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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

Ethiopia has a high disease burden for HIV/AIDS, tuberculosis, malaria and human African trypanosomiasis. However, there are very few people in Ethiopia who are highly skilled in clinical research and product development. The main goal of the placement at Merck for Dr Alemayehu, who has already extensive experience as a pharmacologist and university teacher, is to acquire expert knowledge and advanced skills which will enable him to contribute to the structural development of the clinical research and teaching capacity at the University of Addis Ababa, Ethiopia.

The EDCTP R&D Fellowship is to boost an already distinguished career as a pharmacologist, university teacher and mentor of young researchers. Dr Alemayehu graduated with honours from Addis Ababa University and received a PhD in veterinary molecular pharmacology from the University of Leipzig, Germany. He has eighteen years of experience in higher education teaching, research and administration, teaching pharmacology at undergraduate and postgraduate levels and supervising 47 postgraduate MSC students and examining over 75 MSc theses. From 2010 to 2016, he was head of his department. He published over 48 articles in peer-reviewed scientific journals.

In 2014, the University of Addis Ababa awarded him the title of “Emerging Researcher” in recognition of his participation in the research of the College of Health Sciences. In 2016, he received a Mid-Career Track NIH-Fogarty Fellowship for research training through the ‘Ethiopia-Emory Tuberculosis Research Training Program’, which is hosted at the Armauer Hansen Research Institute (Ethiopia) and the Emory University School of Medicine (USA), and supported by the NIH Fogarty International Center. In 2016, he was one of twenty globally selected Novartis Next Generation Scientists and successfully completed a three months research internship with certification by the University of Basel, Switzerland.

The EDCTP R&D Fellowship and placement at Merck will enable him to acquire experience in all elements of clinical research including trial design, operation, implementation, project management, regulation, clinical trial data reporting, medicines development, etc, which will establish him as full-fledged principal investigator for the conduct of clinical trials on infectious diseases in Ethiopia.

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 immediate impact of this fellowship will consist of training workshops at the University of Addis Ababa for junior staff members and postgraduate students. Special learning materials will be used. Moreover, Dr Alemayehu will be in an excellent position to strongly contribute to the development of the recently established Clinical Trial Unit (CTU), and the Center for Innovative Drug Development and Therapeutic Trials for Africa (CDT-Africa) at the College of Health Sciences of the University of Addis Ababa. CDT-Africa has developed a new MSc curriculum in clinical trial research. The fellowship at Merck will also be conducive to developing international collaborations.

Regarding his personal career, Dr Alemayehu is interested in the development of better medicinal products for malaria, tuberculosis, HIV/AIDS, and human African trypanosomiasis. He will be qualified to compete for international and national research grants such as the Thematic Research Grants awarded by the University, the Ministry of Science and Technology, and the Ministry of Health (Grand Challenge Ethiopia). Using reintegration funds from EDCTP, he will also be able to purchase small research instruments or services and solicit further funding. He will lead team formation for the Infectious Disease Pharmacology Research Group and supervise several PhD and MSc graduate students. He intends also to lend his support to the growing pharmaceutical sector in Ethiopia.

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