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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

The Malaria Research and Training Centre (MRTC) in Bamako, Mali, has developed an integrated approach to the study of malaria using clinical and molecular biology as a basis of addressing field epidemiological and entomological problems at the community level. The MRTC has conducted numerous, longitudinal cohort studies, case-control studies, drug efficacy trials and malaria vaccine trials. However, the centre has little experience in early-stage drug discovery and diagnostic tools development. Consequently, there are very few well-trained researchers in these areas.

To strengthen the capacity of MRTC, Dr Nouhoum Diallo will acquire experience working on malaria clinical development projects during a placement at Novartis Pharma AG - Global Drug Development in Basel, Switzerland.

The work plan for the placement comprises 1) acquiring advanced laboratory skills, 2) gain hands-on knowledge of and insight in drug discovery and the path of diagnostic test development, and 3) all aspects of clinical trials.

The programme will focus on scientific concepts and (malaria) research design (clinical trial design, statistics, clinical pharmacology and protocol development); 2) ethical considerations and patient safety; 3) drug development and regulation (clinical development pipeline and regulatory pathway to medicines approval); 4) clinical trials operations and study implementation ( obtaining ethical and regulatory approval, study participant recruitment, adverse event identification and reporting, post-marketing surveillance and pharmacovigilance, quality control and clinical trial monitoring, including adherence and maintaining trial master and investigator files); 5) data management and informatics; 6) clinical trial reporting; 7) networking with clinical trial stakeholders.

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.

In the second phase of his fellowship, Dr Diallo will transfer the knowledge and experience he acquired through workshops, seminars, round table conferences and by teaching peers, colleagues and students. In collaboration with senior researchers, a multi-module comprehensive workshop on clinical trial research will be held at the MRTC. Generally, the placement will contribute to the expansion of the research scope at MRTC in Mali.

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