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

102 Scopus citations


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
Issue number5
StatePublished - Apr 15 1999

All Science Journal Classification (ASJC) codes

  • Immunology and Allergy
  • Immunology
  • Virology


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