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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

For sub-Saharan African countries to develop and implement a health research agenda responsive to their needs, they need to ensure that they sustain an environment conducive to high-quality clinical research. 

Given the increasing number and complexity of clinical research proposals, it is essential that countries have sufficient numbers of individuals with the expertise to review clinical research proposals, across all relevant disciplines.  

The BRECOR project is bringing together a range of international partners from Europe and sub-Saharan Africa to enhance the human and infrastructural capacity for regulation and ethical review of clinical research proposals in Rwanda. It will work with the key bodies involved in such review, including institutional review boards, which carry out an initial assessment of proposals, and the Rwanda National Ethics Committee, which approves all clinical trials in the country, as well as the Rwanda Food and Drug Authority (FDA).

As well as strengthening core national ethical review functions, the project will deliver hands-on training to ensure that members of Rwanda’s eight institutional review boards have sufficient breadth of expertise and skills to effectively review the design, plans and feasibility of proposed clinical studies.

The project also aims to improve the efficiency of national systems, for example by introducing into the National Ethics Committee the RHInnO Ethics online system for submission, review and approval of protocols, as well as a paperless document and information management system. It also aims to improve oversight of ongoing projects through training of staff from the National Ethics Committee, institutional review boards and the FDA on clinical trial assessment and monitoring by clinical quality assurance experts.

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 BRECOR project will strengthen regulatory and ethics review capacity in Rwanda, ensuring effective protection of the interests of participants and providing a supportive environment for clinical studies addressing key local health issues.

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