title: Phase II controlled trial of post-exposure immunization with recombinant gp160 versus antiretroviral therapy in asymptomatic HIV-1-infected adults. VaxSyn Protocol Team.
abstract: OBJECTIVE
  To alter the natural course of HIV-1 infection by inducing or potentiating immune responses to HIV-1 envelope glycoprotein.
  
  
  METHODS
  Multicentre, double-blind, three-arm, placebo-controlled study.
  
  
  METHODS
  Outpatients attending clinics in two University Hospitals.
  
  
  METHODS
  Ninety-nine asymptomatic HIV-1-infected adults with CD4+ T-cell counts > 400 and < 600 x 10(6)/l and no previous antiretroviral therapy were included.
  
  
  METHODS
  Patients were randomly assigned to three groups treated with: (i) gp160 in alum over a 2-year period in combination with placebo for the full study duration (n = 32); (ii) gp160 in alum over a 2-year period in combination with zidovudine for the full study duration (n = 34); and (iii) alum over a 2-year period in combination with zidovudine for the full study duration (n = 33).
  
  
  RESULTS
  Immunotherapy was well tolerated and no significant differences in disease progression were seen in the treatment groups. The majority of patients (85%) receiving gp160 showed persistent lymphoproliferative responses to the immunogen and to a different Env antigen preparation. CD4+ cell count changes in patients receiving zidovudine alone were significantly higher than those seen in patients receiving immunotherapy alone after 1 year of treatment. Zidovudine administration was associated with initial transient reduction of plasma viraemia.
  
  
  CONCLUSIONS
  Prolonged immunization with a soluble HIV-1 subunit provided no benefit to asymptomatic HIV-1-infected patients and was inferior to zidovudine monotherapy. Furthermore, immunization with gp160 shortened the duration of the transient viral load reduction induced by zidovudine.
authors.affiliation: Department of Clinical Medicine, University of Rome La Sapienza, Italy.
authors.forename: O
authors.initials: O
authors.lastname: Pontesilli
authors.forename: E C
authors.initials: EC
authors.lastname: Guerra
authors.forename: A
authors.initials: A
authors.lastname: Ammassari
authors.forename: C
authors.initials: C
authors.lastname: Tomino
authors.forename: M
authors.initials: M
authors.lastname: Carlesimo
authors.forename: A
authors.initials: A
authors.lastname: Antinori
authors.forename: E
authors.initials: E
authors.lastname: Tamburrini
authors.forename: A
authors.initials: A
authors.lastname: Prozzo
authors.forename: A C
authors.initials: AC
authors.lastname: Seeber
authors.forename: S
authors.initials: S
authors.lastname: Vella
authors.forename: L
authors.initials: L
authors.lastname: Ortona
authors.forename: F
authors.initials: F
authors.lastname: Aiuti
mesh_terms: D016915:AIDS Vaccines / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D018791:CD4 Lymphocyte Count; D018414:CD8-Positive T-Lymphocytes; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005260:Female; D019302:HIV Envelope Protein gp160 / Q000276:immunology*; D015658:HIV Infections / Q000188:drug therapy / Q000276:immunology / Q000628:therapy* / Q000821:virology; D015497:HIV-1 / Q000187:drug effects; D006801:Humans; D008214:Lymphocytes / Q000276:immunology; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000097:blood; D013997:Time Factors; D014614:Vaccines, Synthetic / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D014766:Viremia; D015215:Zidovudine / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D016915:AIDS Vaccines; D019302:HIV Envelope Protein gp160; D012367:RNA, Viral; D014614:Vaccines, Synthetic; C053473:VaxSyn HIV-1 (gp160) vaccine; D015215:Zidovudine