Journal Article

A Randomized Study of the Utility of Human Immunodeficiency Virus RNA Measurement for the Management of Antiretroviral Therapy

Richard H. Haubrich, Judith S. Currier, Donald N. Forthal, Gildon Beall, Carol A. Kemper, Debra Johnson, Michael P. Dubé, Jimmy Hwang, John M. Leedom, Jeremiah Tilles and J. Allen McCutchan

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 33, issue 7, pages 1060-1068
Published in print October 2001 | ISSN: 1058-4838
Published online October 2001 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/322636
A Randomized Study of the Utility of Human Immunodeficiency Virus RNA Measurement for the Management of Antiretroviral Therapy

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To compare frequent measurement with infrequent measurement of human immunodeficiency virus (HIV) RNA levels in the management of antiretroviral therapy, we conducted a clinical strategy study of 206 HIV-infected patients who had <500 CD4 cells/mm3. Patients were randomized (1.5 : 1) to undergo frequent monitoring (at baseline and every 2 months) or infrequent monitoring (at baseline and twice yearly), with CD4 cell counts determined every 2 months. Patients received unrestricted antiretroviral therapy. In the primary analysis (at month 6), the frequent group had a mean HIV RNA reduction (± standard deviation) of 0.93 ± 0.79 log10 copies/mL, versus 0.48 ± 0.83 log10 copies/mL for the infrequent group (P = .0002). A trend (P = .1) toward improved survival was seen in the frequent group. Given this iproved virological response, more frequent HIV RNA measurement than is recommended in published guidelines (every 3–4 months) may be appropriate.

Journal Article.  5580 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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