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

Last updated: December 21, 2007
Sponsor: National Eye Institute (NEI)
Overall Status: Trial Status Unknown

Phase

1

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT00587496
6475
EY002672
  • Ages > 20
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • either sex

  • any race

  • over age of 21 years

Exclusion

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

Study Design

Total Participants: 60
Study Start date:
April 01, 2006
Estimated Completion Date:
July 31, 2008

Study Description

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.

Connect with a study center

  • Children's Hospital

    New Orleans, Louisiana 70118
    United States

    Active - Recruiting

  • LSU Eye Center

    New Orleans, Louisiana 70112
    United States

    Active - Recruiting

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