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

一项 II 期双盲、随机、安慰剂对照研究来评估

• 批准号: 7717522
• 负责人: MITCHELL J GOLDMAN
• 金额: $ 0.68万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7717522
• 关键词: Anti-Retroviral Agents; Computer Retrieval of Information on Scientific Projects Database; Double-Blind Method; Enrollment; Evaluation Studies; Funding; Gagging; Grant; Immune response; Immunization; Immunotherapy; Institution; Interruption; Participant; Phase; Placebos; Randomized; Research; Research Personnel; Resources; Safety; Sample Size; Series; Source; Time; United States National Institutes of Health; Vaccines; Viral; Week; antiretroviral therapy; design; follow-up; randomized placebo controlled trial

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.

这个子项目是许多利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 本研究旨在确定抗逆转录病毒免疫疗法（ARI）引起的免疫应答是否能够在抗逆转录病毒疗法（ART）中断后维持病毒抑制。 在研究的免疫阶段之后，将有一个16周的ART中断阶段。 然后受试者将进入随访期，在此期间，他们将继续中断或重新开始ART。随后将进入长期安全性随访期。 受试者将接受MRK Ad 5 HIV-gag疫苗或安慰剂的三次免疫接种。 研究持续时间约为240周，主要研究评价将进行至第87周，随访时间约为150周。 样本量为120例受试者，受试者以2：1的比例随机接受疫苗;预计最多10例受试者将在当地入组。