title: Immunotherapy with canarypox vaccine and interleukin-2 for HIV-1 infection: termination of a randomized trial.
abstract: OBJECTIVE
  To determine whether immunotherapy of chronic HIV-1 infection can prevent or attenuate viremia upon antiviral discontinuation.
  
  
  METHODS
  This was a Phase II randomized, partially double blinded, 2x2 factorial study of three steps of 12 wk/step. Step I involved four groups: (1) vaccine placebo, (2) vaccine (ALVAC, vCP1452), (3) placebo + interleukin 2 (IL-2), and (4) vaccine + IL-2. Step II involved a 12-wk diagnostic treatment interruption (DTI). Step III involved an extension of the DTI for an additional 12 wk.
  
  
  METHODS
  The Weill-Cornell General Clinical Research Center.
  
  
  METHODS
  Chronically infected HIV-1 positive adults with undetectable HIV-1 levels and > 400 CD4+ T cells/microl.
  
  
  METHODS
  An HIV canarypox vaccine (vCP1452) and vaccine placebo, administered every 4 wk for four doses, and low-dose IL-2 administered daily for 12-24 wk.
  
  
  METHODS
  Primary endpoints: (1) Proportion of participants with undetectable plasma HIV RNA during trial Step II, (2) mean log10 HIV RNA copies/ml ([HIV]) from weeks 21-25, and (3) proportion of individuals eligible for trial Step III.
  
  
  RESULTS
  44 participants were randomized, but 16 withdrew or were withdrawn before completing Step II. As all participants underwent viral relapse in Step II, the study was terminated after 28 participants completed Step II. Among the four groups, there was no difference in mean [HIV] or the proportion of individuals with < log10 4.48 HIV; no difference between the mean [HIV] of the two groups that received ALVAC (n = 17) versus placebo (n = 11); and no significant difference between the mean [HIV] of the two groups that received IL-2 (n = 11) versus placebo (n = 17).
  
  
  CONCLUSIONS
  Neither ALVAC (vCP1452) nor low-dose daily IL-2 nor their combination prevented the relapse of viremia upon discontinuation of antiviral therapy.
authors.affiliation: The Division of Immunology, Department of Medicine, Weill Medical College of Cornell University, New York, New York, United States of America. kasmith@med.cornell.edu
authors.forename: Kendall A
authors.initials: KA
authors.lastname: Smith
authors.forename: Sofija
authors.initials: S
authors.lastname: Andjelic
authors.forename: Zoran
authors.initials: Z
authors.lastname: Popmihajlov
authors.forename: Liza
authors.initials: L
authors.lastname: Kelly-Rossini
authors.forename: Aquanette
authors.initials: A
authors.lastname: Sass
authors.forename: Martin
authors.initials: M
authors.lastname: Lesser
authors.forename: Steven
authors.initials: S
authors.lastname: Benkert
authors.forename: Cory
authors.initials: C
authors.lastname: Waters
authors.forename: Joyce
authors.initials: J
authors.lastname: Ruitenberg
authors.forename: Paul
authors.initials: P
authors.lastname: Bellman