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Adobe Flash Player is required to view this feature. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Original Article Reduction of Maternal-Infant Transmission of Human Immunodeficiency Virus Type 1 with Zidovudine Treatment Edward M. Connor, Rhoda S. Sperling, Richard Gelber, Pavel Kiselev, Gwendolyn Scott, Mary Jo O'Sullivan, Russell VanDyke, Mohammed Bey, William Shearer, Robert L. Jacobson, Eleanor Jimenez, Edward O'Neill, Brigitte Bazin, Jean-Francois Delfraissy, Mary Culnane, Robert Coombs, Mary Elkins, Jack Moye, Pamela Stratton, and James Balsley, for the Pediatric AIDS Clinical Trials Group Protocol 076 Study Group N Engl J Med 1994; 331:1173-1180 DOI: 10.1056/NEJM11801.

Dlc9g Platform Cable Usb Driver. Background and Methods Maternal-infant transmission is the primary means by which young children become infected with human immunodeficiency virus type 1 (HIV). We conducted a randomized, double-blind, placebo-controlled trial of the efficacy and safety of zidovudine in reducing the risk of maternal-infant HIV transmission.

HIV-infected pregnant women (14 to 34 weeks' gestation) with CD4+ T-lymphocyte counts above 200 cells per cubic millimeter who had not received antiretroviral therapy during the current pregnancy were enrolled. The zidovudine regimen included antepartum zidovudine (100 mg orally five times daily), intrapartum zidovudine (2 mg per kilogram of body weight given intravenously over a one-hour period, then 1 mg per kilogram per hour until delivery), and zidovudine for the newborn (2 mg per kilogram orally every six hours for six weeks).

Infants with at least one positive HIV culture of peripheral-blood mononuclear cells were classified as HIV-infected. Results From April 1991 through December 20, 1993, the cutoff date for the first interim analysis of efficacy, 477 pregnant women were enrolled; during the study period, 409 gave birth to 415 live-born infants.

HIV-infection status was known for 363 births (180 in the zidovudine group and 183 in the placebo group). Thirteen infants in the zidovudine group and 40 in the placebo group were HIV-infected. The proportions infected at 18 months, as estimated by the Kaplan-Meier method, were 8.3 percent (95 percent confidence interval, 3.9 to 12.8 percent) in the zidovudine group and 25.5 percent (95 percent confidence interval, 18.4 to 32.5 percent) in the placebo group. This corresponds to a 67.5 percent (95 percent confidence interval, 40.7 to 82.1 percent) relative reduction in the risk of HIV transmission (Z = 4.03, P = 0.00006). Minimal short-term toxic effects were observed. The level of hemoglobin at birth in the infants in the zidovudine group was significantly lower than that in the infants in the placebo group.

By 12 weeks of age, hemoglobin values in the two groups were similar. Maternal-infant transmission is the primary means by which young children become infected with human immunodeficiency virus type 1 (HIV). From 15 to 40 percent of infants born to infected mothers become infected in utero, during labor and delivery, or by breast-feeding. Current evidence suggests that most maternal-infant HIV transmission occurs late in pregnancy or during labor and delivery. Despite treatment, pediatric HIV infection remains a fatal disease whose prevention is of paramount importance.

Animal models of retroviral infection demonstrate that zidovudine may prevent or alter the course of maternally transmitted HIV infection. Phase 1 studies in pregnant women suggested that this medication is safe when used for short periods and that it crosses the placenta well.

To assess the safety and efficacy of zidovudine for the prevention of maternal-infant HIV transmission, the Pediatric AIDS Clinical Trials Group conducted a multicenter clinical trial (Protocol 076) in the United States and France. At the first interim analysis of efficacy, the Data and Safety Monitoring Board recommended that the enrollment of additional patients be discontinued and that all patients receiving a study drug in blinded fashion be offered zidovudine treatment. This recommendation was based on the demonstration of efficacy of zidovudine in reducing the risk of maternal-infant transmission of HIV. We report the results of this trial through December 20, 1993, the date of the data cutoff in the first interim efficacy analysis. Trial Design Our double-blind, placebo-controlled, randomized study enrolled pregnant, HIV-infected women between 14 and 34 weeks' gestation whose CD4+ T-lymphocyte counts were above 200 cells per cubic millimeter and who had no indication for antiretroviral therapy in the judgment of their health care providers. All the women had to meet the following laboratory criteria: hemoglobin concentration, ≥ 8 g per deciliter; absolute neutrophil count, ≥ 1000 cells per cubic millimeter; platelet count, ≥ 100,000 cells per cubic millimeter; serum alanine aminotransferase concentration, ≤ 2.5 times the upper limit of normal; and serum creatinine concentration, ≤ 1.5 mg per deciliter (130 μmol per liter), or eight-hour urinary creatinine clearance, >70 ml per minute.