PEOPLE trial is evaluating a range of approaches to post-exposure prophylaxis in Madagascar and the Comoros, two island states in which leprosy is endemic and current control programmes have not succeeded in reducing the numbers of infections.

The trial will compare the impact of three models of post-exposure prophylaxis using rifampicin, a highly effective leprosy drug. Rifampicin will be provided either to household contacts of a person newly diagnosed with leprosy, to all contacts within 100 metres, and to household contacts and nearby contacts with immunologic evidence of M. leprae infection.

The study will start with a consultative phase to assess the best way to implement the study. It will also carry out a molecular genotyping study of M. leprae infections and analyse social networks, to shed light on leprosy transmission patterns and factors affecting them.

The project

The study will reveal whether post-exposure prophylaxis is an effective approach for controlling the spread of leprosy. If it is, policymakers in Madagascar, the Comoros and other African countries in which leprosy is endemic would have a new tool for reinvigorating national leprosy control programmes.

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, caused by infection with Mycobacterium leprae, is a disfiguring and disabling disease associated with considerable social stigma. Although it can be treated, efforts to eliminate the disease have stalled and new approaches are needed.

One promising option is post-exposure prophylaxis. In this approach, the contacts of people diagnosed with leprosy are pre-emptively treated with anti-leprosy drugs to protect them against infection.

The PEOPLE trial is evaluating a range of approaches to post-exposure prophylaxis in Madagascar and the Comoros, two island states in which leprosy is endemic and current control programmes have not succeeded in reducing the numbers of infections.

The trial will compare the impact of three models of post-exposure prophylaxis using rifampicin, a highly effective leprosy drug. Rifampicin will be provided either to household contacts of a person newly diagnosed with leprosy, to all contacts within 100 metres, and to household contacts and nearby contacts with immunologic evidence of M. leprae infection.

The study will start with a consultative phase to assess the best way to implement the study. It will also carry out a molecular genotyping study of M. leprae infections and analyse social networks, to shed light on leprosy transmission patterns and factors affecting them.

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 study will reveal whether post-exposure prophylaxis is an effective approach for controlling the spread of leprosy. If it is, policymakers in Madagascar, the Comoros and other African countries in which leprosy is endemic would have a new tool for reinvigorating national leprosy control programmes.

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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