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Results From a Placebo-Controlled Trial

Richard E. Chaisson, MD; Michael D. Leuther, PhD; Jean-Pierre Allain, MD, PhD; Sandra Nusinoff-Lehrman, MD; Gloria S. Boone, MS, MBA; David Feigal, MD, MPH; Paul Volberding

Arch Intern Med. 1988;148(10):2151-2153.

Abstract
• We assessed the effect of antiviral therapy on serum human immunodeficiency virus core antigen (HIV-Ag) levels in patients enrolled in the phase II trial on zidovudine for acquired immunodeficiency syndrome (AIDS) and AIDS—related complex. Human immunodeficiency virus core antigen was detected in 45% of subjects at entry (59% with AIDS and 37% of patients with AIDS—related complex). Median HIV-Ag levels in zidovudine-treated subjects fell from 111 pg/mL at entry to 46 pg/mL at four weeks, while levels in placebo recipients did not change significantly. Decline in HIV-Ag in zidovudine recipients was sustained through 16 weeks of treatment and was significantly different from the placebo group. Anti—p24 antibody levels did not change in either group. We conclude that in patients with HIV-antigenemia changes in HIV-Ag level are an important marker of anti—retroviral activity.

(Arch Intern Med 1988;148:2151-2153)

Author Affiliations
From the Medical Service, San Francisco General Hospital (Drs Chaisson, Feigal, and Volberding); Departments of Medicine (Drs Chaisson and Volberding), Epidemiology and International Health (Dr Feigal), University of California, San Francisco; Abbott Laboratories, Abbott Park, Ill (Drs Leuther and Allain); Burroughs Wellcome Co, Research Triangle Park, NC (Dr Nusinoff-Lehrman and Ms Boone). Dr Chaisson is presently with the Division of Infectious Diseases, Johns Hopkins Hospital, Baltimore. Presented in part at the third International Conference on AIDS, Washington, DC, June 1-5, 1987.

Footnotes
Accepted for publication June 3, 1988.

Reprint requests to Division of Infectious Diseases, Johns Hopkins Hospital, Blalock 1111, Baltimore, MD 21205 (Dr Chaisson).

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