Recommendations of the U.S. Public Health Service Task Force on the Use of Zidovudine to Reduce Perinatal Transmission of Human Immuno deficiency Virus

MMWR

August 5, 1994

from breastfeeding will not prevent transmission occurring in utero or intrapartum,
and strategies to reduce transmission during these periods are being evaluated.
The recently reported interim results of the Acquired Immunodeficiency Syndrome
(AIDS) Clinical Trials Group (ACTG) Protocol 076, a clinical trial sponsored by the
National Institutes of Health in collaboration with the National Institute of Health and
Medical Research and the National Agency of Research on AIDS in France, indicate
that zidovudine (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 (1,6). This use of ZDV has the potential to substantially reduce the
rate of perinatal transmission, which would reduce overall child mortality. However,
the results of this study are directly applicable only to HIV-infected women with characteristics similar to those of the women who entered the study, and the long-term
risks of ZDV used in this manner are not known.
On June 6-7, 1994, the U.S. Public Health Service convened a workshop, "Use of
ZDV to Prevent Perinatal HIV Transmission (ACTG Protocol 076): Workshop on Implications for Treatment, Counseling, and HIV Testing." The medical, scientific, public
health, and legal communities and interested professional, community, and advocacy
organizations were represented. The workshop addressed two issues related to the
results of ACTG Protocol 076: a) treatment recommendations for the use of ZDV to
reduce perinatal transmission of HIV and b) the implications of the trial results for HIV
counseling and testing.
This report summarizes the conclusions of the workshop with regard to the use of
ZDV to reduce perinatal transmission, provides recommendations for treatment options for HIV-infected pregnant women and their newborns and medical monitoring
for pregnant women and neonates receiving ZDV, and discusses issues related to
long-term follow-up of women and their children who have received ZDV.
BACKGROUND
Summary of Results of ACTG Protocol 076
On February 21, 1994, the National Institute of Allergy and Infectious Diseases
(NIAID) and the National Institute of Child Health and Human Development
announced the interim results of a randomized, multicenter, double-blind, placebocontrolled clinical trial, ACTG Protocol 076. Eligible participants were HIV-infected
pregnant women at 14-34 weeks of gestation who had received no antiretroviral therapy during their current pregnancy, had no clinical indications for antepartum
antiretroviral therapy, and had CD4+ T-lymphocyte counts 200/gL at the time of entry
into the study (Box 1). The study began in April 1991; as of December 20, 1993, the
time of the interim analysis, 477 women had been enrolled and 421 infants born. The
racial/ethnic distribution of the HIV-infected women enrolled in the trial was similar to
that of the total population of HIV-infected women in the United States.
Enrolled women were assigned randomly to receive a regimen of either ZDV or
placebo. The ZDV regimen included oral ZDV initiated at 14-34 weeks of gestation and
continued throughout the pregnancy, followed by intravenous ZDV during labor and
oral administration of ZDV to the infant for 6 weeks after delivery (Box 2). The placebo
regimen was administered identically. Blood specimens were obtained for HIV culture