Efficacy of low-dose intermittent subcutaneous interleukin (IL)-2 in antiviral drug-experienced human immunodeficiency virus-infected persons with detectable virus load: A controlled study of 3 IL-2 regimens with antiviral drug therapy

To evaluate the safety and efficacy of 3 regimens of intermittent subcutane ous (sc) interleukin (IL)-2 in a phase 2 study, 61 antiviral drug-experienc ed human immunodeficiency virus (HIV)-positive patients were randomly assig ned to one of the following study arms: antiretroviral therapy (ART) plus I L-2 (12 million IU [MIU] by continuous intravenous infusion, followed by 7. 5 MIU twice a day, sc, every 8 weeks); ART plus IL-2 (7.5 MIU twice a day, sc, every 8 weeks); ART plus IL-2 (3 MIU twice a day, sc, every 4 weeks); o r ART alone. A significant increase of circulating CD4 cells was observed i n IL-2-treated subjects, compared with those given ART alone. Low doses of IL-2 were better tolerated. Despite the incomplete suppression of viral rep lication, IL-2 with ART did not increase either plasma viremia or cell-asso ciated HIV DNA levels. Low doses of intermittent sc IL-2 induced a stable i ncrease of peripheral CD4 cells that was indistinguishable from those assoc iated with higher, less well-tolerated doses of IL-2.