title: Safety of late in utero exposure to zidovudine in infants born to human immunodeficiency virus-infected mothers: Bangkok. Bangkok Collaborative Perinatal HIV Transmission Study Group.
abstract: BACKGROUND
  Short-course zidovudine (ZDV) given in the late antenatal period can reduce mother-infant human immunodeficiency virus (HIV) transmission by one half. Because this intervention is being implemented in developing countries, evidence of its safety is needed.
  
  
  METHODS
  In a randomized, double-blinded, placebo-controlled trial in Bangkok, HIV-infected pregnant women received either ZDV (300 mg twice daily from 36 weeks' gestation until labor, then every 3 hours until delivery) or an identical placebo regimen. Infants were evaluated at birth and at 1, 2, 4, 6, 9, 12, 15, and 18 months of age. Growth, clinical events, and hematologic and immunologic measurements were compared between treatment groups.
  
  
  RESULTS
  Of the 395 children born (196 in ZDV group and 199 in placebo group), 330 were uninfected, 55 were infected, and 10 had indeterminate infection status. Overall, 319 children (81%) completed 18 months of follow-up, and 14 (4%) died before 18 months of age. Among uninfected children, the mean hematocrit was lower in the ZDV group at birth (49.1% vs 51.5%) but not at later ages; mean weight, height, head circumference, and CD4(+) and CD8(+) T lymphocyte counts were similar in both groups at all ages. Five uninfected children in the ZDV group but only one in the placebo group had a febrile convulsion. No other signs suggestive of mitochondrial dysfunction and no tumors were observed. Among infected children, an estimated 62% in the ZDV group and 77% in the placebo group survived free of Centers for Disease Control and Prevention class C disease during the 18-month follow-up.
  
  
  CONCLUSIONS
  No significant adverse events were associated with short-course ZDV during 18 months of follow-up in this population.
authors.affiliation: Queen Sirikit National Institute for Child Health, Department of Medical Services, Ministry of Public Health, Bangkok, Thailand.
authors.forename: T
authors.initials: T
authors.lastname: Chotpitayasunondh
authors.forename: N
authors.initials: N
authors.lastname: Vanprapar
authors.forename: R J
authors.initials: RJ
authors.lastname: Simonds
authors.forename: K
authors.initials: K
authors.lastname: Chokephaibulkit
authors.forename: N
authors.initials: N
authors.lastname: Waranawat
authors.forename: P
authors.initials: P
authors.lastname: Mock
authors.forename: M A
authors.initials: MA
authors.lastname: Stat
authors.forename: R
authors.initials: R
authors.lastname: Chuachoowong
authors.forename: N
authors.initials: N
authors.lastname: Young
authors.forename: T D
authors.initials: TD
authors.lastname: Mastro
authors.forename: N
authors.initials: N
authors.lastname: Shaffer
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy* / Q000401:mortality / Q000635:transmission*; D000328:Adult; D018791:CD4 Lymphocyte Count; D018414:CD8-Positive T-Lymphocytes / Q000187:drug effects; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006128:Growth; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control* / Q000706:statistics & numerical data; D008297:Male; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D019562:Viral Load; D015215:Zidovudine / Q000008:administration & dosage*
chemical_list: D015215:Zidovudine