CLINICAL TRIAL: ACTG A5197: ANTIRETROVIRAL EFFECT OF IMMUNIZATION WITH THE MRK A

临床试验：ACTG A5197：MRK A 免疫的抗逆转录病毒作用

• 批准号: 7718417
• 负责人: JUDITH Ann ABERG
• 金额: $ 0.96万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2009-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7718417
• 关键词: Adenoviruses; Anti-Retroviral Agents; Autologous; CD4 Lymphocyte Count; CD8-Positive T-Lymphocytes; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Data; Drops; End Point; Enrollment; Evaluation; Funding; GAG Gene; Gagging; Grant; HIV; HIV-1; Immunization; Immunology procedure; Immunosuppression; Individual; Institution; Interruption; Measurement; Monitor; Patients; Placebos; RNA; Randomized; Research; Research Personnel; Resources; Restart; Safety; Source; Symptoms; Therapeutic immunosuppression; Time; United States National Institutes of Health; Vaccines; Week; antiretroviral therapy; clinically significant; design; vector

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 hypothesizes that stimulation of HIV gag-specific CD8 cells by an Adenovirus-HIVgag vector (Ad5 HIV-1 GAG) will result in better virologic control of autologous HIV in individuals who had previously suppressed HIV replication for >24 months with antiretroviral therapy. Design: Step 1 - A Merck vaccine or placebo (120 patients randomized in 2:1 ratio to these treatments) is delivered at 0, 4, and 26 weeks; this is followed by a 16-week antiretroviral treatment interruption and monitored for safety by frequent CD4 and HIV RNA measurements (step 2). If the subjects choose to remain off antiretroviral therapy (ART), they continue off ART for additional 8-week renewable intervals (up to 32 weeks). If they (or their clinician) choose to resume ART (recommended criteria are CD4 count drops to <50% of baseline, <300, or HIV RNA>300,000 3 consecutive times, signs or symptoms of clinically significant immunosuppression), they enroll in step 4, restarting ART with evaluations at 8-week intervals (up to week 87 of the study). There is a long-term safety step (5), which evaluates patients every 6 months. Endpoints: Primary - the HIV RNA setpoint (determined by the mean of the log copies/ml at weeks 12 and 16 of step 2 and the RNA values at all evaluations during step 2. Secondary endpoints include changes in setpoint, a variety of HIV-specific immunologic assays, and safety data.

该子项目是利用 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。 本研究假设，腺病毒-HIVgag载体（Ad 5 HIV-1 GAG）刺激HIV gag特异性CD 8细胞，将在既往使用抗逆转录病毒治疗抑制HIV复制>24个月的个体中更好地控制自体HIV病毒。 设计图：第1步-在第0、4和26周时给予默克疫苗或安慰剂（120名患者以2：1的比例随机分配至这些治疗）;随后中断16周的抗逆转录病毒治疗，并通过频繁的CD 4和HIV RNA测量监测安全性（第2步）。 如果受试者选择继续停止抗逆转录病毒治疗（ART），则他们继续停止ART额外的8周可更新间隔（最多32周）。如果他们（或他们的临床医生）选择重新开始ART（推荐的标准是CD 4计数下降到基线的50%，<300，或HIV RNA> 300，000连续3次，临床显著免疫抑制的体征或症状），他们参加第4步，重新开始ART，每隔8周进行评估（直至研究的第87周）。 有一个长期安全性步骤（5），每6个月对患者进行一次评估。 终点：主要-HIV RNA设定点（通过步骤2第12周和第16周的log拷贝/ml和步骤2期间所有评价的RNA值的平均值确定）。 次要终点包括设定点的变化、各种HIV特异性免疫测定和安全性数据。