       Document 0448
 DOCN  M9640448
 TI    Zidovudine side effects as reported by black, Hispanic, and
       white/non-Hispanic patients with early HIV disease: combined analysis of
       two multicenter placebo-controlled trials.
 DT    9604
 AU    Jacobson MA; Gundacker H; Hughes M; Fischl M; Volberding P; Department
       of Medicine, University of California San Francisco,; USA.
 SO    J Acquir Immune Defic Syndr Hum Retrovirol. 1995 Jan 1;11(1):45-52.
       Unique Identifier : AIDSLINE MED/96130046
 AB    The objective of this study was to determine whether HIV patients'
       subjective tolerance of zidovudine differs by racial or ethnic grouping
       by conducting a post hoc analysis of reported symptoms in two
       multicenter, placebo-controlled trials of zidovudine monotherapy for
       early HIV disease. Ratios of rates of developing new or worsening
       symptoms as reported by patients assigned to active drug or placebo were
       compared in groups of white/non-Hispanic, black, or Hispanic origin.
       Patients were included in the study if they had asymptomatic HIV disease
       and entry absolute CD4 lymphocyte counts below 500 cells/microL and were
       enrolled in National Institute of Allergy and Infectious Diseases AIDS
       Clinical Trials Group (ACTG) protocol 019 or had mild symptoms of HIV
       disease, were enrolled in ACTG protocol 016, met protocol eligibility
       criteria for the respective trial, and were categorized at entry as
       white/non-Hispanic (N = 1801), black (N = 195), or Hispanic (n = 214).
       The primary outcome measure was development of a new or worsening
       symptom of any severity. Among patients treated with zidovudine compared
       with placebo, the estimated risk for developing a new or worsening
       symptom was not significantly greater for blacks or Hispanics than for
       white/non-Hispanics for any of the most frequently reported symptoms (p
       > 0.05 after adjustment for the multiple comparisons performed). Our
       analysis of 195 black and 214 Hispanic patients did not reveal a
       significantly increased risk of subjective zidovudine intolerance
       compared with white/non-Hispanic subjects. If there is an increased risk
       of such intolerance in minority groups compared with
       white/non-Hispanics, it is not likely to be clinically important.
 DE    Acquired Immunodeficiency Syndrome/DRUG THERAPY/ETHNOLOGY  Adult
       Antiviral Agents/*ADVERSE EFFECTS/THERAPEUTIC USE  *Caucasoid Race
       Comparative Study  CD4 Lymphocyte Count  Disease/ETIOLOGY  Double-Blind
       Method  Female  *Hispanic Americans  Human  HIV Infections/*DRUG
       THERAPY/ETHNOLOGY  *HIV-1  Male  *Negroid Race  Risk Factors  Support,
       Non-U.S. Gov't  Support, U.S. Gov't, P.H.S.  Treatment Outcome
       Zidovudine/*ADVERSE EFFECTS/THERAPEUTIC USE  CLINICAL TRIAL  JOURNAL
       ARTICLE  MULTICENTER STUDY  RANDOMIZED CONTROLLED TRIAL

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

