Dr Dawit Wolday

Ethiopia

EDCTP portfolio: Senior Fellowships

Dr Dawit Wolday is evaluating two new options for rapid and simplified diagnosis of visceral leishmaniasis, an important neglected infectious disease in East Africa.

Rapid diagnosis of visceral leishmaniasis

An estimated 350 million people are at risk of developing leishmaniasis, infection with the single-celled Leishmania parasite. The most severe form of the disease, visceral leishmaniasis or kala azar, is particularly common in East Africa.

Treatment and control would benefit greatly from reliable point-of-care diagnostics to detect new infections as well as ‘test-of-cure’ tools to assess the success of treatment. However, methods to detect parasites or antibodies against Leishmania are either not available in East Africa or perform poorly, especially in people living with HIV. Although molecular tests show excellent performance, they require specialist training and facilities and are expensive.

The challenge

In his EDCTP Senior Fellowship, Dr Dawit Wolday is evaluating two possible alternative methods for diagnosing new Leishmania infections and for monitoring treatment responses.

The first is based on a method for amplification of parasite DNA that does not require repeated cycles of heating and cooling, central to conventional tools based on the polymerase chain reaction (PCR). Loop-mediated isothermal amplification (LAMP) methods show good specificity, generate easy-to-interpret results and require no cold chain. However, despite this promise, there are few data on their use in Africa.

Dr Wolday will also evaluate a novel PCR-based test, known as db-PCR-NALFIA, which can be used directly on blood samples without the need for extraction of DNA.

The project

Dr Wolday’s Senior Fellowship project will provide key data on two new point-of-care tools for diagnosing visceral leishmaniasis and for monitoring patient responses and test of cure. The two tools will be tested in people with and without HIV, and results compared with rigorous laboratory-based assessments.

The results will provide policymakers in Ethiopia and other East African countries with key evidence of the effectiveness of the new tests. The project will also build capacity in research on neglected infectious diseases at Mekelle University College of Health Sciences in Ethiopia, including the training of two master’s and one PhD student.

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

An estimated 350 million people are at risk of developing leishmaniasis, infection with the single-celled Leishmania parasite. The most severe form of the disease, visceral leishmaniasis or kala azar, is particularly common in East Africa.

Treatment and control would benefit greatly from reliable point-of-care diagnostics to detect new infections as well as ‘test-of-cure’ tools to assess the success of treatment. However, methods to detect parasites or antibodies against Leishmania are either not available in East Africa or perform poorly, especially in people living with HIV. Although molecular tests show excellent performance, they require specialist training and facilities and are expensive.

In his EDCTP Senior Fellowship, Dr Dawit Wolday is evaluating two possible alternative methods for diagnosing new Leishmania infections and for monitoring treatment responses.

The first is based on a method for amplification of parasite DNA that does not require repeated cycles of heating and cooling, central to conventional tools based on the polymerase chain reaction (PCR). Loop-mediated isothermal amplification (LAMP) methods show good specificity, generate easy-to-interpret results and require no cold chain. However, despite this promise, there are few data on their use in Africa.

Dr Wolday will also evaluate a novel PCR-based test, known as db-PCR-NALFIA, which can be used directly on blood samples without the need for extraction of DNA.

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.

Dr Wolday’s Senior Fellowship project will provide key data on two new point-of-care tools for diagnosing visceral leishmaniasis and for monitoring patient responses and test of cure. The two tools will be tested in people with and without HIV, and results compared with rigorous laboratory-based assessments.

The results will provide policymakers in Ethiopia and other East African countries with key evidence of the effectiveness of the new tests. The project will also build capacity in research on neglected infectious diseases at Mekelle University College of Health Sciences in Ethiopia, including the training of two master’s and one PhD student.

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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