title: Lack of tumors in infants with perinatal HIV-1 exposure and fetal/neonatal exposure to zidovudine.
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.
authors.affiliation: Baylor College of Medicine, Houston, Texas, USA.
authors.forename: I C
authors.initials: IC
authors.lastname: Hanson
authors.forename: T A
authors.initials: TA
authors.lastname: Antonelli
authors.forename: R S
authors.initials: RS
authors.lastname: Sperling
authors.forename: J M
authors.initials: JM
authors.lastname: Oleske
authors.forename: E
authors.initials: E
authors.lastname: Cooper
authors.forename: M
authors.initials: M
authors.lastname: Culnane
authors.forename: M G
authors.initials: MG
authors.lastname: Fowler
authors.forename: L A
authors.initials: LA
authors.lastname: Kalish
authors.forename: S S
authors.initials: SS
authors.lastname: Lee
authors.forename: G
authors.initials: G
authors.lastname: McSherry
authors.forename: L
authors.initials: L
authors.lastname: Mofenson
authors.forename: D E
authors.initials: DE
authors.lastname: Shapiro
mesh_terms: D019380:Anti-HIV Agents / Q000627:therapeutic use*; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy* / Q000503:physiopathology* / Q000635:transmission; D015497:HIV-1; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical; D008297:Male; D009369:Neoplasms / Q000517:prevention & control*; D018743:Perinatal Care; D011247:Pregnancy; D011446:Prospective Studies; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use*; D015215:Zidovudine / Q000627:therapeutic use*
chemical_list: D019380:Anti-HIV Agents; D000964:Antimetabolites, Antineoplastic; D018894:Reverse Transcriptase Inhibitors; D015215:Zidovudine