CPCRA 059:IMPACT OF 2 DOSES OF SUBCUTANEOUS RECOMBINANT IL 2 ON VIRAL

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This is a randomized open-label trial study to compare the effects of two doses of subcutaneous (SC) recombinant IL-2 (rIL-2) and no rIL-2 on HIV viral burden and CD4+ cell count in patients with HIV-1 infection and absolute CD4 cell counts of > 350/mm3. Study participants will be either currently receiving or initiating antiretroviral treatment prior to randomization. If the international phase III clinical endpoint trial of SC rIL-2 is implemented, patients enrolled in this CPCRA study will be strongly encouraged to enroll and receive continued treatment and follow-up in the international study. The total sample size is 460 patients. Two hundred and thirty patients will randomized to one of two doses of SC rIL-2 therapy (4.5 MIU or 7.5 MIU twice daily), and 230 patients will be randomized to no SC rIL-2 over an anticipated enrollment period of 12 months.