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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

This fellowship aimed to support the fellow to acquire skills in clinical research and development through placement at the Novartis Institutes for Biomedical Research (NIBR).

To improve his theoretical and practical capabilities in clinical trials, Dr Abay completed advanced training organised by NIBR. The assigned courses included advanced GCP, clinical trial monitoring, pharmacokinetic analysis, data management, clinical trials project management, and working practices and SOPs.

Dr Abay was also engaged in phase I and phase II clinical trials. The work included reviewing clinical trials protocols and preparation of clinical study reports. He also conducted remote monitoring and site co-monitoring of company-sponsored studies.

During the reintegration phase of the fellowship at Addis Ababa University, a clinical research protocol template was developed to support researchers in developing protocols with the appropriate content and correct format for submission to the institutional review board and the regulatory authority. Similarly, he supported faculties at the University of Addis Ababa in their efforts to strengthen the phase I clinical trial centre and its side laboratory. He also organised a two-day national training workshop on medicine development and regulation. At the same time, Dr Abay was assigned to be a member and the secretary of the institutional review board of the College of Health Sciences at the Addis Ababa University.

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.

At Novartis, Dr Abay broadened his knowledge of clinical trial operations, ethics review processes and regulatory authority functions. In his home institution at Addis Ababa University, he shared his clinical research skills by training postgraduate students and collaborated with the university and other national institutions to improve clinical research management. As a member and secretary of the institutional review board, he reviews clinical research protocols and is involved in the follow-up of clinical studies. Furthermore, Dr Abay contributed to reviewing curricula of postgraduate programs involving clinical research which will be hosted at the Center for Innovative Drug Development & Therapeutic Trials for Africa (CDT-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