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

Emery, Sean; Abrams, Donald I.; Cooper, David A.; Darbyshire, Janet H.; Lane, H.Clifford; Lundgren, Jens D.; Neaton, James D.; the ESPRIT Study Group
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See appendix for members of the ESPRIT study group.,

« PreviousControlled Clinical Trials
Volume 23, Issue 2 , Pages 198-220, April 2002

The Evaluation of Subcutaneous Proleukin^® (interleukin-2) in a Randomized International Trial:

rationale, design, and methods of ESPRIT

Sean Emery, Ph.D.
- National Centre in HIV Epidemiology and Clinical Research, University of New South Wales, Sydney, Australia
- Corresponding author: Dr. Sean Emery, National Centre in HIV Epidemiology and Clinical Research, University of New South Wales, Level 2, 376 Victoria Street, Sydney, NSW 2010, Australia. Tel.: +61-2-9332-4648; Fax: +61-2-9332-1837
Donald I. Abrams, M.D.
- University of California, San Francisco, CA, USA
David A. Cooper, M.D., D.Sc.
- National Centre in HIV Epidemiology and Clinical Research, University of New South Wales, Sydney, Australia
Janet H. Darbyshire, O.B.E., F.R.C.P.
- MRC Clinical Trials Unit, University College London Medical School, London, United Kingdom
H.Clifford Lane, M.D.
- National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA
Jens D. Lundgren, M.D., D.M.Sc.
- Department of Infectious Diseases, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark
James D. Neaton, Ph.D.
- Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA
the ESPRIT Study Group

Received 6 March 2001; accepted 21 August 2001.

manuscript

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.

Keywords: Interleukin-2, HIV, Clinical endpoint study