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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

Research ethics committees are essential for reviewing clinical research proposals and ensuring that projects conform to high ethical standards. The growth of clinical research in sub-Saharan Africa, and increasing complexity in the range of ethical issues that need to be considered, is placing strains on many countries’ infrastructure for ethics review.

In Kenya, research ethics committees are accredited by the National Commission for Science, Technology and Innovation (NACOSTI), through its National Bioethics Committee. The number of accredited research ethics committees has increased from five in 2009 to 25 in 2018.

Through the STReK project, the University of Nairobi is working in collaboration with NACOSTI and the National Bioethics Committee to improve the efficiency of the Committee and to strengthen the capacity of members of both the National Committee and institutional research ethics committees in the country to undertake ethics review.

The project has facilitated the development of a new strategic plan for the National Bioethics Committee, based on extensive consultation among stakeholders. To support more effective working and streamlining of its operations, the project has helped to develop a set of revised standard operating procedures for the National Bioethics Committee. These will provide templates for use by research ethics committees across the country.

With support from the STReK project, the National Bioethics Committee is also enhancing its IT infrastructure for monitoring research ethics committees and creating a database of committee members to support networking and consultation. 

A research ethics training package is being developed and will be delivered to at least 120 committee members. A structured mentorship programme is also being introduced, including placements at mentor sites, for 22 research ethics committee members. At the end of the project, NACOSTI will organise a research ethics conference to promote networking, sharing of experience and benchmarking, with invitations extended to other national bioethics committees in East Africa and at least one EU research ethics committee.

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 STReK project is strengthening connections between academia and a key regulatory body in Kenya, to improve the efficiency and quality of ethics review processes in the country. It will help to ensure that the country remains an attractive country in which to carry out clinical research and has the capacity to increase the volume of research undertaken.

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