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A randomized, double-blinded, placebo-controlled trial of intermittent administration of interleukin-2 and prednisone in subjects infected with human immunodeficiency virus

  1. Author:
    Tavel, J. A.
    Sereti, I.
    Walker, R. E.
    Hahn, B.
    Kovacs, J. A.
    Jagannatha, S.
    Davey, R. T.
    Falloon, J.
    Polis, M. A.
    Masur, H.
    Metcalf, J. A.
    Stevens, R.
    Rupert, A.
    Baseler, M.
    Lane, H. C.

  2. Author Address

    NIAID, Off Clin Director, NIH, 9000 Rockville Pike,Rm 11C103, Bethesda, MD 20892 USA NIAID, Off Clin Director, NIH, Bethesda, MD 20892 USA NIH, Immunoregulat Lab, Bethesda, MD 20892 USA NIH, Dept Crit Care Med, Ctr Clin, Bethesda, MD 20892 USA Sci Applicat Int Corp, Frederick, MD USA Tavel JA NIAID, Off Clin Director, NIH, 9000 Rockville Pike,Rm 11C103, Bethesda, MD 20892 USA
    1. Year: 2003
  2. Journal: Journal of Infectious Diseases
    1. 188
    2. 4
    3. Pages: 531-536
  4. Type of Article: Article
  1. Abstract:

    Intermittent administration of interleukin (IL)-2 produces significant and sustained increases in CD4(+) T lymphocyte count in human immunodeficiency virus (HIV)-infected subjects but can be associated with dose-limiting toxicities. The primary objective of this study was to determine whether concomitant administration of prednisone could decrease these toxicities. HIV-seropositive adults receiving highly active antiretroviral therapy (HAART) were randomized to receive either (1) intermittent subcutaneous IL-2 and placebo, (2) intermittent subcutaneous IL-2 and prednisone, (3) intermittent prednisone, or (4) intermittent placebo. Prednisone decreased levels of proinflammatory cytokines during IL-2 cycles but, despite induction of expression of CD25, blunted increases in IL-2-associated CD4(+) T lymphocyte count. Whereas intermittent administration of IL-2 reduced basal proliferation of CD4(+) T cells, this effect was inhibited by prednisone, suggesting that prednisone potentially interferes with IL-2's long-term effects on survival of T lymphocytes.

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