The Evaluation of Subcutaneous Proleukin® (interleukin-2) in a Randomized International Trial:: rationale, design, and methods of ESPRIT
The Evaluation of Subcutaneous Proleukin® (interleukin-2) in a Randomized International Trial:: rationale, design, and methods of ESPRIT
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DOI：
10.1016/s0197-2456(01)00179-9
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发表时间：
2002-04-01
期刊：
影响因子：
--
通讯作者：
Neaton, JD
中科院分区：
文献类型：
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作者：
Emery, S;Abrams, DI;Neaton, JD
皮下注射Proleukin（R）在随机国际试验中的评价（ESPRIT）是一项正在进行的大型随机试验，在CD 4细胞计数至少为300个细胞/mm的HIV（人类免疫缺陷病毒）疾病患者中比较皮下注射白细胞介素-2（IL-2）加抗逆转录病毒治疗与单独抗逆转录病毒治疗（3）。主要目的是确定在联合抗逆转录病毒治疗中加入IL-2是否能改善发病率和死亡率。目标是招募4000名参与者，并跟踪他们平均5年。将在全球23个国家的275家研究中心招募合格受试者。再加上广泛的资格标准，这将确保广泛适用的结果。在这种情况下，还将讨论一系列次要目的，包括开展以公共卫生为重点的观察性研究和嵌套子研究。本文描述了支持试验的基本原理，并回顾了研究设计、协调和管理。(C)2002年爱思唯尔科技有限公司All rights reserved.
The Evaluation of Subcutaneous Proleukin(R) in a Randomized International Trial (ESPRIT) is a large ongoing randomized trial of subcutaneous interleukin-2 (IL-2) plus antiretroviral therapy versus antiretroviral therapy alone in patients with HIV (human immunodeficiency virus) disease and CD4 cell counts of at least 300 cells/mm(3). The primary objective is to determine whether the addition of IL-2 to combination antiretroviral therapy improves morbidity and mortality. The aim is to recruit 4000 participants and follow them for an average of 5 years. Eligible subjects will be recruited at 275 investigational sites in 23 countries around the world. Coupled with broad eligibility criteria this will ensure widely applicable results. A range of secondary objectives will also be addressed in this setting that will include the conduct of observational studies and nested substudies with a public health focus. This article describes the rationale supporting the trial in addition to reviewing the study design, coordination, and governance. (C) 2002 Elsevier Science Inc. All rights reserved.