EDCTP portfolio: Emerging diseases

The PEAU-EBOV-RDC study is building the capacity of the Democratic Republic of the Congo to evaluate new diagnostics and treatments for Ebola, to reduce very high fatality rates.

Improving care of Ebola patients

Fatality rates in Ebola outbreaks in the Democratic Republic of the Congo (DRC) have been very high – two-thirds of people with infections have died. There is some evidence that early diagnosis and high-quality patient management can improve survival rates.

In addition, a range of new diagnostics and treatments have been developed since the West Africa Ebola outbreak. They may aid survival, but their performance and effectiveness can only be truly tested in outbreak situations.

The challenge

The PEAU-EBOV-RDC project is carrying out a range of activities to improve the care of patients with Ebola infections, by enhancing the quality of supportive care and by evaluating new diagnostics and treatments.

The DRC’s national public health laboratory, l’Institut National de Recherche Biomédicale, has the responsibility for coordinating research on experimental emergency interventions for Ebola, and has developed an Ebola viral disease research plan. The PEAU-EBOV-RDC project will support a key aim of this plan, strengthening national capacities to undertake trials of experimental treatments and to collect and use high-quality safety data. It will also support the national priority of strengthening capacity to handle suspected Ebola samples and diagnose infections.

The project has been developed in partnership with an existing EDCTP-funded network building epidemic preparedness capacities in sub-Saharan Africa, the African Coalition for Epidemic Research, Response and Training (ALERRT). 

The project

The PEAU-EBOV-RDC project will play a key role in supporting the development of research capacities in the DRC, ultimately identifying approaches that enhance the survival of patients with Ebola infections.

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

Fatality rates in Ebola outbreaks in the Democratic Republic of the Congo (DRC) have been very high – two-thirds of people with infections have died. There is some evidence that early diagnosis and high-quality patient management can improve survival rates.

In addition, a range of new diagnostics and treatments have been developed since the West Africa Ebola outbreak. They may aid survival, but their performance and effectiveness can only be truly tested in outbreak situations.

The PEAU-EBOV-RDC project is carrying out a range of activities to improve the care of patients with Ebola infections, by enhancing the quality of supportive care and by evaluating new diagnostics and treatments.

The DRC’s national public health laboratory, l’Institut National de Recherche Biomédicale, has the responsibility for coordinating research on experimental emergency interventions for Ebola, and has developed an Ebola viral disease research plan. The PEAU-EBOV-RDC project will support a key aim of this plan, strengthening national capacities to undertake trials of experimental treatments and to collect and use high-quality safety data. It will also support the national priority of strengthening capacity to handle suspected Ebola samples and diagnose infections.

The project has been developed in partnership with an existing EDCTP-funded network building epidemic preparedness capacities in sub-Saharan Africa, the African Coalition for Epidemic Research, Response and Training (ALERRT). 

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 PEAU-EBOV-RDC project will play a key role in supporting the development of research capacities in the DRC, ultimately identifying approaches that enhance the survival of patients with Ebola infections.

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.

Contact us

For more information, please contact us or leave a message using this form.
Please enter your name
Please enter a correct e-mail address
Please enter a comment
Thank you! Your message has been sent.
Something went wrong while submitting the form. Try again.

Share this publication

Forward this page by e-mail or share it directly on social media.

Search

Enter a search term to search the EDCTP publications.
Minimal length to search is 3 characters

This publication uses cookies

We use functional and analytical cookies to improve our website. In addition, third parties place tracking cookies to display personalised advertisements on social media. By clicking accept you consent to the placement of these cookies.