PHASE I/II TRIAL OF RECOMBINANT INTERLEUKIN 2 IN SYMPTOMATIC HIV INFECTED CHILD

在有症状的 HIV 感染儿童中进行重组白细胞介素 2 的 I/II 期试验

• 批准号: 6114989
• 负责人: ELIZABETH G MCFARLAND
• 金额: $ 1.99万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6114989
• 关键词: AIDS therapy; HIV infections; biomarker; blood cell count; clinical research; clinical trial phase I; dosage; drug administration rate /duration; drug screening /evaluation; drug tolerance; helper T lymphocyte; human subject; human therapy evaluation; interleukin 2; microorganism disease chemotherapy; pediatric AIDS; pediatric pharmacology; recombinant proteins

This multicenter phase I/II open label study is to be performed in two stages sponsored by the ACTG. Part A will determine the maximally tolerated dose of rIL-2. Part B will treat 15 subjects with the MTD for 5 days every 8 weeks for 3 cycles. The primary objective is to determine the safety of rIL-2 when given to a larger number of children. Secondary objectives are to determine the effects of CD4 cell counts, viral load, and other immumnologic markers.

这项多中心 I/II 期开放标签研究将由 ACTG 赞助分两个阶段进行。 A 部分将确定 rIL-2 的最大耐受剂量。 B 部分将治疗 15 名 MTD 受试者，每 8 周治疗 5 天，共 3 个周期。 主要目标是确定将 rIL-2 给予大量儿童时的安全性。 次要目标是确定 CD4 细胞计数、病毒载量和其他免疫学标志物的影响。