Document 0490
 DOCN  M9650490
 TI    Long-term follow-up of symptomatic HIV-infected patients originally
       randomized to early versus later zidovudine treatment; report of a
       Veterans Affairs Cooperative Study. VA Cooperative Study Group on AIDS
       Treatment.
 DT    9605
 AU    Simberkoff MS; Hartigan PM; Hamilton JD; Day PL; Diamond GR; Dickinson
       GM; Drusano GL; Egorin MJ; George WL; Gordin FM; Hawkes CA; Jensen PC;
       Kilmas NG; Labriola AM; O'Brien WA; Oster CN; Weinhold KJ; Wray NP;
       Pazner SB; Department of Veterans Affairs Medical Centers, New York,
       New; York, Baltimore, Maryland, USA.
 SO    J Acquir Immune Defic Syndr Hum Retrovirol. 1996 Feb 1;11(2):142-50.
       Unique Identifier : AIDSLINE MED/96147314
 AB    Following a 4-year controlled trial comparing early and later zidovudine
       treatment, we conducted an additional 3-year follow-up. Of the original
       338 patients, 275 participated. Clinical outcome measures were AIDS and
       death. In the early therapy group (n = 170), 67 patients progressed to
       AIDS compared with 85 in the later therapy group (n = 168); the relative
       risk (RR) comparing early with later therapy was 0.72% (95% confidence
       interval [CI] 0.52-0.99; p = 0.044). The early therapy group had 74
       deaths compared with 73 in the later therapy (RR = 0.98; 95% CI,
       0.71-1.36; p = 0.91). The early group had a peak CD4+ count increase at
       1-2 months and a delay of 1 year before CD4+ counts fell below baseline.
       For patients who received zidovudine for more than the median duration
       (20.3 months) before their first AIDS diagnosis, the RR for death was
       2.08 (95% CI, 1.36-3.19, p = 0.001). Additional factors independently
       associated with poor prognosis following AIDS were a CD4+ count of < 100
       cells/mm3 and increased severity of the first AIDS diagnosis, whereas
       use of another antiretroviral agent was associated with improved
       survival. We conclude that early zidovudine therapy delays progression
       to AIDS but does not affect survival. Patients who progress to AIDS
       while on prolonged zidovudine monotherapy many benefit from a change to
       other antiretroviral therapy(ies).
 DE    Acquired Immunodeficiency Syndrome/ETIOLOGY/MORTALITY  Adult  Antiviral
       Agents/*THERAPEUTIC USE  Cohort Studies  CD4 Lymphocyte Count
       CD4-Positive T-Lymphocytes/IMMUNOLOGY  Disease Progression  Double-Blind
       Method  Female  Follow-Up Studies  Human  HIV Infections/*DRUG
       THERAPY/IMMUNOLOGY/PHYSIOPATHOLOGY  Longitudinal Studies  Male
       Randomized Controlled Trials  Support, U.S. Gov't, Non-P.H.S.  Survival
       Rate  Veterans  Zidovudine/*THERAPEUTIC USE  JOURNAL ARTICLE
       MULTICENTER STUDY

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