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.

Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.

J Acquir Immune Defic Syndr Hum Retrovirol. 1996 Feb 1;11(2):142-50. Unique Identifier : AIDSLINE MED/96147314
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.

Abstract: 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).

Keywords: 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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