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Cited by 1,283

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Zidovudine in Asymptomatic Human Immunodeficiency Virus Infection: A Controlled Trial in Persons with Fewer Than 500 CD4-Positive Cells per Cubic Millimeter

Open access
Volberding, Paul A., Lagakos, Stephen W., Koch, Matthew A., Pettinelli, Carla, Myers, Maureen W., Booth, David K., Balfour, Henry H., Reichman, Richard C., Bartlett, John A., Hirsch, Martin S., Murphy, Robert L., Hardy, W. David, Soeiro, Ruy, Fischl, Margaret A., Bartlett, John G., Merigan, Thomas C., Hyslop, Newton E., Richman, Douglas D., Valentine, Fred T., Corey, Lawrence, the AIDS Clinical Trials Group of the National Institute of Allergy and Infectious Diseases*·1990·New England Journal of Medicine

Abstract

Zidovudine (AZT) is a potent inhibitor of the replication of the human immunodeficiency virus (HIV), and it has been shown to improve survival in advanced HIV disease. We conducted a randomized, double-blind trial in adults with asymptomatic HIV infection who had CD4+ cell counts of fewer than 500 per cubic millimeter on entry into the study. The subjects (92 percent male) were randomly assigned to one of three treatment groups: placebo (428 subjects); zidovudine, 500 mg per day (453); or zidovudine, 1500 mg per day (457). After a mean follow-up of 55 weeks (range, 19 to 107), 33 of the subjects assigned to placebo had the acquired immunodeficiency syndrome (AIDS), as compared with 11 of those assigned to receive 500 mg of zidovudine (P = 0.002; relative risk, 2.8; 95 percent confidence interval, 1.4 to 5.6) and 14 of those assigned to receive 1500 mg of zidovudine (P = 0.05; relative risk, 1.9; 95 percent confidence interval, 1.0 to 3.5). In the three treatment groups, the rates of progression (per 100 person-years) to either AIDS or advanced AIDS-related complex were 7.6, 3.6, and 4.3, respectively. As compared with those assigned to placebo, the subjects in the zidovudine groups had significant increases in the number of CD4+ cells and significant declines in p24 antigen levels. In the 1500-mg zidovudine group, severe hematologic toxicity (anemia or neutropenia) was more frequent than in the other groups (P less than 0.0001). In the 500-mg zidovudine group, nausea was the only toxicity that was significantly more frequent (in 3.3 percent) than in the placebo group (P = 0.001). We conclude that zidovudine is safe and effective in persons with asymptomatic HIV infection and fewer than 500 CD4+ cells per cubic millimeter. Additional study will be required to determine whether such treatment will ultimately improve survival for persons infected with HIV.

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Metadata

Authors
Volberding, P. A., Lagakos, S. W., Koch, M. A., Pettinelli, C., Myers, M. W., Booth, D. K., Balfour, H. H., Reichman, R. C., Bartlett, J. A., Hirsch, M. S., Murphy, R. L., Hardy, W. D., Soeiro, R., Fischl, M. A., Bartlett, J. G., Merigan, T. C., Hyslop, N. E., Richman, D. D., Valentine, F. T., Corey, L., & the AIDS Clinical Trials Group of the National Institute of Allergy and Infectious Diseases*
Venue
New England Journal of Medicine
Published
1990-04-05
Volume
322
Issue
14
Pages
941-949
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2009226722
Cited by
1,283
References
5
FWCI
181.02
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: Zidovudine in Asymptomatic Human Immunodeficiency Virus Infection: A Controlled Trial in Persons with Fewer Than 500 CD4-Positive Cells per Cubic Millimeter. https://app.cochat.ai/papers/10.1056/nejm199004053221401
The paper
Volberding, P. A., Lagakos, S. W., Koch, M. A., Pettinelli, C., Myers, M. W., Booth, D. K., Balfour, H. H., Reichman, R. C., Bartlett, J. A., Hirsch, M. S., Murphy, R. L., Hardy, W. D., Soeiro, R., Fischl, M. A., Bartlett, J. G., Merigan, T. C., Hyslop, N. E., Richman, D. D., Valentine, F. T., . . . the AIDS Clinical Trials Group of the National Institute of Allergy and Infectious Diseases*. (1990). Zidovudine in Asymptomatic Human Immunodeficiency Virus Infection: A Controlled Trial in Persons with Fewer Than 500 CD4-Positive Cells per Cubic Millimeter. New England Journal of Medicine. https://doi.org/10.1056/nejm199004053221401

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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.

Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.