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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

In line with the Ethiopian national strategic plan for research and development, Jimma University is investing heavily in human resource development, physical infrastructure and material resources that will enable the university to conduct rigorous clinical research and policy analyses. This will provide knowledge-based input for policymaking and policy implementation. The university is currently creating an Institute of Pharmaceutical Research and Biotechnology by merging its laboratory for drug quality with the laboratory of molecular biology.

The challenge for the fellow is to support this strategic push by Jimma University to establish, conduct, and support clinical and pharmaceutical research in medicines and biotechnology.

Personally, Dr Kasim, an associate professor of infectious disease engaged in research, teaching, community service and other forms of scholarly activity for more than 10 years at Jimma University, aims to establish himself as an independent investigator and potential leader in the field of infectious disease clinical research with a special emphasis on neglected infectious diseases.

From the fellowship and the placement at Julius Clinical Research BV, the Netherlands, he expects to gain news skills and experience, especially in the design, implementation and management of multidisciplinary trials with a focus on neglected infectious diseases. An important part of every EDCTP Clinical R&D Fellowship is the translation of skills and knowledge to the home institution of the fellow. Dr Kasim developed a plan to apply and disseminate his knowledge by training staff and students in the fields of tropical and infectious disease, medical parasitology and medical microbiology. He aims also to accelerate existing clinical research and plan new collaborative multidisciplinary research targeting the health and wellbeing of the community in Ethiopia. In this way, he will contribute to the establishment of an expanded clinical trial centre as well as contribute to the transformation of the university laboratory to an institute of pharmaceutical research and biotechnology. One of the projects is to improve the quality of the performance of the laboratory for malaria and experimental entomology. 

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 expected impact of this fellowship is a substantial contribution to the strategic project of Jimma University to create and develop an institute of Pharmaceutical Research and Biotechnology with a clinical research centre.

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