OUTPATIENT CONTINUOUS INTRAVENOUS INTERLEUKIN-2 OR SUBCUTANEOUS, POLYETHYLENE GLYCOL-MODIFIED INTERLEUKIN-2 IN HUMAN IMMUNODEFICIENCY VIRUS-INFECTED PATIENTS - A RANDOMIZED, CONTROLLED, MULTICENTER STUDY

The safely and activity of outpatient-based continuous intravenous int erleukin-2 (CIV IL-2) or a slow-release, polyethylene glycol (PEG)-mod ified IL-2 were studied in human immunodeficiency virus (HIV)-infected persons with CD4 cell counts between 200 and 500/mm(3). One hundred f ifteen patients were randomized to antiretroviral therapy plus cyclica l CIV IL-2 (n = 27), subcutaneous PEG IL-2 (n = 58), or no IL-2 (n = 3 0). Toxicity withdrawal rates were low (4% for CIV IL-2 and 7% for PEG IL-2), There were median CD4 cell count increases of 359 and 44 cells /mm(3) and a decline of 46 cells/mm(3) in the 3 groups, respectively, over 1 year (P < .0001 for each intergroup comparison). CD4 cell count increases were greatest in those with lower HIV RNA load, Delayed-typ e hypersensitivity scores increased and HLA-DR expression on CD8 cells decreased significantly with IL-2 therapy. HIV RNA levels were unaffe cted. IL-2 therapy may expand the existing immune repertoire but not i mmediately reconstitute lost immune function.