Publications

Funding for clinical research |drugs, vaccines, microbicides, diagnostics | HIV/AIDS, tuberculosis, malaria, other infectious diseases |sub-Saharan Africa

Dr Nneka Onyejepu

Nigeria

EDCTP portfolio: Clinical Research & Development Fellowships

Dr Nneka Onyejepu aims to become proficient in clinical trial design and management with a view to build a clinical trial support unit at the Nigerian Institute of Medical Research.

Building a clinical trial support unit

Sub-Saharan Africa bears a disproportionate burden of tuberculosis (TB), multidrug (MDR)/extensively drug (XDR) TB, human immunodeficiency virus (HIV) and other poverty-related diseases.

Intervention efforts for poverty-related diseases are focused on research and development of new drug regimens, vaccines and diagnostics, some presently undergoing clinical trials in various continents including Africa. Most African researchers, however, are rarely involved in the early stages of product development and the design of clinical trials. They are more likely to be involved in the implementation phase of effectiveness trials.

In order to develop a mutually beneficial research partnership, African researchers must develop the capacity to design clinical trials, develop protocols and implement all phases of clinical trials.

The challenge

Dr Onyejepu is confident that the Clinical Research and Product Development Fellowship will offer her the opportunity to increase her competencies and prepare her for assuming leading roles in clinical trial processes from design to protocol development, implementation and manuscript writing.

After the placement, the so-called re-integration period at the Nigerian Institute of Medical Research will focus on the development of human resources through training and mentorship. Moreover, advocacy for institutional management buy-in will be pursued, involving various interest groups such as co-researchers the home institution and other tertiary institutions of tertiary education and networks of non-governmental and civil society organisations.

The project

One anticipated outcome is the formation of a Clinical Trial Unit that will offer support for future trials and research within and outside the Nigerian Institute of Medical Research, following international standards. Over time, this will also create career paths for the fellow and other young researchers in Nigeria.

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

Sub-Saharan Africa bears a disproportionate burden of tuberculosis (TB), multidrug (MDR)/extensively drug (XDR) TB, human immunodeficiency virus (HIV) and other poverty-related diseases.

Intervention efforts for poverty-related diseases are focused on research and development of new drug regimens, vaccines and diagnostics, some presently undergoing clinical trials in various continents including Africa. Most African researchers, however, are rarely involved in the early stages of product development and the design of clinical trials. They are more likely to be involved in the implementation phase of effectiveness trials.

In order to develop a mutually beneficial research partnership, African researchers must develop the capacity to design clinical trials, develop protocols and implement all phases of clinical trials.

Dr Onyejepu is confident that the Clinical Research and Product Development Fellowship will offer her the opportunity to increase her competencies and prepare her for assuming leading roles in clinical trial processes from design to protocol development, implementation and manuscript writing.

After the placement, the so-called re-integration period at the Nigerian Institute of Medical Research will focus on the development of human resources through training and mentorship. Moreover, advocacy for institutional management buy-in will be pursued, involving various interest groups such as co-researchers the home institution and other tertiary institutions of tertiary education and networks of non-governmental and civil society organisations.

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.

One anticipated outcome is the formation of a Clinical Trial Unit that will offer support for future trials and research within and outside the Nigerian Institute of Medical Research, following international standards. Over time, this will also create career paths for the fellow and other young researchers in Nigeria.

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