ACT 299--RECOMBINANT INTERLEUKIN 2 IN SYMPTOMATIC HIV INFECTED CHILDREN

ACT 299——重组白细胞介素 2 用于有症状的 HIV 感染儿童

• 批准号: 6219834
• 负责人: Stuart E Starr
• 金额: $ 0.06万
• 依托单位: CHILDREN'S HOSP OF PHILADELPHIA
• 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/6219834
• 关键词: AIDS therapy; HIV infections; child (0-11); clinical research; clinical trials; human subject; human therapy evaluation; immunotherapy; interleukin 2; outcomes research; pediatric pharmacology; recombinant proteins

ACTG 299 is a two part, Phase I/II dose-escalating trial of recombinant interleukin-2 (rIL-2) in HIV-infected children ages 3-12 years old. The primary objective of Part A is to determine a safe and tolerated dose of rIL-2 in HIV-infected children. For Part B, the primary objective is to determine the safety of rIL-2 when given to a larger number of HIV-infected children at the dose tolerated by subjects in Part A. Secondary objectives are as follows: Part A: To determine the effect of various doses of rIL-2 on CD4 cell counts and to determine the effect of rIL-2 administration on viral load. Part B: To determine the effect of rIL-2 administration on a) antigen- and mitogen-induced lymphocyte proliferation and on cytotoxic T and NK cell responses; b) expression of HLA-DR and CD38 on CD4 and CD8 cells; c) viral load; d) CD4 cell counts; e) number of naive and memory CD4 and CD8 cells; e) apoptosis of peripheral blood mononuclear cells.

ACTG 299是一项在3-12岁的HIV感染儿童中进行的重组白细胞介素-2（rIL-2）的两部分、I/II期剂量递增试验。 A部分的主要目的是确定HIV感染儿童中rIL-2的安全和耐受剂量。 对于B部分，主要目的是确定在A部分中以受试者耐受的剂量给予大量HIV感染儿童时rIL-2的安全性。次要目的如下：A部分：确定不同剂量的rIL-2对CD 4细胞计数的影响，并确定rIL-2给药对病毒载量的影响。部分B：确定rIL-2给药对a）抗原和有丝分裂原诱导的淋巴细胞增殖以及对细胞毒性T细胞和NK细胞反应的影响; B）CD 4和CD 8细胞上HLA-DR和CD 38的表达; c）病毒载量; d）CD 4细胞计数; e）初始和记忆CD 4和CD 8细胞的数量; e）外周血单核细胞的凋亡。