title: Research into a functional cure for HIV in neonates: the need for ethical foresight.
abstract: In 2013, researchers announced that a newborn child from Mississippi, USA might have been functionally cured of HIV by being given combination antiretroviral therapy within hours of birth. Public and media attention has since been captured by the possibility of finding a cure for HIV transmitted from mother to child. Research into the strategy used for the Mississippi patient is crucially important to establish whether it can be replicated and shown to work in diverse populations. At the same time, any ethical issues likely to arise in such studies should be addressed and not ignored in the pursuit of a functional cure. In this Personal View we identify ethical issues that could arise in research towards achievment of a functional cure for HIV in neonates, including difficult trade-offs associated with choosing the study population and questions about the broader social implications of the research, and propose ways to resolve them.
authors.affiliation: Clinical Center Department of Bioethics, National Institutes of Health, Bethesda, MD, USA. Electronic address: shahse@mail.nih.gov.
authors.forename: Seema K
authors.initials: SK
authors.lastname: Shah
authors.affiliation: Johns Hopkins University School of Medicine and Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, MD, USA.
authors.forename: Deborah
authors.initials: D
authors.lastname: Persaud
authors.affiliation: Clinical Center Department of Bioethics, National Institutes of Health, Bethesda, MD, USA.
authors.forename: David S
authors.initials: DS
authors.lastname: Wendler
authors.affiliation: Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health and Johns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA.
authors.forename: Holly A
authors.initials: HA
authors.lastname: Taylor
authors.affiliation: Department of Pediatrics, University of Mississippi Medical Center, Jackson, MS, USA.
authors.forename: Hannah
authors.initials: H
authors.lastname: Gay
authors.affiliation: Department of Paediatrics and Child Health, Stellenbosch University, Cape Town, South Africa.
authors.forename: Mariana
authors.initials: M
authors.lastname: Kruger
authors.affiliation: Clinical Center Department of Bioethics, National Institutes of Health, Bethesda, MD, USA.
authors.forename: Christine
authors.initials: C
authors.lastname: Grady
mesh_terms: D035843:Biomedical Research / Q000941:ethics; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical