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The Safety and Efficacy of Zidovudine (AZT) in the Treatment of Subjects with Mildly Symptomatic Human Immunodeficiency Virus Type 1 (HIV) Infection: A Double-Blind, Placebo-Controlled Trial

Margaret A. Fischl, MD; Douglas D. Richman, MD; Nellie Hansen, MPH; Ann C. Collier, MD; John T. Carey, MD; Michael F. Para, MD; W. David Hardy, MD; Raphael Dolin, MD; William G. Powderly, MD; J. Davis Allan, MD; Brian Wong, MD; Thomas C. Merigan, MD; Vincent J. McAuliffe, MD; Newton E. Hyslop, MD; Frank S. Rhame, MD; Henry H. Balfour Jr., MD; Stephen A. Spector, MD; Paul Volberding, MD; Carla Pettinelli, MD, PhD; James Anderson, PhD, AIDS Clinical Trials Group*
[+] Article, Author, and Disclosure Information

Grant Support: In part by the AIDS Clinical Trials Group, National Institute of Allergy and Infectious Diseases, National Institutes of Health.

Requests for Reprints: Margaret A. Fischl, MD, University of Miami School of Medicine, Department of Medicine, R-60A, P.O. Box 016960, Miami, FL 33101.

Current Author Addresses: Dr. Fischl: University of Miami School of Medicine, Department of Medicine, R-60A, P.O. Box 016960, Miami, FL 33101.

Dr. Richman: Veterans Affairs Medical Center, Special Immunology, 3350 La Jolla Drive, V-111-F, San Diego, CA 92161.

Ms. Hansen: Research Triangle Institute, 3040 Cornwallis Road, Room 257, Research Triangle Park, NC 27709.

Dr. Collier: University of Washington, Harborview Medical Center, Department of Infectious Diseases, 325 9th Avenue, ZA-00, Seattle, WA 98104.

Dr. Carey: Case Western Reserve University, Infectious Diseases, 2074 Abington Road, Cleveland, OH 44106.

Dr. Para: The Ohio State University, Infectious Diseases, 4801 University Hospitals Clinic, 456 West 10th Avenue, Columbus, OH 43210.

Dr. Hardy: UCLA AIDS Clinical Research Center-University of California, Infectious Diseases, 10833 Le Conte Drive, 60-065 CHS, Los Angeles, CA 90024-1793.

Dr. Dolin: University of Rochester Medical Center, Department of Infectious Diseases, 601 Elmwood Avenue, Rochester, NY 14642.

Dr. Powderly: Washington University School of Medicine, Division of Infectious Diseases, Department of Medicine, 4511 Forest Park Parkway, Suite 304, St. Louis, MO 63108.

Dr. Allan: Harris Hall Clinic-New England Deaconess Hospital (Harvard ACTU), 185 Pilgrim Road, Boston, MA 02215.

Dr. Wong: University of Cincinnati, 231 Bethesda Avenue, Mail Code 560, Cincinnati, OH 45267.

Dr. Merigan: Stanford University School of Medicine, Division of Infectious Diseases, 300 Pasteur Drive, S156, Stanford, CA 94305.

Dr. McAuliffe: New York University, Department of Infectious Diseases, New Bellevue 16S5, 550 First Avenue, New York, NY 10016.

Dr. Hyslop: Tulane University School of Medicine, Section of Infectious Diseases, 1430 Tulane Avenue, New Orleans, LA 70112.

Dr. Rhame: University of Minnesota, Infectious Diseases, Harvard Street at East River, Minneapolis, MN 55455.

Dr. Balfour: University of Minnesota, Department of Laboratory Medicine and Pathology, Health Science Center, Box 437 UMHC, Minneapolis, MN 55455.

Dr. Spector: University of California at San Diego Medical Center, Division of Infectious Diseases, Department of Pediatrics, 225 Dickinson Street, H-814-H, San Diego, CA 92103.

Dr. Volberding: University of California at San Francisco General Hospital, Division of AIDS Activities, 995 Potrero Avenue, Ward 84, San Francisco, CA 94143.

Dr. Petinelli: National Institutes of Health, Division of AIDS, 6003 Executive Boulevard, Room 204 P, Rockville, MD 20892.

Dr. Anderson: University of Nebraska, Department of Preventive and Societal Medicine, 42nd and Dewey Avenue, Omaha, NE 68105-1065.

© 1990 American College of PhysiciansAmerican College of Physicians

Ann Intern Med. 1990;112(10):727-737. doi:10.7326/0003-4819-112-10-727
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Objective: To evaluate the efficacy and safety of zidovudine early in the treatment of human immunodeficiency virus type 1 (HIV) infection.

Design: A double-blind, randomized, placebo-controlled trial with subject stratification by pretreatment CD4 T lymphocyte counts.

Setting: Multicenter trial at AIDS Clinical Trials units.

Subjects: Seven hundred eleven subjects with mildly symptomatic HIV infection.

Intervention: Three hundred fifty-one subjects were assigned to placebo and 360 to zidovudine, 200 mg orally every 4 hours. The median duration of follow-up was 11 months.

Measurements and Main Results: Fifty-one subjects developed the acquired immunodeficiency syndrome (AIDS), advanced AIDS-related complex, or death as a first critical event. For the stratum of subjects with more than 200 but less than 500 CD4 T lymphocytes/mm3 before treatment, 34 events occurred in placebo recipients and 12 in zidovudine recipients (P = 0.0002; relative risk [RR] estimate, 3.23 [95% CI, 1.67 to 6.24]). For the stratum of subjects with 500 to 799 CD4 T lymphocytes/mm3 before treatment, 2 events occurred in placebo recipients and 3 in zidovudine recipients. Candidiasis at study entry independently increased the risk for having an event (P = 0.005; RR estimate, 2.3 [95% CI, 1.29 to 4.12]); HIV antigenemia at study entry also increased this risk (P = 0.01; RR estimate, 2.1 [95% CI, 1.2 to 3.8]). Significant differences between the treatment groups in CD4 T-lymphocyte counts occurred in subjects with more than 200 but less than 500 CD4 T lymphocytes/mm3 after 4 weeks of therapy (P = 0.002). Differences persisted through week 52. Less prominent changes occurred in subjects with 500 or more CD4 T lymphocytes/mm3. Serum levels of HIV antigen decreased significantly in zidovudine recipients. Serious anemia and neutropenia occurred in 5% and 4% of zidovudine recipients, respectively, and in 0% and 1% of placebo recipients, respectively.

Conclusion: Zidovudine delayed progression of HIV disease and produced little toxicity in subjects with mildly symptomatic HIV disease and less than 500 CD4 T lymphocytes/mm3.





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