CPCRA 059:IMPACT OF 2 DOSES OF SUBCUTANEOUS RECOMBINANT IL 2 ON VIRAL

这是一项随机开放标签试验研究，旨在比较两种剂量的皮下（SC）重组IL-2（rIL-2）和无rIL-2对HIV-1感染和绝对CD 4细胞计数> 350/mm 3的患者中HIV病毒负荷和CD 4+细胞计数的影响。 研究受试者将在随机化前正在接受或开始接受抗逆转录病毒治疗。 如果SC rIL-2的国际III期临床终点试验得以实施，将强烈鼓励入组本CPCRA研究的患者入组并在国际研究中继续接受治疗和随访。 总样本量为460例患者。 在12个月的预期入组期内，230例患者将随机接受两种剂量的SC rIL-2治疗（4.5 MIU或7.5 MIU，每日两次）之一，230例患者将随机接受无SC rIL-2治疗。

This is a randomized open-label trial study to compare the effects of two doses of subcutaneous (SC) recombinant IL-2 (rIL-2) and no rIL-2 on HIV viral burden and CD4+ cell count in patients with HIV-1 infection and absolute CD4 cell counts of > 350/mm3. Study participants will be either currently receiving or initiating antiretroviral treatment prior to randomization. If the international phase III clinical endpoint trial of SC rIL-2 is implemented, patients enrolled in this CPCRA study will be strongly encouraged to enroll and receive continued treatment and follow-up in the international study. The total sample size is 460 patients. Two hundred and thirty patients will randomized to one of two doses of SC rIL-2 therapy (4.5 MIU or 7.5 MIU twice daily), and 230 patients will be randomized to no SC rIL-2 over an anticipated enrollment period of 12 months.