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Leidner, Jean

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Leidner, Jean

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Author's Publications: search.filters.isAuthorOfPublication.859d8dd8-d31d-479b-9f27-c297d1f04b12

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    Antiretroviral Regimens in Pregnancy and Breast-Feeding in Botswana
    (New England Journal of Medicine (NEJM/MMS), 2010) Shapiro, R.L.; Hughes, M.D.; Ogwu, Anthony; Kitch, Doug; Lockman, Shahin; Moffat, C.; Makhema, Joseph; Moyo, Sikhulile; Thior, Ibou; McIntosh, Kenneth; van Widenfelt, E.; Leidner, Jean; Powis, Kathleen; Asmelash, A.; Tumbare, E.; Zwerski, S.; Sharma, Upasna; Handelsman, E.; Mburu, K.; Jayeoba, O.; Moko, E.; Souda, Shashidhar Vaman; Lubega, E.; Akhtar, M.; Wester, C; Tuomola, R.; Snowden, W.; Martinez-Tristani, M.; Mazhani, L.; Essex, Myron
    BACKGROUND: The most effective highly active antiretroviral therapy (HAART) to prevent mother-to-child transmission of human immunodeficiency virus type 1 (HIV-1) in pregnancy and its efficacy during breast-feeding are unknown. METHODS: We randomly assigned 560 HIV-1-infected pregnant women (CD4+ count, > or = 200 cells per cubic millimeter) to receive coformulated abacavir, zidovudine, and lamivudine (the nucleoside reverse-transcriptase inhibitor [NRTI] group) or lopinavir-ritonavir plus zidovudine-lamivudine (the protease-inhibitor group) from 26 to 34 weeks' gestation through planned weaning by 6 months post partum. A total of 170 women with CD4+ counts of less than 200 cells per cubic millimeter received nevirapine plus zidovudine-lamivudine (the observational group). Infants received single-dose nevirapine and 4 weeks of zidovudine. RESULTS: The rate of virologic suppression to less than 400 copies per milliliter was high and did not differ significantly among the three groups at delivery (96% in the NRTI group, 93% in the protease-inhibitor group, and 94% in the observational group) or throughout the breast-feeding period (92% in the NRTI group, 93% in the protease-inhibitor group, and 95% in the observational group). By 6 months of age, 8 of 709 live-born infants (1.1%) were infected (95% confidence interval [CI], 0.5 to 2.2): 6 were infected in utero (4 in the NRTI group, 1 in the protease-inhibitor group, and 1 in the observational group), and 2 were infected during the breast-feeding period (in the NRTI group). Treatment-limiting adverse events occurred in 2% of women in the NRTI group, 2% of women in the protease-inhibitor group, and 11% of women in the observational group. CONCLUSIONS: All regimens of HAART from pregnancy through 6 months post partum resulted in high rates of virologic suppression, with an overall rate of mother-to-child transmission of 1.1%.