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1996-03-09
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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
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).