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

Sean Emery, Donald I. Abrams, David A. Cooper, Janet H. Darbyshire, H. Clifford Lane, Jens D. Lundgren, James D. Neaton

Research output: Contribution to journalArticlepeer-review

75 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)198-220
Number of pages23
JournalControlled clinical trials
Volume23
Issue number2
DOIs
StatePublished - 2002

Keywords

  • Clinical endpoint study
  • HIV
  • Interleukin-2

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