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

ACTG 299是一项重组白细胞介素-2 （il -2）在3-12岁hiv感染儿童中的I/II期剂量递增试验。A部分的主要目的是确定感染艾滋病毒的儿童中il -2的安全和耐受剂量。对于B部分，主要目标是确定以a部分受试者耐受的剂量给予大量hiv感染儿童il -2的安全性。次要目标如下：a部分：确定不同剂量的il -2对CD4细胞计数的影响，并确定il -2给药对病毒载量的影响。B部分：确定il -2给药对a)抗原和丝裂原诱导的淋巴细胞增殖以及细胞毒性T和NK细胞反应的影响；b) HLA-DR和CD38在CD4和CD8细胞上的表达；C)病毒载量；d) CD4细胞计数；e)初始和记忆CD4和CD8细胞数量；E)外周血单个核细胞凋亡。

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.