EDCTP portfolio: Clinical Research & Development Fellowships

Dr Micah Ongeri aims to acquire essential clinical research skills including advanced laboratory skills and train laboratory scientists and technicians at the University of Nairobi.

Advanced laboratory skills at IAVI

Through a 12-month placement at the International Aids Vaccine Initiative (IAVI), Dr Ongeri challenges himself to learn the process of developing and implementing new laboratory tests (diagnostics) and acquire practical experience in clinical trial design and implementation.

The challenge

The specific objectives of Dr Ongeri’s fellowship are several. First, he will contribute to increasing laboratory capacity in clinical trial research through his training in advanced laboratory skills. These will include hands-on training on viral inhibition assay, viral neutralisation assay and ELISPOT assay, validation of diagnostics, and implementing quality systems (GCLP compliance, quality control and quality control safety), laboratory data management and other laboratory protocols important for product (vaccine/drug) evaluation. Secondly, he will acquire practical experience in the conduct of a clinical trial in a multi-country, multi-cultural environment.

In the reintegration period at the University of Nairobi, he will share the acquired skills and knowledge through training initiatives, mentorship and supervision activities, as well as through scientific workshops and seminars at his home organisation. He will develop training materials and training certificates for the participants who attended and completed the courses offered in the context of his reintegration activities.

The project

The fellowship will boost the technical laboratory and clinical trial expertise of Dr Ongeri. At least 40 laboratory scientists and technicians will be trained in the relevant clinical trials skills and knowledge acquired during the fellowship.

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

Through a 12-month placement at the International Aids Vaccine Initiative (IAVI), Dr Ongeri challenges himself to learn the process of developing and implementing new laboratory tests (diagnostics) and acquire practical experience in clinical trial design and implementation.

The specific objectives of Dr Ongeri’s fellowship are several. First, he will contribute to increasing laboratory capacity in clinical trial research through his training in advanced laboratory skills. These will include hands-on training on viral inhibition assay, viral neutralisation assay and ELISPOT assay, validation of diagnostics, and implementing quality systems (GCLP compliance, quality control and quality control safety), laboratory data management and other laboratory protocols important for product (vaccine/drug) evaluation. Secondly, he will acquire practical experience in the conduct of a clinical trial in a multi-country, multi-cultural environment.

In the reintegration period at the University of Nairobi, he will share the acquired skills and knowledge through training initiatives, mentorship and supervision activities, as well as through scientific workshops and seminars at his home organisation. He will develop training materials and training certificates for the participants who attended and completed the courses offered in the context of his reintegration activities.

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 fellowship will boost the technical laboratory and clinical trial expertise of Dr Ongeri. At least 40 laboratory scientists and technicians will be trained in the relevant clinical trials skills and knowledge acquired during the fellowship.

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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