Outpatient continuous intravenous interleukin-2 or subcutaneous, polyethylene glycol-modified interleukin-2 in human immunodeficiency virus-infected patients: a randomized, controlled, multicenter study. Australian IL-2 Study Group

J Infect Dis. 1998 Oct;178(4):992-9. doi: 10.1086/515653.

Abstract

The safety and activity of outpatient-based continuous intravenous interleukin-2 (CIV IL-2) or a slow-release, polyethylene glycol (PEG)-modified IL-2 were studied in human immunodeficiency virus (HIV)-infected persons with CD4 cell counts between 200 and 500/mm3. One hundred fifteen patients were randomized to antiretroviral therapy plus cyclical CIV IL-2 (n = 27), subcutaneous PEG IL-2 (n = 58), or no IL-2 (n = 30). Toxicity withdrawal rates were low (4% for CIV IL-2 and 7% for PEG IL-2). There were median CD4 cell count increases of 359 and 44 cells/mm3 and a decline of 46 cells/mm3 in the 3 groups, respectively, over 1 year (P < .0001 for each intergroup comparison). CD4 cell count increases were greatest in those with lower HIV RNA load. Delayed-type hypersensitivity scores increased and HLA-DR expression on CD8 cells decreased significantly with IL-2 therapy. HIV RNA levels were unaffected. IL-2 therapy may expand the existing immune repertoire but not immediately reconstitute lost immune function.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Ambulatory Care*
  • CD4 Lymphocyte Count
  • Drug Administration Routes
  • Female
  • HIV Infections / drug therapy*
  • HIV Infections / immunology
  • Humans
  • Hypersensitivity, Delayed
  • Interleukin-2 / adverse effects
  • Interleukin-2 / analogs & derivatives*
  • Interleukin-2 / therapeutic use*
  • Male
  • Polyethylene Glycols
  • RNA, Viral / blood

Substances

  • Interleukin-2
  • RNA, Viral
  • interleukin-2, polyethylene glycol-modified
  • Polyethylene Glycols