Recruiting
Phase 1

Valtrex & Aspirin

Sponsor:

National Eye Institute (NEI)

Code:

NCT00587496

Conditions

Herpes Simplex

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Accepted

Interventions

valacyclovir hydrochloride

placebo

valacyclovir plus aspirin

Study Details

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.

Conditions

Herpes Simplex

Study ID

NCT00587496

Start date

Apr, 2006

Status verified date

Dec, 2007

Completion date

Jul, 2008

Anticipated

Primary completion date

Jul, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 1

placebo, 6 capsules per day for 30 days

experimental: 2

500 mg Valtrex one capsule per day plus 5 capsules of placebo per day for 30 days

experimental: 3

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

Interventions

valacyclovir hydrochloride

500 mg capsule, one per day for 30 days

placebo

lactose placebo capsule, six per day for 30 days

valacyclovir 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

Primary outcome measure

  • Cessation of DNA shedding above the positive detection threshold [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Emily D Varnell, BS

504 568-2254evarne@lsuhsc.edu

Robin Cooper, BS

504 568-2815rcoope@lsuhsc.edu

Locations

LSU Eye Center

Recruiting

New Orleans, Louisiana, United States, 70112

Children's Hospital

Recruiting

New Orleans, Louisiana, United States, 70118

Principal Investigator:

Herbert E Kaufman, MD

More Information

Sponsor

National Eye Institute (NEI)

Last update posted

Jan 7, 2008

Last verified

Dec, 2007

Keywords

  • HSV DNA
  • volunteers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Eye Institute (NEI) on 2008-01-07.