@article{e4ebac38131b4497b44f3c0016d6dee4,
title = "A randomized, double-blind trial of valaciclovir prophylaxis for cytomegalovirus disease in patients with advanced human immunodeficiency virus infection",
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.",
author = "Feinberg, {Judith E.} and Shelley Hurwitz and David Cooper and Sattler, {Fred R.} and MacGregor, {Rob Roy} and William Powderly and Holland, {Gary N.} and Griffiths, {Paul D.} and Pollard, {Richard B.} and Michael Youle and {John Gill}, M. and Holland, {Fiona J.} and Power, {Maureen E.} and Susan Owens and Dion Coakley and John Fry and Jacobson, {Mark A.}",
note = "Funding Information: Financial support: NIH (AIDS Clinical Trials Group and participating AIDS Clinical Trials Units), Australian National Council on AIDS, Netherlands National AIDS Therapy Evaluation Centre, and Glaxo Wellcome. All non-US investigators received grants from Glaxo Wellcome for the conduct of the study, including authors D.C., M.Y., M.J.G.; all US ACTG investigators received limited grant support from Glaxo Wellcome for costs incurred for ophthalmologic monitoring and specimen shipment to the study repository in Texas, including authors J.E.F., F.R.S., R.R.M., W.P., R.B.P., and M.A.J. The investigators in charge of the two study virology laboratories and specimen repositories (R.B.P., P.D.G.) and the fundus photograph reading center (G.N.H.) received grants from Glaxo Wellcome for support of these activities. S.H. and G.N.H. received travel grants from Glaxo Wellcome to attend International Steering Committee meetings. Several authors have served as consultants to Glaxo Wellcome (J.E.F., P.D.G., M.A.J.). J.F. and D.C. were Glaxo Wellcome employees at the time the study was designed and conducted.",
year = "1998",
doi = "10.1086/513804",
language = "English",
volume = "177",
pages = "48--56",
journal = "Journal of Infectious Diseases",
issn = "0022-1899",
number = "1",
}