Interleukin-2 Plus Antiretroviral Therapy for HIV-Infected Patients With Low CD4+ Counts (SILCAAT Study)

The purpose of this study is to compare the clinical results of individuals living with advanced HIV infection who are treated with interleukin-2 (IL-2) plus active antiretroviral therapy (ART) to a control group of individuals treated with stable ART alone. The primary objective of the study is to determine if intermittent cycles of IL-2 delay the occurrence of opportunistic infections and the progression of advanced HIV disease compared to ART alone. Patients will be assigned randomly to 1 of 2 groups. Patients in Group 1 will receive subcutaneous IL-2 twice a day for 5 days, every 8 weeks, in addition to ART. Patients in Group 2 will receive ART only. In both groups, CD4+ T cell counts and viral load are monitored.