Immunologic and virologic effects of subcutaneous interleukin 2 in combination with antiretroviral therapy - A randomized controlled trial
Immunologic and virologic effects of subcutaneous interleukin 2 in combination with antiretroviral therapy - A randomized controlled trial
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DOI：
10.1001/jama.284.2.183
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发表时间：
2000-07-12
影响因子：
120.7
通讯作者：
Kahn, JO
中科院分区：
文献类型：
--
作者：
Davey, RT;Murphy, RL;Kahn, JO
背景虽然白细胞介素2（IL-2）能够诱导CD 4 T淋巴细胞池的显著扩增，IL-2治疗是否能显著增加有效抗逆转录病毒治疗（ART）的免疫学和病毒学效应，目前存在有限的数据。目的确定当使用IL-2联合治疗时，CD 4细胞恢复和病毒抑制的速率和幅度。2和ART合并单独ART。设计和设置随机，从1996年4月到1998年4月在美国8个临床地点进行的对照多中心试验。患者82名感染人类免疫缺陷病毒（HIV）且基线CD 4细胞计数200 × 10（6）/随机抽取78名患者，其中39名患者随机接受IL-2皮下注射联合治疗，另39名患者随机接受IL-2皮下注射联合治疗，其中39名患者随机接受IL-2皮下注射联合治疗，另39名患者随机接受IL-2皮下注射联合治疗，其中39名患者随机接受IL-2皮下注射联合治疗，另39名患者随机接受IL-2皮下注射联合治疗。（每8周以7.5 mIU每天两次的起始剂量以5天疗程施用）和ART;主要结果测量白细胞介素2的安全性和对CD 4细胞计数，CD 4细胞百分比，结果接受IL-2治疗的患者在1年时CD 4细胞计数的平均（SD）百分比增加为112%（113%）。而单独接受抗逆转录病毒治疗的患者为18%（35%）（P
Context While interleukin 2 (IL-2) is capable of inducing a marked expansion of the CD4 T-lymphocyte pool, limited data exist on whether IL-2 treatment can add significantly to the immunologic and virologic effects of potent antiretroviral therapy (ART).Objective To determine the rate and magnitude of CD4 cell recovery and viral suppression when using a combination therapy of IL-2 and ART com pared with ART alone.Design and Setting Randomized, controlled multicenter trial conducted from April 1996 through April 1998 at 8 clinical sites in the United States.Patients Eighty-two adult outpatients who were infected with human immunodeficiency virus (HIV) and had baseline CD4 cell counts of 200 x 10(6)/L to 500 x 10(6)/L and baseline RNA levels of fewer than 10 000 copies/mL were randomized; 78 completed the study.Interventions Thirty-nine patients were randomly assigned to receive a combination therapy of subcutaneous IL-2 (administered in 5-day courses every 8 weeks at a starting dosage of 7.5 mIU twice per day) and ART; 43 were to receive ART therapy alone.Main Outcome Measures Interleukin 2 safety and differential effects on CD4 cell counts, CD4 cell percentages, and plasma HIV RNA levels.Results The mean (SD) percentage increase in CD4 cell counts at 1 year for patients who received IL-2 was 112% (113%) compared with 18% (35%) in recipients of ART alone (P