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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

Increasing numbers of clinical trials are being conducted in sub-Saharan Africa. However, such trials raise a number of context-specific ethical issues, including potential research participant who are illiterate and socio-cultural specificities that raise questions about participants’ understanding of how clinical research is conducted.

In addition, countries in West Africa are at risk of infectious disease outbreaks, as illustrated by the devastating 2014–16 Ebola epidemic. In these emergency situations, research needs to be initiated as rapidly as possible, while ensuring that participants’ rights and interests are protected.

The REECAO project is building the capacity of three West African countries – Ghana, Guinea and Mali – to provide effective ethics review of complex clinical studies. It aims to enhance the transparency, governance and coordination of ethics committees, thereby facilitating multicentre international studies.

The project brings together key bodies from participating countries, including national ethics committees, research ethics committees/institutional review boards, and national regulatory agencies. As well as these South–South links, expert input is being provided by Lyon Catholic University, France.

The project has established a network uniting national ethics committees and institutional review boards in the three countries, along with an associated website. This includes a bibliographic database updated every three months with key publications. An email hotline in French and English has also been created to enable ethics committee members to seek expert guidance. An online platform has also been established with standardised guidelines and procedures for protocol submission and review.

The project is implementing a training programme for members of national ethics committees and institutional review boards covering ethical issues related to clinical trials and research on human participants. Training sessions, based on the ‘train the trainer’ model, have been held in each of the three participating countries.

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 REECAO project is ensuring that research ethics committees in the three participating West African countries are equipped to manage complex emerging questions in clinical research, including research in emergency situations. It will enable the countries to respond more effectively and efficiently to clinical research proposals, including those involving international multicentre studies.

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