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

这个子项目是许多研究子项目中的一个 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。列出的机构是 研究中心，而研究中心不一定是研究者所在的机构。 A5068是一项随机I/II期初步研究，旨在评价间歇性停用强效抗逆转录病毒治疗作为免疫策略、ALVAC-HIV免疫以及两种策略联合使用的安全性、抗病毒作用和免疫学作用。主要目标是 比较不同抗原刺激方法的效果（间歇性强效ART停药vs ALVAC vs两者）vs无抗原刺激，在强效ART停药终点读出期（步骤6）的最后2周内的log 10 HIV-1 RNA拷贝/mL平均值，并确定在持续性CD 4+受试者中间歇性停用抗逆转录病毒治疗（有或无HIV特异性疫苗）的安全性。T细胞计数>400/mm 3，持续血浆HIV-1 RNA水平<50拷贝/mL。 受试者将以相同数量（每组25例）随机分配至4个组之一： A组：安慰剂免疫（ALVAC安慰剂）+强效ART，持续92周，有一个12- 20周的停药期。 B组：安慰剂免疫（ALVAC安慰剂）+强效ART，持续84周，包括1个4- 6周停药期、1个4周停药期和1个12- 20周停药期。 C组：疫苗免疫（ALVAC vCP 1452）+强效ART，持续92周，包括一个12- 20周的停药期。 D组：疫苗免疫（ALVAC vCP 1452）+强效ART，持续84周，包括1个4- 6周停药期、1个4周停药期和1个12- 20周停药期。

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.