ACTG 353, V 2--NELFINAVIR COADMINISTERED W/ ZIDOVUDINE & LAMIVUDINE

这是一项I期、开放标签、多次给药、奈非那韦、齐多夫定（ZDV）和拉米夫定（3 TC）联合研究。 将在妊娠、分娩和分娩期间以及产后对HIV感染的孕妇及其婴儿进行联合给药。 尽管如ACTG 016试验中所报告的，通过向母亲施用ZDV，围产期HIV传播减少2/3的显著结果，但仍需要开发新的和更有效的策略来进一步减少围产期传播。 几项研究的数据表明，母亲的产前治疗可能是最重要的。 已知ZDV可使病毒载量平均降低0.5 log，尽管这可能因个体而异。 组合的抗逆转录病毒药物如ZDV和3 TC可以将病毒载量降低1.5至2个对数，或者使用蛋白酶抑制剂如奈非那韦的三重组合可以将病毒载量降低>或等于2个对数，并降低至低于可检测水平。 在大多数受试者中，可以想象在妊娠期间开始三联治疗可能对将物质病毒载量降至最低水平具有最有效的作用，在许多情况下，在分娩前降至不可检测的水平。 (ACTG 353，V. 2）

This is a phase I, open label, multiple dose, combination study of Nelfinavir, Zidovudine (ZDV), and Lamivudine (3TC). The combination will be administered to HIV infected pregnant women during pregnancy, labor and delivery, and postpartum and to their infants. Despite dramatic results of a 2/3 reduction of perinatal HIV transmission by administration of ZDV to mothers as reported in ACTG 016 trial, there is a need to develop new and more potent strategies to further reduce perinatal transmission. Data from several studies suggest that the prenatal treatment of the mother may be most important. ZDV is known to reduce the viral load on an average of 0.5 log, although this can vary between individuals. Combined antiretrovirals such as ZDV and 3TC can reduce virus load by 1.5 to 2 logs or triple combinations using protease inhibitors such as Nelfinavir can reduce viral load by > or equal to 2 logs and to below detectable levels. In a majority of subjects it is conceivable that initiation of treatment with triple combination during gestation may have the most potent effect on reduction of material virus load to its lowest, and in many cases, to undetectable levels prior to delivery. (ACTG 353, V. 2)