Document 0169
 DOCN  M9440169
 TI    Evaluation of the quality of life associated with zidovudine treatment
       in asymptomatic human immunodeficiency virus infection. The AIDS
       Clinical Trials Group.
 DT    9404
 AU    Lenderking WR; Gelber RD; Cotton DJ; Cole BF; Goldhirsch A; Volberding
       PA; Testa MA; Statistical and Data Analysis Center, Harvard School of
       Public; Health, Boston, MA 02115.
 SO    N Engl J Med. 1994 Mar 17;330(11):738-43. Unique Identifier : AIDSLINE
       MED/94150546
 AB    BACKGROUND. Zidovudine therapy is recommended for asymptomatic patients
       infected with the human immunodeficiency virus (HIV) who have fewer than
       500 CD4+ cells per cubic millimeter. An analysis of the quality of life
       associated with therapy that integrated both the effects of adverse
       events and the benefits of delayed disease progression might influence
       this recommendation. METHODS. We applied a survival analysis adjusted
       for the quality of life to data from a randomized trial conducted by the
       AIDS Clinical Trials Group. The trial compared treatment with 500 mg of
       zidovudine per day, 1500 mg of zidovudine per day, and placebo (Protocol
       019) in 1338 asymptomatic HIV-infected patients. RESULTS. The average
       time with neither a progression of disease nor an adverse event (symptom
       or laboratory finding) was 15.7, 15.6, and 14.8 months for patients
       receiving placebo, 500 mg of zidovudine, and 1500 mg of zidovudine,
       respectively. The incidence of severe symptoms was 13.8 percent in the
       placebo group, 15.2 percent in the 500-mg group, and 19.9 percent in the
       1500-mg group (P = 0.038). After 18 months, the 500-mg group gained an
       average of 0.5 months without disease progression, as compared with the
       placebo group, but had severe adverse events an average of 0.6 months
       sooner. The 500-mg group had more quality-of-life--adjusted time than
       the placebo group only if the time lived after the progression of
       disease was considered by a patient to have less value than the time
       after the occurrence of a severe symptom. CONCLUSIONS. For asymptomatic
       patients treated with 500 mg of zidovudine, a reduction in the quality
       of life due to severe side effects of therapy approximately equals the
       increase in the quality of life associated with a delay in the
       progression of HIV disease.
 DE    Double-Blind Method  Human  HIV Infections/*DRUG
       THERAPY/IMMUNOLOGY/MORTALITY  Leukocyte Count  *Quality of Life
       Retrospective Studies  Support, Non-U.S. Gov't  Support, U.S. Gov't,
       P.H.S.  Survival Analysis  T4 Lymphocytes  Zidovudine/ADVERSE
       EFFECTS/*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).