title: The evaluation of subcutaneous proleukin (interleukin-2) in a randomized international trial: rationale, design, and methods of ESPRIT.
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/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.
authors.affiliation: National Centre in HIV Epidemiology and Clinical Research, University of New South Wales, Level 2, 376 Victoria Street, Sydney, NSW 2010, Australia. semery@nchecr.unsw.edu.au
authors.forename: Sean
authors.initials: S
authors.lastname: Emery
authors.forename: Donald I
authors.initials: DI
authors.lastname: Abrams
authors.forename: David A
authors.initials: DA
authors.lastname: Cooper
authors.forename: Janet H
authors.initials: JH
authors.lastname: Darbyshire
authors.forename: H Clifford
authors.initials: HC
authors.lastname: Lane
authors.forename: Jens D
authors.initials: JD
authors.lastname: Lundgren
authors.forename: James D
authors.initials: JD
authors.lastname: Neaton
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use; D017326:Clinical Trials, Phase III as Topic / Q000379:methods; D003625:Data Collection / Q000379:methods; D018450:Disease Progression; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D007279:Injections, Subcutaneous; D007376:Interleukin-2 / Q000627:therapeutic use*; D008297:Male; D015337:Multicenter Studies as Topic / Q000379:methods; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000191:economics / Q000379:methods* / Q000706:statistics & numerical data; D012107:Research Design; D018401:Sample Size; D016019:Survival Analysis; D014481:United States
chemical_list: D019380:Anti-HIV Agents; D007376:Interleukin-2