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test the safety and efficacy of this new formulation in young children

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Bringing antiretroviral drugs to children

The CHAPAS trials have ensured that many more children with HIV have benefited
from life-saving antiretrovirals.

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