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

CPRA 059：2 剂皮下重组 IL 2 对病毒的影响

• 批准号: 6265785
• 负责人: CHERYL L BESCH
• 金额: $ 1.12万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-07-19 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6265785
• 关键词: AIDS therapy; HIV infections; clinical research; dosage; drug screening /evaluation; human subject; human therapy evaluation; interleukin 2; virus replication

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.

这是一项随机开放标签试验研究，比较两种剂量的皮下（SC）重组IL-2 （IL-2）和无IL-2对HIV-1感染患者的HIV病毒负荷和CD4+细胞计数的影响，以及绝对CD4细胞计数为bbb350 /mm3。在随机分组之前，研究参与者要么正在接受抗逆转录病毒治疗，要么正在开始抗逆转录病毒治疗。如果SC rIL-2的国际III期临床终点试验得以实施，将强烈鼓励入组该CPCRA研究的患者在国际研究中入组并接受持续治疗和随访。总样本量为460例。230名患者将随机接受两种剂量的SC - il -2治疗（4.5 MIU或7.5 MIU，每天两次），230名患者将随机接受不接受SC - il -2治疗，预计入组期为12个月。