Jacobson Jeffrey M, Lederman Michael M, Spritzler John, Valdez Hernan, Tebas Pablo, Skowron Gail, Wang Rui, Jackson J Brooks, Fox Lawrence, Landay Alan, Gilbert Mark J, O'Neil Dorothy, Bancroft Lynne, Al-Harthi Lena, Jacobson Mark A, Merigan Thomas C, Glesby Marshall J
Department of Medicine, Beth Israel Medical Center and Albert Einstein College of Medicine, New York, New York 10003, USA.
J Infect Dis. 2003 Dec 15;188(12):1804-14. doi: 10.1086/379899. Epub 2003 Dec 9.
Studies have reported that plasma human immunodeficiency virus type 1 (HIV-1) RNA levels and CD4+ lymphocyte counts in HIV-infected patients improved after treatment with granulocyte-macrophage colony-stimulating factor (GM-CSF).
In AIDS Clinical Trials Group Protocol 5041, 116 patients were enrolled in a double-blind, randomized, placebo-controlled clinical trial of 16 weeks of 250 microg of GM-CSF administered subcutaneously 3 times/week, followed by open-label treatment for an additional 32 weeks. Patients had stable baseline plasma HIV-1 RNA levels of > or =1500 copies/mL and received constant antiretroviral regimens through at least the first 16 weeks of the study.
After 16 weeks, the GM-CSF group tended to have greater, though clinically insignificant, increases in plasma HIV-1 RNA levels, compared with the placebo group (median change, +0.048 vs. -0.103 log copies/mL; P=.036, in a post hoc analysis). There were trends toward progressive modest increases in CD4+ lymphocyte counts with GM-CSF treatment at 16 weeks (median change, +14 vs. -6 cells/mm3; P=.06) and beyond.
GM-CSF does not have an antiviral effect in patients with ongoing HIV replication but may increase CD4+ lymphocyte counts.
