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Reassuring Findings About Infants Exposed To Zidovudine

Children exposed to zidovudine (ZDV, AZT) in utero and as newborns and who escaped acquiring HIV from their infected mothers show no cancers or other adverse health effects up through preschool age, according to a new study from the National Institutes of Health (NIH). It is the first report to assess the late effects of AZT exposure in healthy HIV-uninfected children born to mothers who took the drug to prevent transmitting HIV to their offspring.

The study, sponsored by the Pediatric AIDS Clinical Trials Group (PACTG) and funded by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Child Health and Human Development (NICHD), appears in the Jan. 13 issue of the Journal of the American Medical Association.

"These data are critically important because the current recommendation is to treat HIV-infected pregnant women with regimens that include AZT to prevent perinatal HIV transmission," says NIAID Director Anthony S. Fauci, M.D. "Although these findings are reassuring," he adds, "we need to continue to monitor these children for long-term adverse effects of the drug." The investigators plan to follow these children until at least age 21.

The 234 HIV-uninfected children evaluated in this report are part of PACTG 219, a long-term follow-up study that includes more than 2,200 children who have been enrolled in PACTG prevention and treatment protocols. The 234 children were born to mothers who participated in PACTG 076. This landmark NIH study showed that AZT can reduce HIV transmission from an infected woman to her infant by approximately two-thirds. The children in PACTG 076 were exposed to AZT or a placebo in utero and during labor and delivery, and also as newborns for six weeks.

The randomized design of PACTG 076 and subsequent follow-up in this study makes it easier to clearly evaluate AZT's potential toxicity, the investigators note. The health of children who received AZT (122 children) can
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Contact: Laurie K. Doepel
ldoepel@nih.gov
301-402-1663
NIH/National Institute of Allergy and Infectious Diseases
12-Jan-1999


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