A randomized trial of high- versus low-dose subcutaneous interleukin-2 outpatient therapy for early human immunodeficiency virus type 1 infection

Forty-nine outpatients infected with human immunodeficiency virus with base line CD4 cell counts greater than or equal to 500/mm(3), who were on stable antiretroviral therapy, were randomized to receive 5-day cycles of either low-dose (1.5 million IU [MIU] twice a day) or high-dose (7.5 MIU twice a d ay) subcutaneous (sc) interleukin (IL)-2 every 4 or every 8 weeks. High-dos e recipients experienced mean slopes of +116.1 cells/month and +2.7%/month in CD4 cells and percents, respectively, whereas low-dose recipients displa yed mean slopes of +26.7 and +1.3% in the same parameters. At month 6, high -dose recipients achieved a 94.8% increase in mean CD4 cells over baseline compared with a 19.0% increase in low-dose recipients, While high-dose reci pients encountered more constitutional side effects, these were generally n ot dose-limiting. High-dose scIL-2 therapy in outpatients with early HIV-1 infection was well tolerated and induced dramatic, sustained rises in CD4 c ells.