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

这是奈非那韦、齐多夫定（ZDV）和拉米夫定（3TC）的I期、开放标签、多剂量联合研究。该组合将用于感染艾滋病毒的孕妇在怀孕、分娩和产后及其婴儿。尽管ACTG 016试验报告，通过给母亲注射ZDV，围产期艾滋病毒传播减少了2/3，但仍需要制定新的和更有效的战略来进一步减少围产期艾滋病毒传播。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平均降低0.5 log的病毒载量，尽管这在个体之间可能有所不同。ZDV和3TC等联合抗逆转录病毒药物可将病毒载量减少1.5至2 log，或使用奈非那韦等蛋白酶抑制剂的三联用药可将病毒载量减少100万log或等于2 log并低于可检测水平。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具有最有效的效果，在许多情况下，在分娩前降至无法检测到的水平。（使徒行传353章2节）

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)