A controlled trial of early versus late treatment with zidovudine in symptomatic human immunodeficiency virus infection : results of the Veterans Affairs Cooperative Study

Zidovudine is recommended for asymptomatic and early symptomatic human immunodeficiency virus (HIV) infection. The best time to initiate zidovudine treatment remains uncertain, however, and whether early treatment improves survival has not been established. We conducted a multicenter, randomized, do...

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Published in:	The New England journal of medicine Vol. 326; no. 7; pp. 437 - 443
Main Authors:	HAMILTON, J. D, HARTIGAN, P. M, HAWKES, C. A, JENSEN, P. C, KLIMAS, N. G, LABRIOLA, A. M, LAHART, C. J, O'BRIEN, W. A, OSYTER, C. N, WEINHOLD, K. J, WRAY, N. P, ZOLLA-PAZNER, S. B, SIMBERKOFF, M. S, DAY, P. L, DIAMOND, G. R, DICKINSON, G. M, DRUSANO, G. L, EGORIN, M. J, GEORGE, W. L, GORDIN, F. M
Format:	Journal Article
Language:	English
Published:	Boston, MA Massachusetts Medical Society 13-02-1992
Subjects:	Acquired Immunodeficiency Syndrome - drug therapy Adult Antibiotics. Antiinfectious agents. Antiparasitic agents Antiviral agents Biological and medical sciences CD4-Positive T-Lymphocytes Double-Blind Method Female Follow-Up Studies HIV Infections - drug therapy HIV Infections - mortality human immunodeficiency virus Humans Leukocyte Count Male Medical sciences Patient Compliance Pharmacology. Drug treatments Survival Rate Time Factors Zidovudine - administration & dosage Zidovudine - adverse effects Human Late Retroviridae Controlled therapeutic trial AIDS Infection Virus Chemotherapy Treatment Viral disease T-Lymphocyte Lentivirinae Antiviral Early Human immunodeficiency virus
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Summary:	Zidovudine is recommended for asymptomatic and early symptomatic human immunodeficiency virus (HIV) infection. The best time to initiate zidovudine treatment remains uncertain, however, and whether early treatment improves survival has not been established. We conducted a multicenter, randomized, double-blind trial that compared early zidovudine therapy (beginning at 1500 mg per day) with late therapy in HIV-infected patients who were symptomatic and had CD4+ counts between 0.2 x 10(9) and 0.5 x 10(9) cells per liter (200 to 500 per cubic millimeter) at entry. Those assigned to late therapy initially received placebo and began zidovudine when their CD4+ counts fell below 0.2 x 10(9) per liter (200 per cubic millimeter) or when the acquired immunodeficiency syndrome (AIDS) developed. During a mean follow-up period of more than two years, there were 23 deaths in the early-therapy group (n = 170) and 20 deaths in the late-therapy group (n = 168) (P = 0.48; relative risk [late vs. early], 0.81; 95 percent confidence interval, 0.44 to 1.59). In the early-therapy group, 28 patients progressed to AIDS, as compared with 48 in the late-therapy group (P = 0.02; relative risk, 1.76; 95 percent confidence interval, 1.1 to 2.8). Early therapy increased the time until CD4+ counts fell below 0.2 x 10(9) per liter (200 per cubic millimeter), and it produced more conversions from positive to negative for serum p24 antigen. Early therapy was associated with more anemia, leukopenia, nausea, vomiting, and diarrhea, whereas late therapy was associated with more skin rash. In symptomatic patients with HIV infection, early treatment with zidovudine delays progression to AIDS, but in this controlled study it did not improve survival, and it was associated with more side effects.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23
ISSN:	0028-4793 1533-4406
DOI:	10.1056/NEJM199202133260703