title: The effects of an HIV-1 immunogen (Remune) on viral load, CD4 cell counts and HIV-specific immunity in a double-blind, randomized, adjuvant-controlled subset study in HIV infected subjects regardless of concomitant antiviral drugs.
abstract: OBJECTIVE
  We examined the activity of an HIV-1 immunogen (Remune) on viral load, CD4 cells and HIV-1 specific immunity.
  
  
  METHODS
  Plasma and peripheral blood mononuclear cells were obtained in a predefined random subset of subjects (n = 252) from a multicentre, double-blind, adjuvant-controlled phase III clinical endpoint study.
  
  
  RESULTS
  The subjects treated with the HIV-1 immunogen had a significantly greater decline in viral load at multiple time points (P < 0.05), a trend towards increased CD4+ T cell counts and significantly enhanced HIV-1 specific immune responses as measured by HIV-1 lymphocyte proliferation (P < 0.001) compared to the adjuvant control group. Furthermore, in the HIV-1 immunogen treated group, enhanced HIV-1 specific lymphocyte proliferative immune responses were associated with decreased HIV-1 plasma RNA.
  
  
  CONCLUSIONS
  These results suggest that, in a predefined, random subset of subjects, a beneficial effect of the HIV-1 immunogen was observed on viral load, CD4+ T cells, and HIV-specific immunity. These differences were observed in a background of multiple drug therapies. Ongoing trials are evaluating the effect of the combination of this HIV-1 specific, immune-based therapy with potent antiviral drug therapy on virological outcomes.
authors.affiliation: The Graduate Hospital, Philadelphia, PA, USA.
authors.forename: J L
authors.initials: JL
authors.lastname: Turner
authors.forename: J R
authors.initials: JR
authors.lastname: Kostman
authors.forename: A
authors.initials: A
authors.lastname: Aquino
authors.forename: D
authors.initials: D
authors.lastname: Wright
authors.forename: S
authors.initials: S
authors.lastname: Szabo
authors.forename: R
authors.initials: R
authors.lastname: Bidwell
authors.forename: J
authors.initials: J
authors.lastname: Goodgame
authors.forename: A
authors.initials: A
authors.lastname: Daigle
authors.forename: E
authors.initials: E
authors.lastname: Kelley
authors.forename: F
authors.initials: F
authors.lastname: Jensen
authors.forename: C
authors.initials: C
authors.lastname: Duffy
authors.forename: D
authors.initials: D
authors.lastname: Carlo
authors.forename: R B
authors.initials: RB
authors.lastname: Moss
mesh_terms: D016915:AIDS Vaccines / Q000276:immunology / Q000494:pharmacology / Q000627:therapeutic use*; D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use; D018791:CD4 Lymphocyte Count; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D005620:Freund's Adjuvant / Q000627:therapeutic use; D015658:HIV Infections / Q000276:immunology* / Q000628:therapy*; D015497:HIV-1 / Q000235:genetics / Q000276:immunology*; D006801:Humans; D007111:Immunity, Cellular; D008297:Male; D012367:RNA, Viral / Q000097:blood; D013997:Time Factors; D019562:Viral Load
chemical_list: D016915:AIDS Vaccines; D000998:Antiviral Agents; D012367:RNA, Viral; C105086:remune; D005620:Freund's Adjuvant