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A Randomized, Double-Blind Trial of Valaciclovir Prophylaxis for Cytomegalovirus Disease in Patients with Advanced Human Immunodeficiency Virus Infection

Judith E. Feinberg, Shelley Hurwitz, David Cooper, Fred R. Sattler, Rob Roy MacGregor, William Powderly, Gary N. Holland, Paul D. Griffiths, Richard B. Pollard, Michael Youle, M. John Gill, Fiona J. Holland, Maureen E. Power, Susan Owens, Dion Coakley, John Fry and Mark A. Jacobson
The Journal of Infectious Diseases
Vol. 177, No. 1 (Jan., 1998), pp. 48-56
Published by: Oxford University Press
Stable URL: http://www.jstor.org/stable/30107652
Page Count: 9
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A Randomized, Double-Blind Trial of Valaciclovir Prophylaxis for Cytomegalovirus Disease in Patients with Advanced Human Immunodeficiency Virus Infection
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Abstract

Cytomegalovirus (CMV) disease is a common complication of advanced human immunodeficiency virus (HIV) infection. Administration of oral valaciclovir, a valine ester of acyclovir, achieves sufficient plasma acyclovir levels to inhibit many clinical isolates. Acyclovir has been associated with enhanced survival in AIDS but not with CMV disease prevention. CMV-seropositive patients (1227) with CD4 cell counts <100/mm³ were enrolled in a randomized, double-blind trial. Valaciclovir, 0.8g/day, was compared with acyclovir, 3.2 or 0.8 g/day, for CMV prevention; all three arms were compared for survival. The confirmed CMV disease rate was 11.7% among valaciclovir recipients and 17.5% in the pooled acyclovir arms, a 3396 reduction in risk. Time to confirmed CMV disease was significantly longer for the valaciclovir group (P = .03). A trend toward earlier mortality for valaciclovir recipients was seen (P = .06). Toxicity and earlier medication discontinuation were more common in this group. Valaciclovir significantly reduces the risk of CMV disease. Further exploration of a better-tolerated dose is warranted.

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