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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.
- Source :
-
The Journal of infectious diseases [J Infect Dis] 1998 Jan; Vol. 177 (1), pp. 48-56. - Publication Year :
- 1998
-
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.
- Subjects :
- AIDS-Related Opportunistic Infections prevention & control
AIDS-Related Opportunistic Infections virology
Acyclovir administration & dosage
Acyclovir adverse effects
Administration, Oral
Adult
Antiviral Agents administration & dosage
Antiviral Agents adverse effects
CD4 Lymphocyte Count
Cytomegalovirus Infections diagnosis
Cytomegalovirus Infections prevention & control
Double-Blind Method
Female
Humans
Male
Valacyclovir
Valine administration & dosage
Valine adverse effects
Valine therapeutic use
AIDS-Related Opportunistic Infections drug therapy
Acyclovir analogs & derivatives
Acyclovir therapeutic use
Antiviral Agents therapeutic use
Cytomegalovirus Infections drug therapy
Valine analogs & derivatives
Subjects
Details
- Language :
- English
- ISSN :
- 0022-1899
- Volume :
- 177
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- The Journal of infectious diseases
- Publication Type :
- Academic Journal
- Accession number :
- 9419169
- Full Text :
- https://doi.org/10.1086/513804