Herpes Simplex
Conditions
Keywords
HSV DNA, volunteers
Brief 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.
Detailed 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.
Interventions
500 mg capsule, one per day for 30 days
DRUGplacebo
lactose placebo capsule, six per day for 30 days
DRUGvalacyclovir 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
Sponsors
National Eye Institute (NEI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cessation of DNA shedding above the positive detection threshold | 30 days |
Countries
United States
Contacts
Primary ContactEmily D Varnell, BS
Backup ContactRobin Cooper, BS
Outcome results
None listed