Evaluation of subcutaneous proleukin (interleukin-2) in a randomized international trial (ESPRIT): Geographical and gender differences in the baseline characteristics of participants

Sarah L. Pett, H. Wand, M. G. Law, R. Arduino, J. C. Lopez, B. Knysz, L. C. Pereira, S. Pollack, P. Reiss, G. Tambussi, Donald I. Abrams, David A. Cooper, Janet H. Darbyshire, William R. Duncan, Sean Emery, H. Clifford Lane, Sandra Lehrman, Jens D. Lundgren, James D. Neaton, Liliana AguilarEleonora Betina Angel, Silvia Aquilia, Waldo Belloso, Jorge Benetucci, Victor Bittar, Pedro Cahn, Arnaldo Casiro, Jorge Contarelli, Jorge Corral, Lucia Daciuk, Daniel David, Ferrari Ines, Diego Fridman, Viviana Galache, Graciela Guaragna, Silvina Ivalo, Hector Laplume, Maria B. Lasala, Roberta Lattes, Jaime Lasovsky, Gustavo Lopardo, Marcelo Losso, Leonardo Lourtau, Sergio Lupo, Aldo Maranzana, Cristina Marson, Lucila Massera, Marisa del Lujan Sanchez, Carla Somenzini, Mariel Tocci, Sally Algar, Jonathan Anderson, David Austin, David Baker, Kathy Blavius, Mark Bloch, Michael Boyle, David Bradford, Leah Carrall, Andrew Carr, John Chuah, Michael Curry, Clive D'Arcy-Evans, Pauline Dobson, Nicholas Doong, Wendy Ferguson, Robert Finlayson, Martyn French, Julian Gold, Philip Habel, Jennifer Hoy, Jeff Hudson, Robyn James, Sarangapany Jeganathan, Jenny Leung, Kaye Lowe, Karen MacRae, Simon Mallal, Marilyn McMurchie, Nicholas Medland, Anne Mijch, Samantha Miller, Jo Murray, David Orth, Julie Patching, Ruth Primrose, Dick Quan, Michael Rawlinson, Hugo Ree, Robyn Richardson, Gary Rogers, Janine Roney, Norman Roth, David Shaw, Tuck Meng Soo, David Sowden, Alison Street, Alan Street, Robyn Vale

Research output: Contribution to journalArticlepeer-review

5 Scopus citations

Abstract

Background: ESPRIT, is a phase III, open-label, randomized, international clinical trial evaluating the effects of subcutaneous recombinant interleukin-2 (rIL-2) plus antiretroviral therapy (ART) versus ART alone on HIV-disease progression and death in HIV-1-infected individuals with CD4+ T-cells ≥300 cells/μL. Objectives: To describe the baseline characteristics of participants randomized to ESPRIT overall and by geographic location. Method: Baseli ne characteristics of randomized participants were summarized by region. Results: 4,150 patients were enrolled in ESPRIT from 254 sites in 25 countries. 41%, 27%, 16%, 11%, and 5% were enrolled in Europe, North America, South America, Asia, and Australia, respectively. The median age was 40 years, 81% were men, and 76%, 11%, and 9% were Caucasian, Asian, and African American or African, respectively. 44% of women enrolled (n = 769) were enrolled in Thailand and Argentina. Overall, 55% and 38% of the cohort acquired HIV through male homosexual and heterosexual contact, respectively. 25% had a prior history of AIDS-defining illness; Pneumocystis jirovecii pneumonia, M. tuberculosis, and esophageal candida were most commonly reported. Median nadir and baseline CD4+ T-cell counts were 199 and 458 cells/μL, respectively. 6% and 13% were hepatitis B or C virus coinfected, respectively. Median duration of antiretroviral therapy (ART) was 4.2 years; the longest median duration was in Australia (5.2 years) and the shortest was in Asia (2.3 years). 17%, 13%, and 69% of participants began ART before 1995, between 1996 and 1997, and from 1998 onward, respectively. 86% used ART from two or more ART classes, with 49% using a protease inhibitor-based regimen and 46% using a nonnucleoside reverse transcriptase inhibitor-based regimen. 78% had plasma HIV RNA below detection (<500 cp/mL). Conclusion: ESPRIT has enrolled a diverse population of HIV-infected individuals including large populations of women and patients of African-American/African and Asian ethnicity often underrepresented in HIV research. As a consequence, the results of the study may have wide global applicability.

Original languageEnglish (US)
Pages (from-to)70-85
Number of pages16
JournalHIV Clinical Trials
Volume7
Issue number2
DOIs
StatePublished - Mar 2006

Keywords

  • AIDS-defining illness
  • ESPRIT
  • HIV
  • Proression of disease
  • Recombinant interleukin-2

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