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

The immunologic efficacy of low;dose recombinant interleukin-2 (rIL-2) admi nistered subcutaneously (sc) once a day in combination with highly active a ntiretroviral therapy (HAART) was assessed in a pilot study in patients wit h advanced human immunodeficiency virus HIV disease. Twenty-live persons wi th less than or equal to 250 CD4 cells/mu L and plasma HIV-1 RNA levels les s than or equal to 500 copies/mL for >24 weeks were randomly assigned to re ceive 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 lev el of CD4 T cells was significantly higher in the IL-2 group at week 24 (10 5 +/- 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 statisti cally 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 advanc ed HIV infection.