title: Immunological and virological changes in antiretroviral naïve human immunodeficiency virus infected patients randomized to G-CSF or placebo simultaneously with initiation of HAART.
abstract: To determine the efficacy of combined G-CSF and highly active antiretroviral treatment (HAART), a randomized, double blind, placebo controlled study was conducted. Treatment naive human immunodeficiency virus (HIV) infected patients were randomized to receive either placebo or G-CSF (0.3 mg/ml, 3 times a week) for 12 weeks and HAART simultaneously. The trial was terminated prematurely after interim analysis performed because of a case of severe encephalopathia in the G-CSF group. At that point 11 HIV infected patients with a CD4+ T cell count < 350/mm3 had been randomized to the G-CSF group (n = 6) or placebo group (n = 5). In both groups plasma HIV RNA decreased significantly in response to HAART. However, plasma HIV RNA changed significantly different between the two groups with the decrease being less pronounced 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, and there was a trend towards more pronounced increases in several T-cell subpopulations in the G-CSF group. The CD56+ NK cells increased significantly 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 simultaneous administration of G-CSF with initiation of HAART in treatment naive HIV infected patients.
authors.affiliation: Departments of Infectious Diseases, Copenhagen University Hospital (Rigshopitalet), M7641, Tagensvej 20, 2200 Copenhagen N, Denmark.
authors.forename: H
authors.initials: H
authors.lastname: Aladdin
authors.forename: H
authors.initials: H
authors.lastname: Ullum
authors.forename: T
authors.initials: T
authors.lastname: Katzenstein
authors.forename: J
authors.initials: J
authors.lastname: Gerstoft
authors.forename: P
authors.initials: P
authors.lastname: Skinhøj
authors.forename: B
authors.initials: B
authors.lastname: Klarlund Pedersen
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage / Q000627:therapeutic use*; D015658:HIV Infections / Q000097:blood / Q000276:immunology* / Q000503:physiopathology / Q000821:virology*; D015497:HIV-1 / Q000235:genetics; D006801:Humans; D007694:Killer Cells, Natural / Q000166:cytology; D008214:Lymphocytes / Q000166:cytology; D008875:Middle Aged; D009504:Neutrophils / Q000166:cytology; D012367:RNA, Viral / Q000097:blood
chemical_list: D012367:RNA, Viral; D016179:Granulocyte Colony-Stimulating Factor