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A randomized trial of high- versus low-dose subcutaneous interleukin-2 outpatient therapy for early human immunodeficiency virus type 1 infection

  1. Author:
    Davey, R. T.
    Chaitt, D. G.
    Albert, J. M.
    Piscitelli, S. C.
    Kovacs, J. A.
    Walker, R. E.
    Falloon, J.
    Polis, M. A.
    Metcalf, J. A.
    Masur, H.
    Dewar, R.
    Baseler, M.
    Fyfe, G.
    Giedlin, M. A.
    Lane, H. C.

  2. Author Address

    Davey RT NIAID, Dept Crit Care Med, Warren G Magnuson Clin Ctr, NIH Bldg 10,Room 11C103 Bethesda, MD 20892 USA NIAID, Dept Crit Care Med, Warren G Magnuson Clin Ctr, NIH Bethesda, MD 20892 USA NIAID, Dept Pharm, Warren G Magnuson Clin Ctr, NIH Bethesda, MD 20892 USA Sci Applicat Int Corp Frederick, MD USA Chiron Corp Emeryville, CA 94608 USA
    1. Year: 1999
  2. Journal: Journal of Infectious Diseases
    1. 179
    2. 4
    3. Pages: 849-858
  4. Type of Article: Article
  1. Abstract:

    Forty-nine outpatients infected with human immunodeficiency virus with baseline CD4 cell counts greater than or equal to 500/mm(3), who were on stable antiretroviral therapy, were randomized to receive 5-day cycles of either low-dose (1.5 million IU [MIU] twice a day) or high-dose (7.5 MIU twice a day) subcutaneous (sc) interleukin (IL)-2 every 4 or every 8 weeks. High-dose recipients experienced mean slopes of +116.1 cells/month and +2.7%/month in CD4 cells and percents, respectively, whereas low-dose recipients displayed mean slopes of +26.7 and +1.3% in the same parameters. At month 6, high-dose recipients achieved a 94.8% increase in mean CD4 cells over baseline compared with a 19.0% increase in low-dose recipients, While high-dose recipients encountered more constitutional side effects, these were generally not dose-limiting. High-dose scIL-2 therapy in outpatients with early HIV-1 infection was well tolerated and induced dramatic, sustained rises in CD4 cells. [References: 17]

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