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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

Clinical research activities are growing rapidly in sub-Saharan Africa, with infectious disease a major focus of research. The complexity of clinical studies is also increasing as new types of trial design and new experimental approaches are developed.

For countries to benefit from these innovations, effective systems for regulation of clinical research are required, to protect populations while also facilitating research with the potential to benefit such populations. National systems must have the expertise and capacity to handle growing volumes of increasingly complex research.

The HATUA project (‘hatua’ means ‘action’ in Swahili) aims to enhance the technical capacity of Kenyan regulatory bodies and selected high-volume institutional research ethics committees. Its goals are to strengthen oversight at a national level and enhance the performance of institutional bodies, as well as to improve coordination between regulators and institutional research ethics committees and across different committees.

The project is working closely with Kenya’s national regulatory agency, the Pharmacy and Poisons Board, and the National Commission for Science, Technology and Innovation (NACOSTI), which is responsible for approving all clinical research in Kenya and accreditation of institutional research ethics committees.

The project’s focus is on ‘three Cs’: compliance, capacity building and community building. For compliance, a capacity needs assessment was carried out to inform the development of shared online platforms at national and institutional levels. This has included systems for pharmacovigilance reporting, clinical trial registration, and research institution registration. The online RHInnO Ethics system for protocol submission and review is being introduced at both national and institutional levels.

Capacity is being built through master’s training in bioethics for six students, as well as short-term training for research administrators and staff supporting the work of institutional research ethics committees. Community-building activities have included several workshops and other events organised in collaboration with the Bioethics Society of Kenya, to support sharing of experiences across institutions and discussion of topical ethical issues.

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 HATUA project will strengthen ethical review capacity in Kenya, enabling it to consolidate its position as one of the leading countries for health research in sub-Saharan Africa.

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