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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 in other countries in sub-Saharan Africa, clinical research has been on the increase in Portuguese-speaking countries. Research ethics committees have been established in ministries of health, universities and other research institutions to ensure that the interests of people are protected and research conforms to international standards of ethical practice.

However, research ethics committees in these countries have limited expertise and experience in ethics review of clinical research proposals. In addition, they face the drawback that most training materials and other resources are produced only in English.

The LusoAfro-BioEthics project is uniting three Portuguese-speaking countries – Angola, Cabo Verde and Mozambique – and European partners to support joint and collaborative development of ethics review capabilities.

One key aim is to build the knowledge and expertise of ethics committee members, through a series of specialist workshops. The first two workshops, held in Angola and Cabo Verde, were attended by nearly 50 delegates in total. Online educational resources, on priority topics identified through initial consultations, have been produced in Portuguese.

The project has organised a self-assessment survey of research ethics committees in participating countries, to gain a clearer picture of capacity development needs. It is also focusing on developing administrative practices and promoting efficiency. Guidelines and other documentation are being produced in Portuguese in areas such as informed consent, protocol reviews, standard operating procedures, and assessing the procedures of research ethics committees.

As well as physical meetings, which provide new networking opportunities, an online platform has been developed to support sharing of experience and expertise across the African and Portuguese partners. Notably, the project has also helped to create a new research ethics committee at the University of Cape Verde.

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 LusoAfro-BioEthics project is enabling three Portuguese-speaking countries to jointly develop their research ethics capacities, reducing duplication of efforts, enabling the sharing of experiences, and drawing on the expertise of European partners. It has created a solid platform for the further joint development of capabilities in the three countries.

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