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Blood, 1 May 2004, Vol. 103, No. 9, pp. 3282-3286.
Prepublished online as a Blood First Edition Paper on January 15, 2004; DOI 10.1182/blood-2003-09-3283.


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CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS

Induction and maintenance therapy with intermittent interleukin-2 in HIV-1 infection

Claire E. Farel, Doreen G. Chaitt, Barbara K. Hahn, Jorge A. Tavel, Joseph A. Kovacs, Michael A. Polis, Henry Masur, Dean A. Follmann, H. Clifford Lane, and Richard T. Davey, Jr

From the Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH); and the Critical Care Medicine Department, The Warren G. Magnuson Clinical Center, NIH, Department of Health and Human Services, Bethesda, MD.

Studies establishing that intermittent subcutaneous interleukin-2 (IL-2) therapy can lead to substantial CD4 cell increases in many HIV-infected patients have generally been of limited duration. We studied 77 patients participating in active longitudinal studies of subcutaneous IL-2 therapy at our center in order to determine the long-term feasibility of this approach. Following initial induction, patients in each trial were eligible to receive intermittent 5-day cycles of subcutaneous IL-2 treatment at individualized doses and frequencies capable of maintaining CD4 counts at postinduction levels. The mean duration of study participation to date is 5.9 years (range, 1.0-9.3 years). Mean baseline CD4 cell count and CD4 percent values of 0.521 x 109/L (521 cells/µL) and 27% have risen to 1.005 x 109/L (1005 cells/µL) and 38%, respectively, at 90 months. The mean number of subcutaneous IL-2 cycles required to achieve and maintain these increases was 10 cycles (range, 3-29 cycles), and the current mean interval of cycling required to maintain these elevations is 39 months (median, 35 months; range, 2-91 months). We conclude that subcutaneous IL-2 therapy is capable of maintaining CD4 cell increases for an extended period using a remarkably low frequency of intermittent cycling. These observations may contribute to patients' acceptance of subcutaneous IL-2 as a favorable long-term treatment strategy. (Blood. 2004;103:3282-3286)


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