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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

National regulatory agencies have a critical public health role to play in protecting populations, during clinical trials and when new medicines are licensed and introduced.

In Cameroon, regulation of clinical research is the responsibility of the Division of Health Operational Research in the Ministry of Health. The Division sets up research ethics committees and works closely with the Cameroon National Ethics Committee, which reviews clinical research proposals. The Directorate of Pharmacy, Laboratory and Drugs is responsible for drug safety monitoring (pharmacovigilance). However, although policies and infrastructures exist for regulation of clinical research and pharmacovigilance, these are not widely enforced.  

The BREEDSAFCA project is strengthening national systems for ethics review of research and pharmacovigilance in Cameroon. Commissions are being set up to examine and revise existing regulations of ethics review and pharmacovigilance and to suggest new regulations where they are needed. The performance of bodies involved in these areas will be evaluated and plans developed to enhance their activities where required.

The project will support the set up of new ethics committees at two universities in two regions in Cameroon. It will also help to establish pharmacovigilance units for two new health programmes and in one new region of the country.

In the first year of the project, a review was undertaken of existing regulations covering research involving human participants, and a need was identified for two new regulatory guidelines. Key texts relevant to pharmacovigilance have also been collated, and will also be reviewed to identify the need for updating. In addition, a questionnaire has been developed that will be used to assess training needs among research ethics committee members, researchers involved in clinical studies in Cameroon, and staff in pharmacovigilance units.

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 BREEDSAFCA project will build capacity in Cameroon in two key areas – ethics review of clinical research protocols and safety monitoring for drugs and other medical interventions, such as vaccines. In doing so, it will strengthen the protection provided to participants in clinical research in Cameroon, and protect public health more generally by improving monitoring and investigation of potential adverse reactions to drugs and vaccines.

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