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 B Scott, Mary Jo O'Sullivan, Russell Vandyke, Mohammed Bey, William Shearer, Robert L. Jacobson, Eleanor Jimenez, Edward O'Neill, Brigitte Bazin, Jean François Delfraissy, Mary Culnane, Robert Coombs, Mary Elkins, Jack Moye, Pamela Stratton, James Balsley

Research output: Contribution to journalArticle

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Abstract

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. Conclusions. In pregnant women with mildly symptomatic HIV disease and no prior treatment with antiretroviral drugs during the pregnancy, a regimen consisting of zidovudine given ante partum and intra partum to the mother and to the newborn for six weeks reduced the risk of maternal-infant HIV transmission by approximately two thirds.

Original languageEnglish
Pages (from-to)1173-1180
Number of pages8
JournalNew England Journal of Medicine
Volume331
Issue number18
DOIs
StatePublished - Nov 3 1994

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Zidovudine
HIV-1
Mothers
Placebos
Therapeutics
Pregnant Women
Parturition
Virus Diseases
Confidence Intervals
Pregnancy
Hemoglobins
Newborn Infant
Poisons
Risk Reduction Behavior
CD4 Lymphocyte Count
Blood Cells
Body Weight
T-Lymphocytes
Safety

ASJC Scopus subject areas

  • Medicine(all)

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Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. / Connor, Edward M.; Sperling, Rhoda S.; Gelber, Richard; Kiselev, Pavel; Scott, Gwendolyn B; O'Sullivan, Mary Jo; Vandyke, Russell; Bey, Mohammed; Shearer, William; Jacobson, Robert L.; Jimenez, Eleanor; O'Neill, Edward; Bazin, Brigitte; Delfraissy, Jean François; Culnane, Mary; Coombs, Robert; Elkins, Mary; Moye, Jack; Stratton, Pamela; Balsley, James.

In: New England Journal of Medicine, Vol. 331, No. 18, 03.11.1994, p. 1173-1180.

Research output: Contribution to journalArticle

Connor, EM, Sperling, RS, Gelber, R, Kiselev, P, Scott, GB, O'Sullivan, MJ, Vandyke, R, Bey, M, Shearer, W, Jacobson, RL, Jimenez, E, O'Neill, E, Bazin, B, Delfraissy, JF, Culnane, M, Coombs, R, Elkins, M, Moye, J, Stratton, P & Balsley, J 1994, 'Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment', New England Journal of Medicine, vol. 331, no. 18, pp. 1173-1180. https://doi.org/10.1056/NEJM199411033311801
Connor, Edward M. ; Sperling, Rhoda S. ; Gelber, Richard ; Kiselev, Pavel ; Scott, Gwendolyn B ; O'Sullivan, Mary Jo ; Vandyke, Russell ; Bey, Mohammed ; Shearer, William ; Jacobson, Robert L. ; Jimenez, Eleanor ; O'Neill, Edward ; Bazin, Brigitte ; Delfraissy, Jean François ; Culnane, Mary ; Coombs, Robert ; Elkins, Mary ; Moye, Jack ; Stratton, Pamela ; Balsley, James. / Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. In: New England Journal of Medicine. 1994 ; Vol. 331, No. 18. pp. 1173-1180.
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abstract = "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. Conclusions. In pregnant women with mildly symptomatic HIV disease and no prior treatment with antiretroviral drugs during the pregnancy, a regimen consisting of zidovudine given ante partum and intra partum to the mother and to the newborn for six weeks reduced the risk of maternal-infant HIV transmission by approximately two thirds.",
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T1 - Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment

AU - Connor, Edward M.

AU - Sperling, Rhoda S.

AU - Gelber, Richard

AU - Kiselev, Pavel

AU - Scott, Gwendolyn B

AU - O'Sullivan, Mary Jo

AU - Vandyke, Russell

AU - Bey, Mohammed

AU - Shearer, William

AU - Jacobson, Robert L.

AU - Jimenez, Eleanor

AU - O'Neill, Edward

AU - Bazin, Brigitte

AU - Delfraissy, Jean François

AU - Culnane, Mary

AU - Coombs, Robert

AU - Elkins, Mary

AU - Moye, Jack

AU - Stratton, Pamela

AU - Balsley, James

PY - 1994/11/3

Y1 - 1994/11/3

N2 - 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. Conclusions. In pregnant women with mildly symptomatic HIV disease and no prior treatment with antiretroviral drugs during the pregnancy, a regimen consisting of zidovudine given ante partum and intra partum to the mother and to the newborn for six weeks reduced the risk of maternal-infant HIV transmission by approximately two thirds.

AB - 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. Conclusions. In pregnant women with mildly symptomatic HIV disease and no prior treatment with antiretroviral drugs during the pregnancy, a regimen consisting of zidovudine given ante partum and intra partum to the mother and to the newborn for six weeks reduced the risk of maternal-infant HIV transmission by approximately two thirds.

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