CT 2001 A STAGED PHASE I STUDY OF THE TREATMENT OF MALIGNANT GLIOMA WITH G207,

CT 2001 用 G207 治疗恶性神经胶质瘤的分阶段 I 期研究，

• 批准号: 7603224
• 负责人: JAMES M MARKERT
• 金额: $ 1.16万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603224
• 关键词: ALVAC; Antigens; Antiviral Agents; CD4 Positive T Lymphocytes; Cell Count; Computer Retrieval of Information on Scientific Projects Database; End Point; Funding; G207; Grant; HIV immunization; HIV-1; Immunization; Institution; Malignant Glioma; Methods; Numbers; Phase; Phase I Clinical Trials; Pilot Projects; Placebos; Plasma; RNA; Randomized; Research; Research Personnel; Resources; Safety; Source; Staging; United States National Institutes of Health; Upper arm; Vaccines; Week; Withdrawal; antiretroviral therapy

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. A5068 is a randomized phase I/II pilot study intended to evaluate the safety, antiviral effects and immunological effects of intermittent withdrawal of potent antiretroviral therapy as an immunization strategy, ALVAC-HIV immunization, and the two strategies combined. The primary objectives are to compare the effect of different methods of antigen stimulation (intermittent potent ART withdrawal versus ALVAC versus both) versus no antigen stimulation on the mean of the log10 HIV-1 RNA copies/mL in the last 2 weeks of the endpoint readout period (Step 6) of potent ART withdrawal, and to establish the safety of intermittent withdrawal of antiretroviral therapy with and without HIV-specific vaccine in subjects with persistent CD4+ T-cell counts >400/mm3 and persistent plasma HIV-1 RNA levels <50 copies/mL. Subjects will be randomized in equal numbers (25 per arm) to one of four arms: Arm A: Placebo immunization (ALVAC placebo) + potent ART for 92 weeks with one 12- to 20-week therapy withdrawal period. Arm B: Placebo immunization (ALVAC placebo) + potent ART for 84 weeks with one 4- to 6-week therapy withdrawal period, one 4-week therapy withdrawal period, and one 12- to 20-week therapy withdrawal period. Arm C: Vaccine immunization (ALVAC vCP1452) + potent ART for 92 weeks with one 12- to 20-week therapy withdrawal period. Arm D: Vaccine immunization (ALVAC vCP1452) + potent ART for 84 weeks with one 4- to 6-week therapy withdrawal period, one 4-week therapy withdrawal period, and one 12- to 20-week therapy withdrawal period.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 A5068 是一项随机 I/II 期试点研究，旨在评估间歇性撤除强效抗逆转录病毒治疗作为免疫策略、ALVAC-HIV 免疫以及两种策略相结合的安全性、抗病毒效果和免疫学效果。主要目标是 比较不同抗原刺激方法（间歇性强效 ART 戒断与 ALVAC 与两者）与无抗原刺激对终点读出期最后 2 周内 lo​​g10 HIV-1 RNA 拷贝数/mL 平均值的影响（步骤 6）有效的 ART 戒断，并确定在持续 CD4+ T 细胞计数 >400/mm3 和持续血浆 HIV-1 RNA 的受试者中间歇性戒断使用或不使用 HIV 特异性疫苗的抗逆转录病毒治疗的安全性水平<50拷贝/mL。 受试者将被随机分配到四个组之一（每组 25 名）： A 组：安慰剂免疫（ALVAC 安慰剂）+ 有效 ART，为期 92 周，其中包括 12 至 20 周的停药期。 B 组：安慰剂免疫（ALVAC 安慰剂）+ 有效 ART，为期 84 周，其中包括 1 个 4 至 6 周的治疗停药期、1 个 4 周的治疗停药期和 1 个 12 至 20 周的治疗停药期。 C 组：疫苗免疫 (ALVAC vCP1452) + 有效 ART，为期 92 周，其中包括 12 至 20 周的停药期。 D 组：疫苗免疫 (ALVAC vCP1452) + 有效 ART，持续 84 周，其中包括 1 个 4 至 6 周的停药期、1 个 4 周的停药期和 1 个 12 至 20 周的停药期。