Efficacy of low-dose intermittent subcutaneous interleukin (IL)-2 in antiviral drug-experienced human immunodeficiency virus-infected persons with detectable virus load: A controlled study of 3 IL-2 regimens with antiviral drug therapy

G. Tambussi, S. Ghezzi, S. Nozza, G. Vallanti, L. Magenta, M. Guffanti, A. Brambilla, E. Vicenzi, P. Carrera, S. Racca, L. Soldini, N. Gianotti, M. Murone, F. Veglia, G. Poli, A. Lazzarin

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To evaluate the safety and efficacy of 3 regimens of intermittent subcutaneous (sc) interleukin (IL)-2 in a phase 2 study, 61 antiviral drug-experienced human immunodeficiency virus (HIV)-positive patients were randomly assigned to one of the following study arms: Antiretroviral therapy (ART) plus IL-2 (12 million IU [MIU] by continuous intravenous infusion, followed by 7.5 MIU twice a day, sc, every 8 weeks); ART plus IL-2 (7.5 MIU twice a day, sc, every 8 weeks); ART plus IL-2 (3 MIU twice a day, sc, every 4 weeks); or ART alone. A significant increase of circulating CD4 cells was observed in IL-2-treated subjects, compared with those given ART alone. Low doses of IL-2 were better tolerated. Despite the incomplete suppression of viral replication, IL-2 with ART did not increase either plasma viremia or cell-associated HIV DNA levels. Low doses of intermittent sc IL-2 induced a stable increase of peripheral CD4 cells that was indistinguishable from those associated with higher, less well-tolerated doses of IL-2.

Original languageEnglish
Pages (from-to)1476-1484
Number of pages9
JournalJournal of Infectious Diseases
Issue number10
Publication statusPublished - May 15 2001


ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health
  • Immunology

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