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.

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。 A5068是一项随机的I/II阶段试点研究，旨在评估间歇停用有效的抗逆转录病毒治疗作为免疫策略、ALVAC-HIV免疫以及这两种策略联合使用的安全性、抗病毒效果和免疫学效果。主要目标是 比较不同的抗原刺激方法(间歇性有效ART停药与ALVAC或两者兼而有之)和无抗原刺激对有效停用ART终止期(步骤6)的最后两周内log10个HIV-1RNA拷贝/毫升的影响，并建立在持续的CD4+T细胞计数和持续的血浆HIV-1RNA水平为50拷贝/毫升的受试者中，间歇性停用抗逆转录病毒治疗的安全性。 受试者将被随机分配到以下四组中的一组： A组：安慰剂免疫(ALVAC安慰剂)+有效的ART，为期92周，一个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，其中包括一个4-6周的停药期、一个4周的停药期和一个12-20周的停药期。 C组：疫苗免疫(ALVAC VCP1452)+有效抗逆转录病毒治疗92周，停药12至20周。 D组：疫苗免疫(ALVAC VCP1452)+有效ART，为期84周，其中包括一个4-6周的停药期、一个4周的停药期和一个12-20周的停药期。