Granulocyte colony-stimulating factor increases CD4(+) T cell counts of human immunodeficiency virus-infected patients receiving stable, highly active antiretroviral therapy: Results from a randomized, placebo-controlled trial

Thirty human immunodeficiency virus (HIV)-infected patients with CD4(+) T c ell counts <350 cells/mm(3) who had received stable, highly active antiretr oviral therapy (HAART) for at least 24 weeks were randomized to receive eit her placebo or granulocyte colony-stimulating factor (G-CSF; 0.3 mg/mL 3 ti mes a week) for 12 weeks. Blood samples were collected at specified time po ints. G-CSF treatment enhanced the total lymphocyte count (P = .002) and in creased CD3(+) (P = .005), CD4(+) (P = .03), and CD8(+) (P = .004) T cell c ounts as well as numbers of CD3(-)CD16(+)CD56(+) NK cells (P = .001). The i ncreases in CD4(+) and CD8(+) cell counts resulted from increases in CD45RO (+) memory T cells and cells expressing the CD38 activation marker. Lymphoc yte proliferative responses to phytohemagglutinin and Candida antigen decre ased, whereas NK cell activity and plasma HIV RNA did not change during G-C SF treatment. After 24 weeks, all immune parameters had returned to baselin e values. This study suggests that G-CSF treatment of HIV-infected patients receiving stable HAART increases the concentration of CD4(+), CD8(+), and NK cells without inducing changes in the virus load.