Background
A recent study of low dose IL-2 administered for 6 months in patients with CD4 counts between 200-500 demonstrated improvement in delayed-type hypersensitivity responses and CD4 counts without increases in HIV viral load. Low dose IL-2 was well tolerated without persistent side effects.

Objective
To determine the safety and efficacy of daily subcutaneous administration of low dose IL-2 in patients with CD4 count below 200.

Study Design
This is a study of HIV+ patients with T-cells <200 and HIV RNA <500. Patients will be randomized (1:1) to either 1) continued HAART therapy or 2) current therapy plus low dose IL-2 (1.2 MU) administered SQ daily for 6 months. All study drug and laboratory tests will be provided at no charge. All patients completing the 6 month study period will be eligible to receive open label IL-2 during a 6 month extension phase.

Inclusion Criteria
1) HIV seropositive with T-cells <200 and HIV RNA <500
2) Stable HAART therapy for at least 2 months prior to enrollment
3) Prior use of IL-2 or recent use of any immunomodulatory
therapy excluded.

For more information please contact Dr. Jacob Lalezari of Quest Clinical Research at (415) 353-0800