INTERLEUKIN 2 BY SUBCUTANEOUS INJECTION COMBINED WITH ANTIRETROVIRAL THERAPY

ACTG 248是一项多中心、随机、开放标签试验， IL-2联合持续抗逆转录病毒治疗方案 与单独抗逆转录病毒治疗相比，在CD 4+细胞计数受试者中 300-700个细胞/mm 3和至少连续3个月稳定的抗逆转录病毒 在入组前立即进行治疗。 共104名受试者将 参加了这项研究。 然后受试者将随机接受开放式 标记IL-2（100万IU/d）B旋转部位皮下感染 加持续抗逆转录病毒治疗与持续抗逆转录病毒治疗 单独治疗。 初始治疗期（步骤1）的持续时间将 是24周。 开始研究药物治疗后， 包括通过皮下注射自我给药说明， IL-2治疗组，受试者将根据 第4.2节和第4.5节概述的时间表。 该试验计划 完全是门诊研究。 在每次研究访视时，受试者将 监测毒性或不良事件的迹象。 剂量减少 IL-2的浓度将用于主观或客观毒性。 所有 中断抗逆转录病毒治疗的受试者必须停用IL-2， 同期业绩免疫学和病毒学标志物以及其他 将按照第4.2节所述进行实验室评价 到4.5。

ACTG 248 is a multi-center, randomized, open-label trial of a single dose regimen of IL-2 in combination with continued antiretroviral therapy versus antiretroviral therapy alone i subjects with CD4+ cell count 300-700 cells/mm3 and at least 3 consecutive months stable antiretroviral therapy immediately preceding enrollment. A toal of 104 subjects will be enrolled into this study. Subjects willthen be randomized to receive open label IL-2 (1 million IU/d) b subcutaneous infection to rotating sites plus continued antiretroviral therapy versus continued antiretroviral therapy alone. the duration of the initial treatment period (Step 1) will be for 24 weeks. After initiation of the study medications, which will include instructions in self-administration by subcantaneous injection for the IL-2 treatment group, subjects will be followed according the the schedule outlined in Sections 4.2 throught 4.5. This trial is planned to be an entirely outpatient study. At each study visit, subjects will be monitored for indications of toxicity or adverse events. Dosage reduction of IL-2 will be employed for subjective or objective toxicities. All subjects who interrupt antiretroviral therapy must discontinue IL-2 for the same period. Immunologic and virologic markers as well as other laboartory evaluations will be performed as outlined in Sections 4.2 through 4.5.