“
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 pertains to this type of fellowship, Dr Zemsi Kala aims to acquire knowledge and practical expertise in many aspects of the setup and conduct of clinical trials in sub-Saharan Africa, e.g. with a view to identifying gaps in regulatory and clinical capacities.

In addition to his routine clinical activities as a general practitioner, Dr Kala has been contributing as a sub-investigator in various research programs and health promotion activities in the fields of HIV and tuberculosis at his institution in Cameroon. He has also been involved at site level in the planning, set-up and conduct of a GSK-funded Ebola vaccine trial.

The aim of the project is to complement his experience in implementing health and research projects in resource-constrained settings, with better knowledge of study design, regulatory requirements and trial reporting.

He seeks to learn how to proactively identify gaps and corresponding investments to be made in terms of the regulatory framework, capacity building (infrastructure/resources) and evaluate the operational readiness of investigational sites in different countries. He wants to gain expertise in the management of complex multi-country trials and learn various aspects of a clinical trial from protocol design to clinical study reporting.

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.

After the placement period, for six months Dr Kala focused on the so-called reintegration activities of the clinical R&D fellowships at his home institution. He organised a 4 days training workshop on research methodology for 60 medical students. Furthermore, he designed and implemented two research projects in collaboration with two medical students as mentees. Finally, he set up an online forum on which junior researchers can discuss issues they face in their projects with more experienced researchers.

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