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Stefano Vella, MD; Marina Giuliano, MD; Patrizio Pezzotti, PhD; Maria Grazia Agresti, MD; Carlo Tomino, PhD; Marco Floridia, MD; Donato Greco, MD; Mauro Moroni, MD; Giuseppe Visco, MD; Francesco Milazzo, MD; Fabio Giannelli, MD; Gioacchino Angarano, MD; Luigi Ortona, MD; Carlo Zanussi, MD; Italian Zidovudine Evaluation Group; Mauro Barbanera, MD; Aurelio Cajozzo, MD; Gian Franco Calonghi, MD; Ruggero Caputo, MD; Pier Giuseppe Fassio, MD; Paolo Gioannini, MD; Adriano Lazzarin; Giuseppe Manzillo; Giovanni Mazzarello, MD; Domenico Milo, MD; Nicolò Piersantelli, MD; Silverio Piro, MD; Sergio Ranieri, MD; Pietro Ricciardiello; Fortunato Rizzo, MD; Giorgio Scalise, MD; Antonio Scasso, MD; Fredy Suter, MD

JAMA. 1992;267(9):1232-1236.

Abstract
Objective.
—To assess the long-term effectiveness of zidovudine (AZT) in patients with acquired immunodeficiency syndrome (AIDS). This assessment has never been adequately done because controlled clinical trials were stopped early and survival comparisons were made with historical controls.

Design.
—Nonrandomized contemporary observational study of patients treated and not treated with zidovudine.

Setting.
—Twenty-three AIDS treatment centers throughout Italy that reported cases to the National Registry of AIDS Cases between July 1987 and March 1988.

Patients.
—One hundred fifty-nine zidovudine-treated and 112 untreated patients with AIDS, the majority of whom had acquired human immunodeficiency virus (HIV) infection through intravenous drug use.

Outcome Measures.
—Median survival and 1- and 2-year survival for treated and untreated groups, as estimated using the Kaplan-Meier method. Cox proportional hazards regression analysis was also used to identify independent predictors of survival among the variables studied.

Results.
—Patients were similar with respect to CD4/CD8 ratio, age, sex, clinical and immunological status at diagnosis, and source of HIV infection. After 24 months, survival was 45.9% (95% confidence interval [Cl], 36.1% to 55.7%) in the treated group and 20.5% (95% Cl, 12.6% to 28.3%) in the untreated group, with median survival of 21.2 and 9.6 months, respectively.

Conclusions.
—Possible biases of this study include imperfect matching for clinical status and better overall medical care of treated patients. Nevertheless, we believe that the observed differences in survival were primarily due to zidovudine treatment.

(JAMA. 1992;267:1232-1236)

Author Affiliations
Spedali Riuniti, Livorno; University of Palermo; Arcispedale Santa Maria Nuova, Reggio Emilia; University of Milan; Ospedali Riuniti, Bergamo; University of Turin; University of Milan; Ospedale Cotugno, Napoli; University of Genova; Ospedale Careggi, Firenze; Ospedali Galliera, Genova; Ospedale Santissima Trinità, Cagliari; Ospedale Santa Maria delle Croci, Ravenna; Ospedale Maggiore, Novara; Ospedale San Martino, Genova; University of Ancona; Ospedale di Pisa; Ospedale di Busto Arsisio

From the Laboratory of Virology and Centro Operativo AIDS, Istituto Superiore di Sanità, Rome (Drs Vella, Giuliano, Pezzotti, Agresti, Tomino, Floridia, and Greco), Institute of Infectious Diseases, University of Milan (Dr Moroni), Ospedale Spallanzani, Rome (Dr Visco), Ospedale L. Sacco, Milan (Dr Milazzo), Ospedale Niguarda, Milan (Dr Giannelli), Institute of Internal Medicine and Infectious Diseases, University of Bari (Dr Angarano), Catholic University of Rome (Dr Ortona), and Institute of Internal Medicine, University of Milan (Dr Zanussi), Italy.

Footnotes
Reprint requests to Laboratory of Virology, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161 Rome, Italy (Dr Vella).

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