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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

Buruli ulcer is a neglected infectious disease caused by Mycobacterium ulcerans. It is mainly found in rural regions of West Africa, and is characterised by large, unsightly ulcers leading to extensive scarring.

Buruli ulcer can be treated effectively with a combination of antibiotics, but treatment lasts eight weeks and response rates vary markedly between patients.

Professor Richard Phillips has established an extensive programme of research on Buruli ulcer in Ghana, in partnership with collaborators in Europe. His research has provided significant input into WHO-recommended treatments for Buruli ulcer. 

During his EDCTP Senior Fellowship, Professor Phillips is testing a possible way to shorten treatment times for Buruli ulcer. There is some evidence from laboratory and clinical studies that nitric oxide is toxic to M. ulcerans. To generate further evidence, Professor Phillips is running a clinical trial that will evaluate use of a dressing designed to release nitric oxide as an addition to standard treatment (oral rifampicin and clarithromycin).

Embedded within the study will be a programme of activities to develop expertise in specialised diagnostics and laboratory techniques, as well as generic research skills such as research methodologies, statistics, research governance and administration. 

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.

Professor Phillips’s Senior Fellowship will generate important data on a potential way to shorten treatment of a neglected infectious disease that is extremely common in Ghana and neighbouring countries. By training three PhD and two master’s students, it will also build local capacity to undertake clinical studies, including controlled trials, on Buruli ulcer or other locally important infectious diseases.

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