This study is undertaken to evaluate the toxicity and obtain preliminary evidence of the efficacy of the combination of ziduvodine and interleukin 2 in the treatment of HIV infection. This study is designed as a dose escalation study. Groups of three to five patients are enrolled on a given dose of IL-2 starting at a .25 million units per day. The IL-2 is administered for three weeks by continuous infusion. The goal of this study is to determine the maximum tolerated dose of the combination of IL-2 and AZT. To date, 23 patients have enrolled in the study, receiving up to 4 million units of IL-2 per day. Toxicities that have been seen to date include renal dysfunction, respiratory distress, hepatitis, and severe myelgias/fatigue. Immunostimulatory effects of IL-2 have been seen at doses above l million units/d, and have included increases in CD4 counts, natural killer cell activity, lymphokine-activated killer cell (LAK cell) number and LAK cell activity. Responses to date appear to be temporary, however, and have largely disappeared by one month after discontinuation of IL-2. Current plans are to treat a small number of patients with IL-2 administered for 5 days every 2 months for 1 year, to determine the long- term toxicible and potential benefit of IL-2 in HIV-infected patients. The importance of this study is that it assesses a combination of an antiviral drug and an immunostimulatory drug in one of the first trials of its kind in the U.S.
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