The Evaluation of Subcutaneous Proleukin® (interleukin-2) in a Randomized International Trial: Rationale, design, and methods of ESPRIT

Emery, S, Abrams, DI, Cooper, DA, Darbyshire, JH, Lane, HC, Lundgren, JD and Neaton, JD (2002) The Evaluation of Subcutaneous Proleukin® (interleukin-2) in a Randomized International Trial: Rationale, design, and methods of ESPRIT. Controlled Clinical Trials, 23 2: 198-220. doi:10.1016/S0197-2456(01)00179-9


Author Emery, S
Abrams, DI
Cooper, DA
Darbyshire, JH
Lane, HC
Lundgren, JD
Neaton, JD
Title The Evaluation of Subcutaneous Proleukin® (interleukin-2) in a Randomized International Trial: Rationale, design, and methods of ESPRIT
Journal name Controlled Clinical Trials   Check publisher's open access policy
ISSN 0197-2456
1559-2030
Publication date 2002-04-01
Sub-type Article (original research)
DOI 10.1016/S0197-2456(01)00179-9
Open Access Status Not yet assessed
Volume 23
Issue 2
Start page 198
End page 220
Total pages 23
Place of publication Philadelphia, PA, United States
Publisher Elsevier
Language eng
Formatted abstract
The Evaluation of Subcutaneous Proleukin® 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/mm3. 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.
Keyword Clinical endpoint study
HIV
Interleukin-2
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Medicine Publications
 
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