PHASE III RANDOMIZED BLINDED STUDY OF NEVIRAPINE VS NEVIRAPINE PLACEBO

奈韦拉平与奈韦拉平安慰剂的 III 期随机盲研究

• 批准号: 6265630
• 负责人: SANDRA BURCHETT
• 金额: $ 0.07万
• 依托单位: BOSTON CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6265630
• 关键词: AIDS therapy; HIV infections; antiAIDS agent; clinical research; female; human immunodeficiency virus 1; human milk; human pregnant subject; human therapy evaluation; nevirapine; newborn human (0-6 weeks); oral administration; perinatal; pharmacokinetics; uterus; vagina; vertical transmission; virion; women's health

Phase III, randomized, double-blind study of nevirapine administered to pregnant HIV-1 infected women during labor, and to their neonates between 48 and 72 hours of age. The primary endpoint is the incidence of HIV-1 transmission from mother to infant. The frequency of transmission of HIV-1 from an infected mother to her infant is estimated to be in the range of 15-40%. Evidence suggests that 3 modes of transmission occur: in utero, intrapartum, and postpartum through breast milk. Nevirapine has several properties which make it an ideal candidate antiretroviral therapy to interrupt HIV-1 transmission in the intrapartum and early post-partum period. The pharmacokinetic profile suggested that nevirapine would be rapidly absorbed and transferred to the infant in utero when given during labor and delivery. In addition, nevirapine has been shown to penetrate cell free virions and inactivate virion associated RT in situ. These characteristics have led to a hypothesis that treatment of an HIV-infected pregnant woman in labor with an oral dose of nevirapine may provide a prophylactic level of nevirapine in the infant during the time of exposure to virus in the birth canal and or maternal blood. In addition, nevirapine may inactivatte the virion associated RT present in acell free virions in the genital tract or breast milk.

III期随机双盲研究，奈韦拉平用于分娩期间感染HIV-1的孕妇及其48至72小时大的新生儿。主要终点是HIV-1母婴传播的发生率。艾滋病毒-1从受感染母亲传染给婴儿的频率估计在15-40%之间。有证据表明有三种传播方式：子宫内、产时和产后通过母乳传播。奈韦拉平有几个特性，使其成为一种理想的候选抗逆转录病毒疗法，以中断HIV-1在产时和产后早期的传播。药代动力学分析表明，奈韦拉平在分娩和分娩期间给药可迅速吸收并转移到子宫内的婴儿体内。此外，奈韦拉平已被证明可以穿透无细胞病毒粒子，并在原位灭活病毒粒子相关的RT。这些特征导致了一种假设，即对感染艾滋病毒的临产孕妇进行口服剂量的奈韦拉平治疗，可能会在婴儿在产道和/或母体血液中接触病毒期间提供预防水平的奈韦拉平。此外，奈韦拉平可能使生殖道或母乳中无细胞病毒粒子中存在的病毒粒子相关RT失活。