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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

Following several years of socio-economic turmoil, Zimbabwe has entered a period of relative stability. Until recently, the country’s economic difficulties have led to little investment in health systems and health research, but this situation is beginning to change.

The Medical Research Council of Zimbabwe (MRCZ) is responsible for ensuring the ethical conduct of research in the country. Following several years of uncertainty and high staff turnover, it is now stabilising and looking to upgrade its oversight systems and processes, to provide a foundation for an expansion of health research in Zimbabwe. 

ZERCaP is enabling the MRCZ to address the key challenges facing its health research governance systems. For example, the country has not had a standardised clinical trials and health research oversight system, while research ethics committees are at different levels of maturity. Research proposals are still submitted manually, and tools for developing proposals for ethical approval and for conducting site visits are not harmonised.

In collaboration with the Medicines Control Authority of Zimbabwe, which is responsible for monitoring drug safety, and key research ethics committees at higher education institutions, the MRCZ is harmonising policies and guidelines covering oversight of clinical research. A development programme will ensure that new MRCZ staff are better able to support research ethics committees, leading to the creation of at least three centres of excellence in research ethics review.

In addition, an electronic system for receiving, reviewing and approving research proposals is being introduced. This will enhance access to clinical trial information across stakeholders, and feed into a wider database and online platform for sharing health research information.

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 ZERCaP initiative will help to reinvigorate ethical oversight systems in Zimbabwe, creating a platform for future enhancements to ensure consistency with the highest international health research oversight standards. In doing so, it will establish a stronger foundation for the expansion of high-quality and ethically conducted clinical research to address the country’s health challenges.

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