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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 progression of HIV disease and its associated morbidity and mortality among childhood populations has decreased dramatically over the past decade as a result of an unprecedented global effort at scaling up universal access to antiretroviral therapy. In spite of these successes, many children living with HIV disease continue to die as a result of paediatric pneumonia. Although bacteria agents like Mycobacterium tuberculosis complex are often considered as the main agent involved, the role of other bacteria agents and viruses still remains unclear and difficult to determine in clinical practice.

The main objective of this project is to describe the nasopharyngeal microbiota of HIV-positive children and determine its association with respiratory diseases, specifically, the identification of specific microbiota associated with respiratory disease in HIV-positive children.

Dr Owusu’s research will be a longitudinal study for which 100 HIV-positive children with respiratory disease will be recruited alongside 100 age-matched HIV-negative controls without respiratory disease. All children will be followed up for 24 months for signs and symptoms of respiratory disease and/or pneumonia. Nasopharyngeal swabs will be taken from all subjects at enrolment and also at the various time points that subjects may present with and recover from respiratory disease. All swab samples will be tested for common respiratory viruses using multiplex real-time PCR. Bacterial agents will also be identified using conventional bacteriological techniques and PCR as well as sequencing techniques that will target the range of bacterial pathogens in the nasopharynx. Clinical data on subject’s demography, clinical presentations, antibiotic or antiviral treatment, co-morbidities, tuberculosis status and other clinical indicators of well-being will be retrieved from their folders.

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 study will contribute to child health in Ghana by generating baseline data that would determine the pathogens associated with respiratory disease in HIV-positive children.

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