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, Mark A. Jacobson

Research output: Contribution to journalArticle

107 Scopus citations

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, 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.

Original languageEnglish (US)
Pages (from-to)48-56
Number of pages9
JournalJournal of Infectious Diseases
Volume177
Issue number1
StatePublished - 1998
Externally publishedYes

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ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health
  • Immunology

Cite this

Feinberg, J. E., Hurwitz, S., Cooper, D., Sattler, F. R., MacGregor, R. R., Powderly, W., Holland, G. N., Griffiths, P. D., Pollard, R. B., Youle, M., John Gill, M., Holland, F. J., Power, M. E., Owens, S., Coakley, D., Fry, J., & Jacobson, M. A. (1998). A randomized, double-blind trial of valaciclovir prophylaxis for cytomegalovirus disease in patients with advanced human immunodeficiency virus infection. Journal of Infectious Diseases, 177(1), 48-56.