A PHASE II DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项研究旨在确定抗逆转录病毒免疫治疗(ARI)引起的免疫反应在抗逆转录病毒治疗(ART)中断后是否能够维持病毒抑制。在研究的免疫阶段之后，将有一个为期16周的抗逆转录病毒治疗中断阶段。然后，受试者将进入后续阶段，在此期间，他们要么继续中断，要么恢复艺术。这之后将是一个长期的安全后续阶段。受试者将接受MRK Ad5 HIV-Gag疫苗或安慰剂的一系列三次免疫。研究持续时间约为240周，主要研究评估将进行到第87周，后续工作将再进行约150周。样本规模将为120名受试者，参与者按2：1的比例随机接种疫苗；预计最多有10名受试者在当地登记。

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 study has been designed to determine if the immune responses elicited by antiretroviral immunotherapy (ARI) are capable of maintaining viral suppression following interruption of antiretroviral therapy (ART). Following the immunization phase of the study, there will be a 16-week ART interruption phase. Subjects will then enter a follow-up phase during which time they will either continue the interruption or will resume ART. This will be followed by a long-term safety follow-up phase. Subjects will receive a series of three immunizations with the MRK Ad5 HIV-gag vaccine or a placebo. The study duration will be approximately 240 weeks with the main study evaluations being conducted through week 87 with follow-up occurring for approximately 150 additional weeks. The sample size will be 120 subjects with participants being randomized to the vaccine at a 2 to 1 ratio; up to ten subjects are expected to enroll locally.