title: 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.
abstract: 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.
authors.affiliation: Department of Medicine, Beth Israel Medical Center and Albert Einstein College of Medicine, New York, New York 10003, USA. jjacobson@chpnet.org
authors.forename: Jeffrey M
authors.initials: JM
authors.lastname: Jacobson
authors.forename: Michael M
authors.initials: MM
authors.lastname: Lederman
authors.forename: John
authors.initials: J
authors.lastname: Spritzler
authors.forename: Hernan
authors.initials: H
authors.lastname: Valdez
authors.forename: Pablo
authors.initials: P
authors.lastname: Tebas
authors.forename: Gail
authors.initials: G
authors.lastname: Skowron
authors.forename: Rui
authors.initials: R
authors.lastname: Wang
authors.forename: J Brooks
authors.initials: JB
authors.lastname: Jackson
authors.forename: Lawrence
authors.initials: L
authors.lastname: Fox
authors.forename: Alan
authors.initials: A
authors.lastname: Landay
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Gilbert
authors.forename: Dorothy
authors.initials: D
authors.lastname: O'Neil
authors.forename: Lynne
authors.initials: L
authors.lastname: Bancroft
authors.forename: Lena
authors.initials: L
authors.lastname: Al-Harthi
authors.forename: Mark A
authors.initials: MA
authors.lastname: Jacobson
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Merigan
authors.forename: Marshall J
authors.initials: MJ
authors.lastname: Glesby
mesh_terms: D000328:Adult; D018791:CD4 Lymphocyte Count; D016516:CD4-CD8 Ratio; D015496:CD4-Positive T-Lymphocytes / Q000276:immunology; D018414:CD8-Positive T-Lymphocytes / Q000276:immunology; D004311:Double-Blind Method; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000009:adverse effects / Q000627:therapeutic use*; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy* / Q000276:immunology*; D015497:HIV-1 / Q000302:isolation & purification*; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D012367:RNA, Viral / Q000097:blood*; D014481:United States
chemical_list: D012367:RNA, Viral; D016178:Granulocyte-Macrophage Colony-Stimulating Factor