ANTIRETROVIRAL EFFECT OF IMMUNIZATION WITH THE MRK AD5 HIV-1 GAG VACCINE

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这是一项II期随机、双盲、多中心、安慰剂对照研究，旨在确定在抗逆转录病毒治疗(ART)中断后，抗逆转录病毒免疫疗法(ARI)引发的免疫反应是否能够维持病毒抑制。这项研究将分四个阶段进行：1)免疫阶段(步骤I)，2)为期16周的抗逆转录病毒治疗中断阶段(步骤II)，3)后续阶段，要么继续所有抗逆转录病毒疗法的中断(步骤III)，要么恢复抗逆转录病毒疗法(步骤IV)，以及4)长期安全后续阶段(步骤V)。在第一步中接受抗逆转录病毒治疗时，受试者将接受一系列的三次免疫，接种MRK Ad5 HIV-1 Gag疫苗或安慰剂。在免疫阶段之后，所有符合标准的受试者都将进入第二步，并将接受临床、免疫学和病毒学跟踪。在为期16周的艺术中断阶段之后，受试者将可以选择恢复艺术或继续停止艺术。。步骤II/III的受试者，如果HIV-1RNA连续三次为？300,000拷贝/毫升，或确认(定义为两个连续值)CD4+细胞计数为基线的50%，将强烈鼓励受试者恢复抗逆转录病毒治疗(有关详细信息，请参见第3.0节)。在第三步或第四步完成后，或在第一步最后一次检查之后(如果不符合第二步的条件)，将对受试者进行长期安全评估(第五步)。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a phase II, randomized, double-blind, multicenter, placebo-controlled study designed to determine if the immune responses elicited by antiretroviral immunotherapy (ARI) are capable of maintaining viral suppression following interruption of antiretroviral therapy (ART). The study will be conducted in four phases: 1) an immunization phase (Step I), 2) a 16-week ART interruption phase (Step II), 3) a follow-up phase, either continuation of the interruption of all ART (Step III) or resumption of ART (Step IV), and 4) a long-term safety follow-up phase (Step V). While on ART in Step I, subjects will receive a series of three immunizations with the MRK Ad5 HIV-1 Gag vaccine or placebo. After the immunization phase, all subjects who meet the criteria will enter Step II and will be followed clinically, immunologically, and virologically. After the 16-week ART interruption phase, subjects will have the option to resume ART or continue off ART. . Subjects on Step II/III whose HIV-1 RNA is ? 300,000 copies/mL three consecutive times or who have a confirmed (defined as two consecutive values) CD4+ cell count of 50% from baseline will be strongly encouraged to resume ART (see section 3.0 for further details). After completion of Step III or Step IV or after the last visit on Step I (if ineligible for Step II) subjects will be followed for long-term safety assessments (Step V).