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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-five persons with &lt;/=250 CD4 cells/microL and plasma HIV-1 RNA levels &lt;/=500 copies/mL for &gt;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 (n=12). The level of CD4 T cells was significantly higher in the IL-2 group at week 24 (105+/-65/microL; P&lt;.05) but not in the control group (30+/-78/microL). Memory T cells initially contributed to the CD4 T cell increase at week 4 (P&lt;.05). Naive T cell increases (99+/-58/microL) in the IL-2 group became statistically significant at week 24 compared with the control group (28+/-27/microL; P&lt;.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.

the journal of infectious diseases (online. university of chicago press)/the journal of infectious diseases

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