Immunological and virological changes in antiretroviral naive human immunodeficiency virus infected patients randomized to G-CSF or placebo simultaneously with initiation of HAART

To determine the efficacy of combined G-CSF and highly active antiretrovira l treatment (HAART), a randomized, double blind, placebo controlled study w as conducted. Treatment naive human immunodeficiency virus (HIV) infected p atients were randomized to receive either placebo or G-CSF (0.3 mg/ml, 3 ti mes a week) for 12 weeks and HAART simultaneously. The trial was terminated prematurely after interim analysis performed because of a case of severe e ncephalopathia in the G-CSF group. At that point 11 HIV infected patients w ith a CD4(+) T cell count < 350/mm(3) had been randomized to the G-CSF grou p (n = 6) or placebo group (n = 5). In both groups plasma HIV RNA decreased significantly in response to HAART. However, plasma HIV RNA changed signif icantly different between the two groups with the decrease being less prono unced in the G-CSF group (P = 0.02). The concentrations of CD4(+) memory T cells and CD8(+) naive and memory T cells increased in response to HAART, a nd there was a trend towards more pronounced increases in several T-cell su bpopulations in the G-CSF group. The CD56(+) NK cells increased significant ly more in the G-CSF group compared with placebo (P = 0.000). All patients in the G-CSF group reported bone pain. The present data do not support simu ltaneous administration of G-CSF with initiation of HAART in treatment naiv e HIV infected patients.