SAFETY OF THE MATERNAL-INFANT ZIDOVUDINE REGIMEN UTILIZED IN THE PEDIATRIC AIDS CLINICAL-TRIAL GROUP-076 STUDY

Objective: To determine the safety of the zidovudine (ZDV) regimen uti lized in the Pediatric AIDS Clinical Trial Group (ACTG) 076 study. Des ign: ACTG 076 was a randomized, double-blind, placebo-controlled trial which demonstrated that a ZDV regimen could prevent mother-to-child H IV-1 transmission. Infants were followed through 18 months of age and women were followed through 6 months postpartum. Methods: Maternal com plications, pregnancy outcomes, growth and development of the uninfect ed infants, and HIV-1 disease progression in the women were monitored prospectively. Results: Maternal therapy was well tolerated. There was no serious pattern of adverse pregnancy outcomes associated with ZDV use. Amongst the ZDV-exposed infants, the only recognized toxicity was anemia within the first 6 weeks of life; the risk for anemia was not associated with premature delivery, duration of maternal treatment, de gree of maternal immunosuppression, or maternal anemia. ZDV treatment was not associated with an increased incidence of newborn structural a bnormalities. At 18 months of age, uninfected infants did not differ i n growth parameters or immune function. No childhood neoplasias were r eported in either group. In the women, at 6 months postpartum, there w ere no differences in clinical, immunologic, or virologic disease prog ression. Conclusion: There were no identified problems that would alte r current recommendations for the routine use of ZDV for the preventio n of mother-child HIV-1 transmission. (C) 1998 Lippincott Williams & W ilkins.