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

Data related to non-study HIV diagnostic testing, including test type, timing, and results
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

本数据集涉及非研究性HIV诊断检测相关数据，涵盖检测类型、检测时机与检测结果。
研究描述：本研究对比了三种抗逆转录病毒方案的疗效与安全性，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）与奈非那韦（nelfinavir, NFV）联合方案，旨在预防本次妊娠期间未接受抗逆转录病毒治疗的HIV-1感染孕妇所分娩婴儿的垂直HIV-1传播。本研究的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，可提供生物样本。研究对象为阿根廷、巴西、南非及美国的1724名妊娠期间未接受抗逆转录病毒治疗的HIV阳性孕妇及其1745名新生婴儿；以下种族与民族数据仅针对孕妇。