SALVAGE ANTIRETROVIRAL THERAPIES FOR HIV INFECTED INDIVIDUALS

一项II期、随机、开放标签、4组试验，比较了有奈非那韦治疗失败病毒学证据且未接受过非核苷类逆转录酶抑制剂和以下至少一种核苷类逆转录酶抑制剂联合治疗的两种组分的HIV感染受试者的双重和单一蛋白酶抑制剂挽救性抗逆转录病毒治疗：1）ZDV和3TC，2）d4T和3TC，3）d4T和ddI，或4）ZDV和ddI。 合格受试者将以开放标签方式随机分配至4个治疗组。 将对血浆HIV RNA进行真实的定量，并密切监测研究的早期病毒学终点。 在40个研究终点发生后进行中期分析，以确定表现不佳或耐受性差的组。每增加40个终点后，将重复进行中期分析。

A Phase II randomized, open-label, 4-arm trial comparing dual and single protease inhibitor salvage antiretroviral therapies for HIV infected subjects who have virologic evidence of nelfinavir treatment failure and who are naive to non-nucleoside reverse transcriptase inhibitors and to both components of at least one of the following nucleoside reverse transcriptase inhibitors combinations: 1) ZDV and 3TC, 2) d4T and 3TC, 3) d4T and ddI, or 4) ZDV and ddI. Eligible subjects will be randomized in an open-label fashion to the 4 treatment arms. Plasma HIV RNA will be quantified in real time and the study monitored closely for early virologic endpoints. An interim analysis will be performed after 40 study endpoints have occurred to identify underperforming or poorly tolerated arms. Interim analyses will be repeated after each additional 40 endpoints.