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

MRK AD5 HIV-1 GAG 疫苗免疫的抗逆转录病毒作用

• 批准号: 7381027
• 负责人: Jorge Santana
• 金额: $ 2.02万
• 依托单位: UNIVERSITY OF PUERTO RICO MED SCIENCES
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-07-01 至 2007-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7381027
• 关键词: ANTIRETROVIRAL; EFFECT; IMMUNIZATION; MRK; AD5

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).

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。这是一项II期、随机、双盲、多中心、安慰剂对照研究，旨在确定抗逆转录病毒免疫治疗（ARI）引起的免疫应答是否能够在中断抗逆转录病毒治疗（ART）后维持病毒抑制。研究将分四个阶段进行：1）免疫接种阶段（步骤I），2）16周ART中断阶段（步骤II），3）随访阶段，继续中断所有ART（步骤III）或恢复ART（步骤IV），以及4）长期安全性随访阶段（步骤V）。在步骤I中接受ART治疗时，受试者将接受MRK Ad 5 HIV-1 Gag疫苗或安慰剂的一系列三次免疫接种。免疫阶段后，所有符合标准的受试者将进入第II步，并接受临床、免疫学和病毒学随访。在16周ART中断期后，受试者将可以选择恢复ART或继续停止ART。步骤II/III的受试者，其HIV-1 RNA是？强烈鼓励连续三次<300，000拷贝/mL或CD 4+细胞计数较基线确认（定义为连续两个值）> 50%的患者重新开始ART治疗（更多详情见第3.0节）。完成步骤III或步骤IV后或步骤I末次访视后（如果不符合步骤II的条件），将对受试者进行长期安全性评估随访（步骤V）。