Low-dose prolonged intermittent interleukin-2 adjuvant therapy: Results of a randomized trial among human immunodeficiency virus-positive patients with advanced immune impairment

Giulia Marchetti, Luca Meroni, Stefania Varchetta, Velislava Terzieva, Alessandra Bandera, Daniele Manganaro, Chiara Molteni, Daria Trabattoni, Sabrina Fossati, Mario Clerici, Massimo Galli, Mauro Moroni, Fabio Franzetti, Andrea Gori

Research output: Contribution to journalArticlepeer-review

Abstract

Twenty-two patients with CD4+cell counts ≤200 cells/μL after 12 months of stable highly active antiretroviral therapy (HAART; "immunologic nonresponders") were randomly assigned to receive subcutaneous low-dose prolonged intermittent interleukin (IL)-2 in addition to HAART (n = 12) or to continue HAART alone (n = 10). At 48 weeks of follow-up, no IL-2-related serious adverse events and no significant differences in plasma human immunodeficiency virus (HIV) RNA level were observed in the 2 groups. A higher incidence of HIV-related clinical events was observed among patients receiving HAART alone (3/10) than among subjects receiving HAART plus IL-2 (0/12). Significant increases in CD4+, naive, and CD4+CD7+ cells and plasma levels of IL-7 were observed in patients receiving IL-2 versus patients receiving HAART alone. A significant increase in cell turnover did not lead to a decrease in the frequency of T cell receptor excision circles, which remained stable. Rather, increased numbers of T cell receptor excision circles per microliter of blood were observed (not statistically significant). Thus, adjuvant IL-2 therapy in immunologic nonresponders resulted in a clinical benefit, suggesting that the quantitative cell recovery involves functionally competent immune cells.

Original languageEnglish
Pages (from-to)606-616
Number of pages11
JournalJournal of Infectious Diseases
Volume186
Issue number5
DOIs
Publication statusPublished - Sep 1 2002

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health
  • Immunology

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