Granulocyte-Macrophage Colony-Stimulating Factor Induces Modest Increases in Plasma Human Immunodeficiency Virus (HIV) Type 1 RNA Levels and CD4+ Lymphocyte Counts in Patients with Uncontrolled HIV Infection

• Published in: The Journal of infectious diseases 2003-12, Vol.188 (12), p.1804-1814
• Main Authors: 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.
• Format: Article
• Language: English
• Subjects: Adult; AIDS; Antiretrovirals; Biological and medical sciences; Blood plasma; CD4 Lymphocyte Count; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes - immunology; CD8-Positive T-Lymphocytes - immunology; Colony stimulating factors; Double-Blind Method; Female; Fundamental and applied biological sciences. Psychology; Granulocyte-Macrophage Colony-Stimulating Factor - adverse effects; Granulocyte-Macrophage Colony-Stimulating Factor - therapeutic use; HIV; HIV 1; HIV Infections - blood; HIV Infections - drug therapy; HIV Infections - immunology; HIV-1 - isolation & purification; HIV/AIDS; Human viral diseases; Humans; Infectious diseases; Injections, Subcutaneous; Lymphocytes; Male; Medical sciences; Microbiology; Miscellaneous; Placebos; RNA; RNA, Viral - blood; T lymphocytes; United States; Viral diseases; Viral diseases of the lymphoid tissue and the blood. Aids; Virology
• ISSN: 0022-1899; 1537-6613
• DOI: 10.1086/379899

BackgroundStudies 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) MethodsIn AIDS Clinical Trials Group Protocol 5041, 116 patients were enrolled in a double-blind, randomized, placebo-controlled clinical trial of 16 weeks of 250 μg 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 ⩾1500 copies/mL and received constant antiretroviral regimens through at least the first 16 weeks of the study ResultsAfter 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 ConclusionsGM-CSF does not have an antiviral effect in patients with ongoing HIV replication but may increase CD4+ lymphocyte counts