Efficacy of low-dose subcutaneous interleukin-2 to treat advanced human immunodeficiency virus type 1 in persons with ≤250/μL CD4 T cells and undetectable plasma virus load

The immunologic efficacy of low;dose recombinant interleukin-2 (rIL-2) administered subcutaneously (sc) once a day in combination with highly active antiretroviral therapy (HAART) was assessed in a pilot study in patients with advanced human immunodeficiency virus HIV disease. Twenty-live persons with less than or equal to 250 CD4 cells/mu L and plasma HIV-1 RNA levels less than or equal to 500 copies/mL for >24 weeks were randomly assigned to receive sc rIL-2 (3 X 10(6) IU once a day) with their previous antiretroviral regimen (n = 13) or to continue with the same treatment (PE = 12), The level of CD4 T cells was significantly higher in the IL-2 group at week 24 (105 +/- 65/mu L; P<.05) but not in the control group (30 +/- 78/mu L), Memory T cells initially contributed to the CD4 T cell increase at week 4 (P<.05), Naive T cell increases (99 +/- 58/mu L) in the IL-2 group became statistically significant at week 24 compared with the control group (28 +/- 27/mu L; P<.05). Subcutaneous rIL-2 once a day in combination with HAART was well tolerated and improved immunologic surface markers in patients with advanced HIV infection.