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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

Increasing numbers of clinical trials are taking place in sub-Saharan Africa. Furthermore, the complexity of many of these trials is also on the rise. These developments pose a challenge to national ethics committees, which need to stay abreast of emerging ethical considerations as well as ensuring they operate efficiently.

Ensuring that ethics review committees are fit for purpose can be a particular challenge in French-speaking countries, as many support resources and training materials are produced in English.

The AFREENET project is bringing together three French-speaking countries in sub-Saharan Africa – Benin, Côte d’Ivoire and Guinea – to support joint development of national ethics review capacities, drawing on the expertise of French-speaking European partners.

One key aim is to update working practices, with the adoption of revised standard operating procedures and internationally validated working methods. In the first year of the project, new IT and other equipment was purchased and additional support staff were recruited to ensure that the three national ethics committees were better able to carry out their duties.

The project is also undertaking activities to build the capacities of national ethics committees, in areas spanning basic ethics to more specific emerging issues. Extensive training sessions, lasting three and a half days, have taken place in each country, including practical exercises, all delivered in French. New mechanisms are being established to support longer-term training of committee members, including development of a pool of ethics trainers. The project aims to establish a training pathway to systematically build the skills of new committee members.

The project is also creating national and international networking structures to support greater sharing of experience and expertise. Awareness of the roles and activities of national ethics committees is also being raised among researchers, research institutes, regulators, international agencies and other stakeholders.

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 AFREENET project has supported the collaborative development of national ethics committee capacity in three French-speaking countries, avoiding duplication of efforts and enabling countries to learn from each other as well as from European partners.

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