ACT 299--RECOMBINANT INTERLEUKIN 2 IN SYMPTOMATIC HIV INFECTED CHILDREN

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ACTG 299 is a two part, Phase I/II dose-escalating trial of recombinant interleukin-2 (rIL-2) in HIV-infected children ages 3-12 years old. The primary objective of Part A is to determine a safe and tolerated dose of rIL-2 in HIV-infected children. For Part B, the primary objective is to determine the safety of rIL-2 when given to a larger number of HIV-infected children at the dose tolerated by subjects in Part A. Secondary objectives are as follows: Part A: To determine the effect of various doses of rIL-2 on CD4 cell counts and to determine the effect of rIL-2 administration on viral load. Part B: To determine the effect of rIL-2 administration on a) antigen- and mitogen-induced lymphocyte proliferation and on cytotoxic T and NK cell responses; b) expression of HLA-DR and CD38 on CD4 and CD8 cells; c) viral load; d) CD4 cell counts; e) number of naive and memory CD4 and CD8 cells; e) apoptosis of peripheral blood mononuclear cells.