Document 0275
 DOCN  M9460275
 TI    Serum p24 antigen level as an intermediate end point in clinical trials
       of zidovudine in people infected with human immunodeficiency virus type
       1. Aids Clinical Trials Group Virology Laboratories.
 DT    9404
 AU    DeGruttola V; Beckett LA; Coombs RW; Arduino JM; Balfour HH Jr; Rasheed
       S; Hollinger FB; Fischl MA; Volberding P; Department of Biostatistics,
       Harvard School of Public Health,; Boston, Massachusetts.
 SO    J Infect Dis. 1994 Apr;169(4):713-21. Unique Identifier : AIDSLINE
       MED/94179878
 AB    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 (> or = 10 pg/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.
 DE    Acquired Immunodeficiency Syndrome/EPIDEMIOLOGY  Adult  AIDS-Related
       Complex/EPIDEMIOLOGY  Double-Blind Method  Female  Follow-Up Studies
       Human  HIV Core Protein p24/*BLOOD  HIV Infections/*DRUG
       THERAPY/ETIOLOGY/MORTALITY  HIV-1/*IMMUNOLOGY  Male  Pneumonia,
       Pneumocystis carinii/EPIDEMIOLOGY  Proportional Hazards Models  Risk
       Factors  Support, U.S. Gov't, P.H.S.  Survival Analysis  Time Factors
       Zidovudine/*THERAPEUTIC USE  CLINICAL TRIAL  JOURNAL ARTICLE  RANDOMIZED
       CONTROLLED TRIAL

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).