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A randomised, double-blind trial of valaciclovir prophylaxis for cytomegalovirus disease in patients with advanced human immunodeficiency virus infection.

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  • Judith E. Feinburg
  • Shelley Hurwitz
  • David Cooper
  • Fred R. Sattler
  • Rob Roy Macgregor
  • Gary N. Holland
  • Paul D. Griffiths
  • Richard Pollard
  • Michael Youle
  • M. John Gill
  • Fiona J Holland
  • . et al
<mark>Journal publication date</mark>01/1998
<mark>Journal</mark>Journal of Infectious Diseases
Issue number1
Number of pages9
Pages (from-to)48-56
Publication StatusPublished
<mark>Original language</mark>English


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, 8 g/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 33% 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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© University of Chicago Press 1998