Serum p24 antigen level as an intermediate end point in clinical trials of zidovudine in people infected with human immunodeficiency virus type 1

Victor DeGruttola, Laurel A Beckett, Robert W. Coombs, Jean Marie Arduino, Henry H. Balfour, Suraiya Rasheed, F. Blaine Hollinger, Margaret A. Fischl, Paul Volberding

Research output: Contribution to journalArticle

31 Scopus citations

Abstract

Serum p24 antigen levels were examined in subjects from three clinical trials of zidovudine to determine whether the pattern of change in serum p24 antigen during the first 8-16 weeks of therapy was associated with human immunodeficiency virus type 1 (HIV-1) disease progression or death. Among 406 patients with AIDS and a first episode of Pneumocystis carinii pneumonia, 65% had measurable pretreatment concentrations of serum p24 antigen (≥10 ng/mL). Changes during treatment were not associated with reduced mortality. In 637 mildly symptomatic patients, 24% had measurable concentrations, and changes were marginally associated with increased time until more advanced disease. Among 683 asymptomatic patients, 18% had measurable concentrations, and changes were not associated with increased time until progression. Despite the small number of clinical events and the low rate of serum p24 antigen positivity in the latter two studies, pretreatment serum p24 antigen levels were predictive of clinical outcome; subsequent measurements appear to be of limited use in evaluating zidovudine therapy.

Original languageEnglish (US)
Pages (from-to)713-721
Number of pages9
JournalJournal of Infectious Diseases
Volume169
Issue number4
StatePublished - Apr 1994
Externally publishedYes

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health
  • Immunology

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