Abstract

The major current focus of this project is a randomized, multicenter, double-blind, placebo-controlled Phase III study to evaluate the effect of valaciclovir in preventing the transmission of herpes simplex virus (HSV) in heterosexual couples discordant for the presence of herpes simplex type 2 virus (HSV-2) antibody. The seropositive source partner is randomized to receive valaciclovir 500 mg once daily or placebo for 8 months, and the susceptible seronegative partner is monitored for clinical and subclinical (serological) acquisition of HSV. A total of 1500 couples will be randomized into the study, at approximately 100 outpatient centers in the United States, Canada and Europe. At the NIH, 32 couples have been randomized into this study, with an aim of enrolling a total of 40 couples.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Intramural Research (Z01)
Project #
1Z01AI000836-03
Application #
6431705
Study Section
(LCI)
Project Start
Project End
Budget Start
Budget End
Support Year
3
Fiscal Year
2000
Total Cost
Indirect Cost

  Institution

Name
Niaid Extramural Activities
Department
Type
DUNS #
City
State
Country
United States
Zip Code

  Publications

Marques, A R; Straus, S E; Fahle, G et al. (2001) Lack of association between HSV-1 DNA in the brain, Alzheimer's disease and apolipoprotein E4. J Neurovirol 7:82-3
Marques, A R; Straus, S E (2000) Herpes simplex type 2 infections--an update. Adv Intern Med 45:175-208
Marques, A R; Straus, S E (2000) Herpes simplex type 2 infections--an update. Dis Mon 46:325-59