title: The effect of treatment with zidovudine with or without acyclovir on HIV p24 antigenaemia in patients with AIDS or AIDS-related complex.
abstract: OBJECTIVE
  To evaluate changes in serum HIV p24-antigen levels in a subset of patients who participated in a European/Australian double-blind, placebo-controlled trial evaluating the efficacy of zidovudine (250 mg every 6 h) alone or in combination with acyclovir (800 mg every 6 h) in patients with AIDS, AIDS-related complex (ARC) or Kaposi's sarcoma (KS).
  
  
  METHODS
  Double-blind, placebo-controlled randomized clinical trial of less than or equal to 6 months' therapy.
  
  
  METHODS
  Samples were obtained from patients attending teaching hospital outpatient clinics in seven European countries and Australia.
  
  
  METHODS
  One hundred and ninety-seven HIV-infected patients (60 with AIDS and 137 with ARC or KS).
  
  
  METHODS
  Serum HIV p24-antigen levels measured using the Abbott HIV solid-phase enzyme immunoassay.
  
  
  RESULTS
  Of 76 ARC/KS patients who were initially HIV p24-antigen-positive, one out of 25 randomized to placebo, eight out of 23 to zidovudine and 11 out of 28 to the zidovudine/acyclovir combination became antigen-negative. The proportion of patients who became antigen-negative was significantly higher in both the zidovudine group (P = 0.016) and the zidovudine/acyclovir group (P = 0.004), compared with the placebo group. There were no statistical differences between the zidovudine and the zidovudine/acyclovir groups. During the trial p24-antigen levels in the zidovudine-treated patients reached their minimum after 4-8 weeks of therapy, and tended to increase gradually thereafter. Disease progression occurred irrespective of whether p24-antigen levels declined during therapy. No association between p24-antigen responses to therapy and baseline disease stage, Karnofsky score or baseline CD4 cell count was detectable.
  
  
  CONCLUSIONS
  Acyclovir does not potentiate the effect of zidovudine on p24-antigen levels. Change in antigen level in response to antiviral therapy needs further investigation before it is used as a surrogate marker for clinical efficacy of antiviral therapy.
authors.affiliation: Hvidovre Hospital, Copenhagen, Denmark.
authors.forename: C
authors.initials: C
authors.lastname: Pedersen
authors.forename: D A
authors.initials: DA
authors.lastname: Cooper
authors.forename: F
authors.initials: F
authors.lastname: Brun-Vézinet
authors.forename: R
authors.initials: R
authors.lastname: Doherty
authors.forename: P
authors.initials: P
authors.lastname: Skinhøj
authors.forename: Y
authors.initials: Y
authors.lastname: Pérol
authors.forename: R
authors.initials: R
authors.lastname: Lüthy
authors.forename: J
authors.initials: J
authors.lastname: Leibowitch
authors.forename: K O
authors.initials: KO
authors.lastname: Habermehl
authors.forename: O E
authors.initials: OE
authors.lastname: Varnier
mesh_terms: D000386:AIDS-Related Complex / Q000188:drug therapy* / Q000276:immunology; D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy* / Q000276:immunology; D000212:Acyclovir / Q000494:pharmacology / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D016655:HIV Core Protein p24 / Q000097:blood* / Q000187:drug effects; D006801:Humans; D015215:Zidovudine / Q000494:pharmacology / Q000627:therapeutic use*
chemical_list: D016655:HIV Core Protein p24; D015215:Zidovudine; D000212:Acyclovir