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- Title
A randomized, double-blind trial of valaciclovir prophylaxis for cytomegalovirus disease in patients with advanced human immunodeficiency virus infection. AIDS Clinical Trials Group Protocol 204/Glaxo Wellcome 123-014 International CMV Prophylaxis Study Group.
- Authors
Feinberg, Judith E.; Hurwitz, Shelley; Cooper, David; Sattler, Fred R.; MacGregor, Rob Roy; Powderly, William; Holland, Gary N.; Griffiths, Paul D.; Pollard, Richard B.; Youle, Michael; Gill, M. John; Holland, Fiona J.; Power, Maureen E.; Owens, Susan; Coakley, Dion; Fry, John; Jacobson, Mark A.; Feinberg, J E; Hurwitz, S; Cooper, D
- 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.
- Publication
Journal of Infectious Diseases, 1998, Vol 177, Issue 1, p48
- ISSN
0022-1899
- Publication type
journal article
- DOI
10.1086/513804