30-Day Trial of Oral Valtrex or Valtrex Plus Aspirin on Shedding of HSV DNA in Tears and Saliva of Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 20 - Any |
| Updated: | 4/2/2016 |
| Start Date: | April 2006 |
| End Date: | July 2008 |
| Contact: | Emily D Varnell, BS |
| Email: | evarne@lsuhsc.edu |
| Phone: | 504 568-2254 |
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.
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.
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.
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
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