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These recommendations update the interim guidelines (1) developed by the U.S. Public Health Service for the use of zidovudine (ZDV) to reduce the risk for perinatal transmission of human immunodeficiency virus (HIV) infection. The recently reported results of AIDS Clinical Trials Group Protocol 076 demonstrated that ZDV administered to a selected group of HIV-infected pregnant women and their infants can reduce the risk for perinatal HIV transmission by approximately two-thirds. The regimen used in this trial included antenatal oral administration of ZDV beginning at 14-34 weeks of gestation and continuing throughout pregnancy, followed by intrapartum intravenous ZDV and postnatal oral administration of ZDV to the infant for 6 weeks after delivery. This document summarizes the results of the trial, discusses limitations in the interpretation of the results, reviews the potential long-term adverse effects of this ZDV regimen for infants and women, and provides recommendations for the use of ZDV to reduce perinatal transmission and for medical monitoring of pregnant women and infants receiving this therapy. Because the clinical status of many HIV-infected women may differ from that of the women in this trial, the recommendations should be tailored to each woman's clinical situation. The potential benefits, unknown long-term effects, and gaps in knowledge about her specific clinical situation must be discussed with the woman. This information is intended to provide a basis for discussion between the woman and her healthcare provider so that the woman can weigh the risks and benefits of such therapy and make informed decisions about her treatment.

Guidelines and Recommendations

United States