30-Day Trial of Oral Valtrex or Valtrex Plus Aspirin on Shedding of HSV DNA in Tears and Saliva of Volunteers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by National Eye Institute (NEI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Eye Institute (NEI)
ClinicalTrials.gov Identifier:
NCT00587496
First received: December 21, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted

December 21, 2007
December 21, 2007
April 2006
July 2008   (final data collection date for primary outcome measure)
Cessation of DNA shedding above the positive detection threshold [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
30-Day Trial of Oral Valtrex or Valtrex Plus Aspirin on Shedding of HSV DNA in Tears and Saliva of Volunteers
A 30-Day Double-Masked Study to Determine the Effect of Oral Valacyclovir or Oral Valacyclovir Plus Aspirin on the Shedding of Herpes Simplex Virus DNA in the Tears and Saliva of Volunteers Without Clinical Signs of Ocular Herpetic Disease

The purpose of this study is to determine whether oral Valtrex alone or in combination with aspirin will reduce the shedding of herpes simplex virus DNA in the tears and saliva from volunteers with no evidence of ocular herpes infection. The secretion of virus into the tears and saliva might make people more susceptible to virus infection in the future if their immune system becomes deficient. The study will also try to determine if there is a correlation between shedding of viral DNA and herpes virus antibodies in serum and to determine if subjects are carriers of a special form of a gene in their blood cells, the presence of which may suggest the possibility of an increased susceptability to herpes and to Alzheimer's disease and heart disease.

Published studies have shown that treatment with oral acyclovir reduced clinical recurrences of ocular herpetic keratitis by about 40-50 %8, and treatment with valacyclovir, a more soluble prodrug of acyclovir, reduced the risk of transmission of genital herpes9, 10, 11. For this study, we will use the dose of valacyclovir that was shown effective in reducing the risk of transmission of HSV-2.9 The dose of 325 mg aspirin three times a day was chosen based on our experience with mice and other laboratory animals12. If it is effective and well tolerated at this dose, in future studies we will attempt to use lower doses and determine if they too may be effective.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Herpes Simplex
  • Drug: valacyclovir hydrochloride
    500 mg capsule, one per day for 30 days
    Other Name: Valtrex
  • Drug: placebo
    lactose placebo capsule, six per day for 30 days
  • Drug: valacyclovir plus aspirin
    500 mg valacyclovir capsule, one per day for 30 days 325 mg acetyl salicylic acid (aspirin) capsule, three per day for 30 days placebo capsule, two per day for 30 days
  • Experimental: 1
    placebo, 6 capsules per day for 30 days
    Intervention: Drug: placebo
  • Experimental: 2
    500 mg Valtrex one capsule per day plus 5 capsules of placebo per day for 30 days
    Intervention: Drug: valacyclovir hydrochloride
  • Experimental: 3
    500 mg Valtrex capsule one per day, Acetylsalicylic acid (aspirin) 325 mg capsules three per day, plus 2 placebo capsules per day for 30 days
    Intervention: Drug: valacyclovir plus aspirin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
July 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • either sex
  • any race
  • over age of 21 years

Exclusion Criteria:

  • have active ocular herpetic lesion
  • had ocular herpetic lesion in past 30 days
  • taking systemic or oral antiviral drugs
  • have taken antiviral drugs in the past 30 days
  • taking aspirin or NSAIDs
  • have dry eyes
  • have hypersensitivity to acyclovir or valacyclovir
  • have hypersensitivity of contraindication to use of aspirin
  • have bleeding disorder
  • have GI ulcer
  • have kidney impairment
  • are pregnant or nursing
  • have participated in a clinical trial in the past 30 days
Both
20 Years and older
Yes
Contact: Emily D Varnell, BS 504 568-2254 evarne@lsuhsc.edu
Contact: Robin Cooper, BS 504 568-2815 rcoope@lsuhsc.edu
United States
 
NCT00587496
6475, EY002672
Yes
Herbert E Kaufman, MD, Boyd Professor Ophthalmology, Pharmacology, Louisiana State University Health Sciences Center in New Orleans
National Eye Institute (NEI)
Not Provided
Principal Investigator: Herbert E Kaufman, MD LSU Eye Center, LSU Health Sciences Center
National Eye Institute (NEI)
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP