PHASE III RANDOMIZED BLINDED STUDY OF NEVIRAPINE VS NEVIRAPINE PLACEBO

第三阶段，将奈韦拉平用于分娩期间感染HIV-1的孕妇及其出生48至72小时的新生儿的随机双盲研究。主要终点是艾滋病毒-1从母亲传染给婴儿的发生率。艾滋病毒-1从受感染母亲向其婴儿传播的频率估计在15%至40%之间。有证据表明，有3种传播方式：宫内、产中和产后通过母乳传播。奈韦拉平具有多种特性，使其成为一种理想的抗逆转录病毒疗法，可在产中和产后早期阻断HIV-1的传播。药代动力学分析表明，在分娩和分娩期间给药，奈韦拉平在子宫内会迅速吸收并转移到婴儿体内。此外，奈韦拉平已被证明可以穿透细胞内的游离病毒粒子，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，即对正在分娩的艾滋病毒感染孕妇进行口服剂量的奈韦拉平治疗，可能会在婴儿接触产道和或母亲血液中的病毒期间提供预防性水平的奈韦拉平。此外，奈韦拉平可以灭活生殖道或母乳中ACell游离病毒粒子中存在的病毒粒子相关RT。

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.