Lack of tumors in infants with perinatal HIV-1 exposure and fetal/neonatal exposure to zidovudine

  • I. Celine Hanson
  • , Tracy A. Antonelli
  • , Rhoda S. Sperling
  • , James M. Oleske
  • , Ellen Cooper
  • , Mary Culnane
  • , Mary Glenn Fowler
  • , Leslie A. Kalish
  • , Sophia S. Lee
  • , George McSherry
  • , Lynne Mofenson
  • , David E. Shapiro

Research output: Contribution to journalArticlepeer-review

105 Scopus citations

Abstract

Zidovudine (ZDV) therapy during pregnancy and to the neonate reduced perinatal HIV transmission by nearly 70% in Pediatric AIDS Clinical Trials Group (PACTG) protocol 076. ZDV has been reported as positive in several in vitro carcinogenicity screening tests. We evaluated the short-term risk for tumors in 727 children with known ZDV exposure enrolled into the PACTG 076/219 and the Women and Infants Transmission Study (WITS). ZDV exposure in utero (antepartum) occurred in 97% and 99% of infants in PACTG 076/219 or WITS, respectively. Mean follow-up was 38.3 months with 366.9 person years follow-up for PACTG 076/219 and 14.5 months with 743.7 person years follow- up for WITS. No tumors of any nature were observed; relative risk was 0 (95% confidence interval [CI], 0-17.6). These data are reassuring regarding the short-term lack of tumors for ZDV-exposed infants observed to date. Longitudinal, standardized follow-up for infants with in utero antiretroviral exposure is necessary to assess long-term carcinogenicity.

Original languageEnglish (US)
Pages (from-to)463-467
Number of pages5
JournalJournal of Acquired Immune Deficiency Syndromes and Human Retrovirology
Volume20
Issue number5
DOIs
StatePublished - Apr 15 1999

All Science Journal Classification (ASJC) codes

  • Immunology and Allergy
  • Immunology
  • Virology

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