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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

Malaria in pregnancy is an issue of public health concern due to the risk of significant adverse maternal and infant outcomes. Nigeria currently has the highest infection and transmission rates, as well as the highest at-risk population for malaria disease globally.

Intermittent preventive treatment in pregnancy (IPTp) is strongly advocated to reduce the occurrence of this disease, but resistance to the currently prescribed drug i.e. sulphadoxine-pyrimethamine (SP) is already being reported. However, data on the occurrence of IPTp-SP resistance in Nigeria and West Africa is scarce.

This project aims to describe the burden of sulphadoxine-pyrimethamine (SP) resistance and determinants of its occurrence among pregnant women receiving Intermittent Preventive Treatment (IPTp) in Nigeria. It will also identify connections between SP drug resistance markers and efficacy of IPTp-SP, as well as assess maternal and neonatal health outcomes.

A prospective observational study will be conducted for 24 months within a malaria-endemic community. Pregnant women will be counselled during their antenatal clinic visits and consenting women meeting the inclusion criteria will be recruited for the study. Relevant socio-demographic and obstetric information will be obtained, and blood samples will be taken pre- and post-IPTp-SP administration at scheduled intervals, for analysis. Microscopically confirmed parasitaemic samples will be analysed using PCR to detect drug resistance markers (pfdhfr and pfdhps). Participants will be followed up until 7 days post-delivery and assessed for maternal and fetal outcomes (anaemia, low birth weight, preterm delivery, placental parasitaemia, stillbirth, early neonatal death).

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.

As data on the occurrence of IPTp-SP resistance in Nigeria and West Africa is scarce, this study will contribute to filling this gap in the relevant body of knowledge. The study is the first in this region of Nigeria and will generate data to complete the picture of sulphadoxine-pyrimethamine resistance. The data may form a reference and benchmark for other studies replicated in other regions to produce a national overview of sulphadoxine-pyrimethamine resistance. This will also help government public health officials to review current practices pertaining to intermittent malaria chemoprophylaxis in pregnancy. Moreover, the project will improve local clinical research capacity providing other researchers and scientists with data and equipment for genotypic detection of resistance traits in South-West Nigeria.

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