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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Herpes Simplex

Intervention / Treatment
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* Drug: valacyclovir hydrochloride
* Drug: placebo
* Drug: valacyclovir plus aspirin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>placebo, 6 capsules per day for 30 days | Drug: placebo<br>* lactose placebo capsule, six per day for 30 days<br>|
| Experimental: 2<br>500 mg Valtrex one capsule per day plus 5 capsules of placebo per day for 30 days | Drug: valacyclovir hydrochloride<br>* 500 mg capsule, one per day for 30 days<br>* Other names: Valtrex;|
| Experimental: 3<br>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 | Drug: valacyclovir plus aspirin<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cessation of DNA shedding above the positive detection threshold |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HSV DNA, volunteers