A randomized, controlled, phase II trial comparing escalating doses of subcutaneous interleukin-2 plus antiretrovirals versus antiretrovirals alone in human immunodeficiency virus-infected patients with CD4(+) cell counts >=350/mm(3)

A total of 73 patients with baseline CD4(+) cell counts greater than or equ al to 350 cells/mm(3) who were receiving combination antiretroviral therapy (ART) were randomized to receive subcutaneous interleukin-2 (IL-2; n = 36) in addition to ART or to continue ART alone (n = 37), Subcutaneous IL-2 wa s delivered at 1 of 3 doses (1.5 million international units [MIU], 4.5 MIU , and 7.5 MIU per dose) by twice-daily injection for 5 consecutive days eve ry 8 weeks. After 24 weeks, the time-weighted mean change from baseline CD4 (+) cell count was 210 cells/mm(3) for recipients of subcutaneous IL-2, com pared with 29 cells/mm(3) for recipients of ART alone (P < .001). There wer e no significant differences between treatment groups for measures of plasm a human immunodeficiency virus RNA (P = .851). Subcutaneous IL-2 delivered at doses of 4.5 MIU and 7.5 MIU resulted in significant increases in CD4(+) cell count (P = .006 and P < .001, respectively), compared with that seen in control patients. These changes were not significant in the 1.5 MIU dose group compared with that in the control patients (P = .105). Side effects that occurred from subcutaneous IL-2 administration were generally low grad e, of short duration, and readily managed in an outpatient environment.