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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.

Author(s): Jacobson JM, Lederman MM, Spritzler J, Valdez H, Tebas P, Skowron G, Wang R, Jackson JB, Fox L, Landay A, Gilbert MJ, O'Neil D, Bancroft L, Al-Harthi L, Jacobson MA, Merigan TC Jr, Glesby MJ, National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group

Affiliation(s): Department of Medicine, Beth Israel Medical Center and Albert Einstein College of Medicine, New York, New York 10003, USA. jjacobson@chpnet.org

Publication date & source: 2003-12-15, J Infect Dis., 188(12):1804-14. Epub 2003 Dec 9.

Publication type: Clinical Trial; Randomized Controlled Trial

BACKGROUND: 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). METHODS: 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. RESULTS: 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. CONCLUSIONS: GM-CSF does not have an antiviral effect in patients with ongoing HIV replication but may increase CD4+ lymphocyte counts.

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