HPTN 040/P1043 Lamivudine (3TC)Treatment Record Dataset in Phase III Randomized Trial of the Safety and Efficacy of Three Neonatal Antiretroviral Regimens For Prevention Of Intrapartum HIV-1 Transmission

Dose and status of 3TC treatment and reason for discontinuation, as appropriate (Treatment Record 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

拉米夫定（3TC）治疗的剂量、治疗状态，以及适宜情况下的停药原因（治疗记录病例报告表（Treatment Record CRF））。研究描述：本研究对比了三种抗反转录病毒治疗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（ZDV）联合奈韦拉平（Nevirapine, NVP）方案，以及齐多夫定（ZDV）、拉米夫定（Lamivudine, 3TC）联合奈非那韦（Nelfinavir, NFV）方案。上述方案用于预防本次妊娠期间未接受抗反转录病毒治疗的HIV-1感染女性所生婴儿的HIV-1母婴垂直传播。本研究的主要结局指标为出生时未感染HIV-1的婴儿在出生后3个月时的HIV-1感染状况。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）下属的HIV预防试验网络（HIV Prevention Trials Network, HPTN）开展。研究可提供生物样本。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-1感染女性，及其1745名新生儿；下文的种族与民族数据仅针对受试母亲。