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

• Status: Unknown status
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Eye Institute (NEI)
• Treatments: Acyclovir; Aspirin; Valacyclovir

Criteria

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