BACKGROUND: Although zidovudine prophylaxis decreases the rate of trans mission of the human immunodeficiency virus (HIV) type 1 substantially, a large number of infants still become infected. We hypothesized that the administration, in ad dition to zidovudine, of a single dose of oral nevirapine to mothers during labo r and to neonates would further reduce transmission of HIV.METHODS: We conducted a randomized, double-blind trial of three treatment regimens in Thai women who were receiving zidovudine therapy during the third trimester of pregnancy. In o ne group, mothers and infants received a single dose of nevirapine (nevirapine- nevirapine regimen);in another, mothers and infants received nevirapineand place bo, respectively (nevirapine-placebo regimen); and in the last, mothers and inf ants received placebo (placebo-placebo regimen). The infants also received one week of zidovudine therapy and were formula-fed.The end point of the study was infection with HIV in the infants, established by virologic testing. RESULTS:Bet ween January 15, 2001, and February 28, 2003, a total of 1844 Thai women were en rolled. At the first interim analysis, the independent data monitoring committee stopped enrollment in the placebo-placebo group.Among women who delivered befo re the interim analysis,the as-randomized Kaplan-Meier estimates of the transm ission rates were 1.1 percent (95 percent confidence interval, 0.3 to 2.2) in th e nevirapine-nevirapine group and 6.3 percent (95 percent confidence interval,3 .8 to 8.9) in the placebo-placebo group (P< 0.001). The final per-protocol tra nsmission rate in the nevirapine-nevirapine group, 1.9 percent (95 percent conf idence interval,0.9 to 3.0), was not significantly inferior to the rate in the n evirapine-placebo group (2.8 percent; 95 percent confi-dence interval, 1.5 to 4.1). Nevirapine had an effect within subgroups defined by known risk factors su ch as viral load and CD4 count. No serious adverse effects were associated with nevirapine therapy. CONCLUSIONS: A single dose of nevirapine to the mother, with or without a dose of nevirapine to the infant, added to oral zidovudine prophyl axis starting at 28 weeks’gestation, is highly effective in reducing mother-to -child transmission of HIV.
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