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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

Despite the size of its population, sub-Saharan Africa hosts only a small proportion of the world’s clinical trials. Even within sub-Saharan Africa, countries in Central Africa carry out relatively little clinical research. 

Several initiatives have aimed to build capacity for clinical trials in Africa, and in Central Africa specifically. The EDCTP-funded Central African Network on Tuberculosis, HIV/AIDS and Malaria (CANTAM) network (http://www.cantam.org), for example, has done much to develop individual and institutional capacity for research. However, further progress is being held back by limited regulatory and ethics review capacity in Central African countries

The Africlinique project is strengthening the capacity of the national regulatory authorities of Cameroon and the Republic of the Congo. It is based on the creation of a collaborative network encompassing Central African and European national regulatory authorities as well as CANTAM and bodies such as the African Vaccine Regulatory Forum (AVAREF).

Through the project, the partners will collectively develop an action plan for implementation of new standard operating procedures, harmonised guidelines, training programmes and drug safety monitoring mechanisms. The network will also facilitate ongoing communication and education across partners.

The project is also developing a joint advocacy campaign highlighting the opportunities for clinical research in Central Africa, to raise awareness of the economic and societal benefits of clinical trials in the region, and to encourage clinical research organisations to consider Central Africa as a site for studies.

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 Africlinique project will create a sustainable European–African collaborative network that will strengthen regulatory and pharmacovigilance capacity in Central Africa, and establish efficient and harmonised approaches for regulation. It will help to nurture a more attractive environment for clinical research initially in Cameroon and the Republic of the Congo, and potentially also in other Central African countries which have the opportunity to join the collaboration.

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