This study is undertaken to evaluate the toxicity and obtain preliminary evidence of the efficacy of the combination of zidovudine and interleukin-2 in the treatment of HIV infection. This study was initially designed as a dose escalation study. In this phase of the study, it was determined that 2.0 million units, given by continuous infusion over a 24 hour period is the maximum tolerated dose that can be given for 21 days. Additionally, 3 million units can be tolerated when administered for only 5 days. We have proceeded to the next phase of the study which is to administer repeat courses of interleukin-2 to six patients over the course of a year. Interleukin-2, at a dose of 3 million units has been administered by continuous infusion for 5 days every two months. Patients are seen monthly and will have immunologic and virologic evaluation done at those times. They require hospitalization every two months for the administration of interleukin-2. The repeat courses have been well tolerated to date, although 3 of the 5 patients have required dosage reductions. One patient has completed the one year treatment period and is in a follow-up evaluation. Immunostimulatory effects of IL-2 have been seen immediately following completion of the IL-2 infusion but have largely disappeared by the one month follow-up evaluation. The completion of the one year courses for all patients enrolled will provide information about the tolerance of such a regimen and also should provide some preliminary information about the long-term immunostimulatory effects of such repeat courses of IL-2. The importance of this study is that it is a combination of an antiretroviral drug and an immunostimulatory drug in one of the first trials of its kind in United States.
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