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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

As increasing numbers of medical products are evaluated in clinical trials and introduced in African countries, there is a growing need to ensure that effective systems are in place to regulate clinical studies and to monitor for potential adverse events. To date, these aspects of health systems have not received the attention they merit.

Similar challenges are faced by all countries, and there are opportunities for different countries to share experiences, learn from each other and coordinate efforts to develop their national regulatory systems.   

The SPaRCS project is supporting coordinated development of regulatory capacity in four southern African states – Eswatini, Namibia, South Africa and Zimbabwe. It has a particular focus on regulation of clinical trials and drug safety monitoring (pharmacovigilance).

The project is encouraging collaborations between regulatory agencies and academia and across the four countries, helping to establish sustainable relationships and a community of practice that will last beyond the project. In the first phase of the project, regulatory structures, personnel, activities and reporting systems are being mapped in each of the countries, using a participatory approach.

The results of this mapping exercise will feed into a second phase exploring opportunities for mutual learning across the four national regulatory authorities, including exchange visits and topic-specific workshops. In the final phase, local experts and education institutes will be involved in the development of educational materials to enhance the capacity of health professionals in pharmacovigilance and adverse event reporting. 

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 SPaRCS project will enhance the personnel and institutional capacities of the national regulatory authorities in the four countries, through increased connectivity, reciprocal learning and a community of practice that will support further reflective practice and collaborative learning into the future.

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