Infant diagnoses in A Phase IV Randomized Trial to Evaluate the Virologic Response and Pharmacokinetics of Two Different Triple Antiretroviral Regimens in HIV Infected Women Initiated Between 28 and 36 Weeks of Pregnancy for the Prevention of Mother-to-Child Transmission

Infant diagnoses dataset
Study Description
P1081 was a Phase IV multicenter, randomized, open-label trial comparing the virologic response, safety, and tolerability of raltegravir. The study population included Human Immunodeficiency Virus (HIV)-1 infected pregnant women with a gestational age between 28 and 36 weeks who are antiretroviral (ARV) naïve or have received short-course zidovudine only for prevention of mother-to-child transmission in previous pregnancies, and their infants. The primary objectives were to compare the ability of two triple ARV regimens (one containing efavirenz and the other raltegravir) begun during the third trimester of pregnancy to achieve a viral load of < 200 copies/mL at the time of delivery and compare the safety and tolerability of two triple ARV regimens (one containing efavirenz and the other raltegravir) begun during the third trimester of pregnancy. All women received a randomized regimen from study entry through delivery. The study showed both regimens to be safe and well-tolerated. The rate of suppression at delivery was found to be higher with raltegravir, primarily with those enrolling in the third trimester. Pregnancy outcomes in this study were consistent with previous studies of initiation of other antiretroviral regimens in pregnancy. While the HIV perinatal transmission rate was not significantly different between treatment arms in our study, substantially fewer infants were infected in the raltegravir arm compared to the efavirenz arm. The results of this study support the use of raltegravir in pregnant women who present late for care. HIV-infected pregnant women with a gestational age between 28 and 36 weeks were randomly assigned to one of two arms

婴儿诊断数据集
研究概况
P1081为一项IV期多中心随机开放标签试验，旨在比较雷特格韦（raltegravir）的病毒学应答、安全性与耐受性。本研究的研究人群包括孕周介于28至36周的人类免疫缺陷病毒（Human Immunodeficiency Virus, HIV）-1感染妊娠妇女，这些妇女要么为抗反转录病毒（antiretroviral, ARV）初治者，要么仅在既往妊娠中接受过短疗程齐多夫定（zidovudine）以预防母婴传播，同时纳入其分娩的婴儿。本研究的主要目的为比较两种三联抗反转录病毒治疗方案（一种含依非韦伦（efavirenz），另一种含雷特格韦）于妊娠第三阶段启动给药后，在分娩时实现病毒载量低于200拷贝/毫升（copies/mL）的能力，并比较这两种方案于妊娠第三阶段启动给药后的安全性与耐受性。所有受试者自研究入组至分娩期间均接受随机分配的治疗方案。研究结果显示，两种方案均安全且耐受性良好。研究发现，接受雷特格韦方案的受试者在分娩时的病毒抑制率更高，尤其是在妊娠第三阶段入组的受试者。本研究中的妊娠结局与既往其他抗反转录病毒治疗方案在妊娠中应用的研究结果一致。尽管本研究中各治疗组的HIV围产期传播率无显著差异，但与依非韦伦组相比，雷特格韦组的感染婴儿数量显著更少。本研究结果支持为就诊较晚的妊娠妇女使用雷特格韦。孕周介于28至36周的HIV感染妊娠妇女被随机分配至两个治疗组之一。