EDCTP portfolio: Clinical Research & Development Fellowships
index
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