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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

Current guidelines for HIV management and mother-to-child-transmission prevention in Mozambique rely on lifelong administration of antiretroviral therapy (ART) (option B+) from the time of HIV diagnosis during pregnancy. Thus, HIV-infected pregnant women need to self-administer an average of five tablets from different medications daily. Available information suggests that adherence to these medications is poor and retention rate is low, while there is little understanding of the factors affecting this.

Moreover, there are no data on the proportion and clinical presentation of pregnant women with advanced HIV disease, which is needed for the implementation of new management guidelines for individuals with advanced HIV disease.

With malaria in pregnancy, HIV-infected pregnant women cannot receive intermittent preventive treatment (IPTp) with sulphadoxine-pyrimethamine for malaria prevention due to potential drug interactions with cotrimoxazole prophylaxis (CTXp), which is administered to prevent opportunistic infections.

Dr Nhampossa aims to identify the factors that influence the effectiveness of HIV control strategies in pregnant women exposed to malaria in rural southern Mozambique, in order to assist policymakers in the implementation of the appropriate interventions for this group of women most vulnerable to both infections. Specific objectives of the project are: 1) to assess perceptions, acceptability and behaviour of HIV-infected pregnant women regarding the administration of the recommended multiple medications; 2) to assess the retention rate to Option B+ and its determinants; 3) to determine the proportion, characteristics and clinical presentation of pregnant women attending the antenatal care clinic with HIV advanced disease.

In this project the fellow is using three sources of information: 1) participants in a randomised placebo-controlled trial to evaluate the safety and efficacy of dihydroartemisinin-piperaquine for IPTp in HIV-infected pregnant women receiving CTXp; 2) pregnant women attending the same antenatal care clinic who do not participate in the above-mentioned trial, 3) retrospectively collected data from HIV-infected pregnant women attending the antenatal care clinics.

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.

Importantly, the results of the research that is part of this fellowship, may help to guide public health policies contributing to the improvement of maternal and child health in the most vulnerable populations.

As regards capacity development, this fellowship will train a junior African researcher in epidemiology, qualitative research and statistical analysis. Additionally, the fellow will have the opportunity to interact with collaborators from other African and European research institutions.

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