The effect of treatment with zidovudine with or without acyclovir on HIV p24 antigenaemia in patients with AIDS or AIDS-related complex.
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.
Pedersen
C
C
Hvidovre Hospital, Copenhagen, Denmark.
Cooper
D A
DA
Brun-Vézinet
F
F
Doherty
R
R
Skinhøj
P
P
Pérol
Y
Y
Lüthy
R
R
Leibowitch
J
J
Habermehl
K O
KO
Varnier
O E
OE
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*
D016655:HIV Core Protein p24; D015215:Zidovudine; D000212:Acyclovir