Thirty human immunodeficiency virus (HIV)-infected patients with CD4(+) T cell counts <350 cells/mm(3) who had received stable, highly active antiretroviral therapy (HAART) for at least 24 weeks were randomized to receive either placebo or granulocyte colony-stimulating factor (G-CSF; 0.3 mg/mL 3 times a week) for 12 weeks. Blood samples were collected at specified time points. G-CSF treatment enhanced the total lymphocyte count (P = .002) and increased CD3(+) (P = .005), CD4(+) (P = .03), and CD8(+) (P = .004) T cell counts as well as numbers of CD3(-)CD16(+)CD56(+) NK cells (P = .001). The increases in CD4(+) and CD8(+) cell counts resulted from increases in CD45RO(+) memory T cells and cells expressing the CD38 activation marker. Lymphocyte proliferative responses to phytohemagglutinin and Candida antigen decreased, whereas NK cell activity and plasma HIV RNA did not change during G-CSF treatment. After 24 weeks, all immune parameters had returned to baseline 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.
