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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

The number of applications for clinical research has risen nearly tenfold in Sierra Leone over the past decade. The complexity of applications has also increased, with research proposed on vulnerable populations, high-risk pathogens, and novel therapeutics and diagnostics.

At the same time, Sierra Leone is still recovering from the impact of the 2014–16 West Africa Ebola outbreak, and has limited capacity to manage these increasing demands effectively.   

The SERCLe project is strengthening ethics and regulatory governance and practice in Sierra Leone, focusing on its national ethics committee, the Sierra Leone Ethics and Scientific Review Committee, and its national regulatory authority, the Pharmacy Board of Sierra Leone.

The project is undertaking a baseline assessment of institutional capacities, which will be used as the basis for the development of collaborative action plans to address key gaps. Priority areas will include governance mechanisms, including policy, guidelines and standard operating procedures, improving collaboration between the Ethics and Scientific Review Committee and the Pharmacy Board, strengthening links with regional and international organisations, developing the technical capacity of individuals, and building institutional capacity to undertake additional training in ethics review and regulatory oversight of clinical research.

The project will also extend links to other sources of expertise, including the Regional Centre of Regulatory Excellence in Ghana, the WHO Collaborating Centre for International Drug Monitoring in Uppsala, Sweden, the Council on Health Research for Development (COHRED), and the African Vaccines Regulatory Forum (AVAREF). 

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 SERCLe project will build upon existing successful collaborations between Sierra Leone and Europe, drawing on European and African centres of excellence to strengthen the ethics review and regulatory capacity of Sierra Leone. Alongside other capacity-building initiatives, it will create a more favourable environment for research on Ebola and other priority infectious diseases.

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