CLINICAL TRIAL: OPEN-LABEL, PH II STUDY OF INTERLEUKIN-2 AND ANTIRETROVIRAL THER

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。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。 目的：比较随机分配至未接受治疗、皮下注射rIL-2单药治疗或皮下注射rIL-2联合围周期HAART治疗的患者32周后CD 4 T淋巴细胞较基线的变化。 研究报告：这是一项在CD 4 T细胞计数至少为300个细胞/mm 3的无症状HIV感染患者中进行的多中心、II期开放标签研究，比较了皮下注射rIL-2单独给药与仅在rIL-2周期内给予rIL-2 + HAART与无治疗。 将有三个治疗组。 提供知情同意书的合格患者将接受随机化。 方法：共入组480例患者。 A组，160名患者，将被随机分配，不接受任何治疗。 组B，160例患者，将随机接受rIL-2（7.5 MIU sc q12小时x5天q8周x3个周期，然后根据需要持续8周以维持计数达到或高于目标）。 C组，160例患者，将随机接受rIL-2（7.5 MIU sc q12小时x5天q8周x3个周期，然后根据需要q8周以维持计数达到或高于目标）+ HAART（rIL-2周期前3天，期间5天和后2天）。 将对患者进行随访，直至最后一例患者随机化后12个月的共同结束日期。 临床相关性：IL-2是一种T细胞生长因子。 HIV疾病的特征在于抗原诱导的IL-2产生受损。 CD 4 + T细胞的进行性耗竭与机会性感染的风险增加有关，并且是HIV疾病的标志。 当以间歇时间表给予时，IL-2可导致CD 4 + T细胞池的选择性扩增。 这些CD 4 + T细胞似乎是功能性的。 IL-2可能延迟HAART的使用、机会性感染、死亡和其他AIDS定义事件的发生。

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. OBJECTIVE: To compare the change from baseline in CD4 T lymphocyte after 32 weeks in groups of patients randomly assigned to receive no therapy, subcutaneous rIL-2 monotherapy or subcutaneous rIL-2 with peri-cycle HAART. RESEARCH PLAN: This is a multi-site, phase II open label study of subcutaneous rIL-2 alone vs rIL-2 plus HAART administered only during rIL-2 cycles vs. no therapy in asymptomatic, HIV-infected patients with a CD4 T cell count of at least 300 cell/mm3. There will be three treatment arms. Eligible patients who provide consent will be randomized. METHODS: A total of 480 patients will be enrolled. Group A, 160 patients, will be randomized with no therapy. Group B, 160 patients, will be randomized with rIL-2 (7.5 MIU sc q12 hours x 5 days q8 weeks x 3 cycles, then a8 weeks as needed to maintain counts at or above goal). Group C, 160 patients, will be randomized with rIL-2 (7.5 MIU sc q12 hours x 5 days q8 weeks x 3 cycles, then q8 weeks as needed to maintain counts at or above goal) + HAART (3 days prior to, 5 days during, and 2 days after rIL-2 cycle). Patients will be followed until a common closing date which will be 12 months after the last patient is randomized. CLINICAL RELEVANCE: IL-2 is a T-cell growth factor. HIV disease is characterized by an impairment of antigen-induced IL-2 production. Progressive depletion of CD4+ T-cells is associated with an increased risk of opportunistic infections, and is the hallmark of HIV disease. When given on an intermittent schedule, IL-2 can lead to selective expansion of the CD4+ T-cell pool. These CD4+ T-cells appear to be funcitonal. Il-2 may have the potential to delay the use of HAART, the development of opportunistic infections, death, and other AIDS-defining events.