title: Laboratory Abnormalities Among HIV-Exposed, Uninfected Infants: IMPAACT Protocol P1025.
abstract: BACKGROUND
  Infant laboratory abnormalities have been associated with exposure to antiretrovirals and to trimethoprim/sulfamethoxazole (TMP/SMX).
  
  
  METHODS
  We analyzed data from International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) Protocol P1025, a prospective cohort study of human immunodeficiency virus type 1 (HIV)-infected women and their infants. Live-born, singleton, HIV-uninfected infants with at least 6 months of follow-up who represented the first pregnancy on study of HIV-infected mothers with at least 1 prenatal visit, CD4 count, and viral load during pregnancy and who used at least 1 antiretroviral during pregnancy were eligible for inclusion in this analysis.
  
  
  RESULTS
  The study population comprised 1524 infants. During the first 6 months of life, 7.4% of laboratory serious adverse events (SAEs) were related to glucose, 7.2% were related to hemoglobin, 8.7% were related to absolute neutrophil count, and 4.0% were related to total lymphocyte count. The likelihood of laboratory SAEs decreased with increasing age for hemoglobin, absolute neutrophil count, and glucose. Infant preterm birth and current receipt of antiretroviral(s) were the factors with the strongest associations with laboratory SAEs.
  
  
  CONCLUSIONS
  The overall frequency of laboratory SAEs was low and decreased with age. Preterm infants are at higher risk of hemoglobin- and total lymphocyte count-related SAEs.
authors.affiliation: Pediatric, Adolescent, and Maternal AIDS Branch, Center for Research for Mothers and Children, National Institute of Child Health and Human Development, National Institutes of Health, Department of Health and Human Services, Bethesda, Maryland.
authors.forename: Jennifer S
authors.initials: JS
authors.lastname: Read
authors.affiliation: Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts.
authors.forename: Yanling
authors.initials: Y
authors.lastname: Huo
authors.affiliation: Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts Department of Epidemiology, Harvard School of Public Health, Boston, Massachusetts.
authors.forename: Kunjal
authors.initials: K
authors.lastname: Patel
authors.affiliation: Department of Pediatrics, Jackson Memorial Hospital, Miami, Florida.
authors.forename: Marcia
authors.initials: M
authors.lastname: Mitchell
authors.affiliation: Department of Pediatrics, University of Miami Miller School of Medicine, Miami, Florida.
authors.forename: Gwendolyn B
authors.initials: GB
authors.lastname: Scott