Human Immunodeficiency Virus (HIV) infection remains a major threat to the lives of many children in Sub- Saharan Africa. Despite the great strides towards the reduction of HIV associated mortality in children, prioritizing their quality of life including neurocognitive function, is imperative.
The EMPIRICAL study is a randomized, factorial open label clinical trial investigating survival of HIV positive children under 1 year of age with pneumonia, randomizing children to receive empirical treatment for either CMV pneumonia, or TB, or both in addition to standard of care treatment for pneumonia or to only standard of care treatment (control).
Following the Sustainable Development Goals (SDGs) which call for extending the focus of child health initiatives beyond reducing mortality to reducing morbidity and improving quality of life, the Neuro-Empirical study, nested within the EMPIRICAL study aims to investigate differences in neurocognitive outcomes among children randomized to intervention versus control. The study is investigating the possibility of a neurocognitive advantage of empirical treatment of CMV and TB over standard of care treatment at discharge (baseline), one year post randomization and at two years of age. The control arms will include HIV uninfected children hospitalized with severe pneumonia and HIV infected children without pneumonia.
THE NEURO-EMPIRICAL STUDY IS FUNDED BY EDCTP (TMA2020CDF3198)