HPTN 040/P1043 Infant Immunizations Dataset in Phase III Randomized Trial of the Safety and Efficacy of Three Neonatal Antiretroviral Regimens For Prevention Of Intrapartum HIV-1 Transmission

Infant immunization data (Infant Non-study Medications CRF)
Study Description
Compared the efficacy and safety of three antiretroviral regimens [standard zidovudine (ZDV) regimen vs. ZDV and nevirapine (NVP) vs. ZDV, lamivudine (3TC) and nelfinavir (NFV)] administered for the prevention of vertical HIV-1 transmission to infants born to HIV-1-infected women who did not receive antiretroviral therapy during the current pregnancy. Primary outcome measure was HIV-1 infection at 3 months in infants uninfected at birth. This study was conducted by the National Institute of Allergy and Infectious Diseases (NIAID) HIV Prevention Trials Network (HPTN). Biospecimens are available. HIV positive women (n=1724) in Argentina, Brazil, South Africa, and the U.S. who did not receive antiretroviral therapy during pregnancy and their newborn infants (n=1745); race and ethnicity data below are for mothers only

婴儿免疫数据（婴儿非研究药物病例报告表（CRF））
研究概况：本研究对比了三种抗反转录病毒治疗方案的有效性与安全性，分别为标准齐多夫定（zidovudine, ZDV）方案、齐多夫定联合奈韦拉平（nevirapine, NVP）方案，以及齐多夫定、拉米夫定（lamivudine, 3TC）联合奈非那韦（nelfinavir, NFV）方案，旨在预防当前妊娠期间未接受抗反转录病毒治疗的HIV-1感染产妇所娩婴儿发生垂直HIV-1传播。主要结局指标为出生时未感染HIV-1的婴儿在3月龄时的HIV-1感染情况。本研究由美国国家过敏和传染病研究所（National Institute of Allergy and Infectious Diseases, NIAID）HIV预防试验网络（HIV Prevention Trials Network, HPTN）开展。可获取生物样本。本研究纳入阿根廷、巴西、南非及美国的1724名妊娠期间未接受抗反转录病毒治疗的HIV阳性产妇，及其1745名新生婴儿；下文的种族与族裔数据仅针对产妇。