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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00587496
Recruitment Status : Unknown
Verified December 2007 by National Eye Institute (NEI).
Recruitment status was:  Recruiting
First Posted : January 7, 2008
Last Update Posted : January 7, 2008
Information provided by:
National Eye Institute (NEI)

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.

Condition or disease Intervention/treatment Phase
Herpes Simplex Drug: valacyclovir hydrochloride Drug: placebo Drug: valacyclovir plus aspirin Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : April 2006
Estimated Primary Completion Date : July 2008
Estimated Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
placebo, 6 capsules per day for 30 days
Drug: placebo
lactose placebo capsule, six per day for 30 days

Experimental: 2
500 mg Valtrex one capsule per day plus 5 capsules of placebo per day for 30 days
Drug: valacyclovir hydrochloride
500 mg capsule, one per day for 30 days
Other Name: Valtrex

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
Drug: 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 Measures :
  1. Cessation of DNA shedding above the positive detection threshold [ Time Frame: 30 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00587496

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Contact: Emily D Varnell, BS 504 568-2254
Contact: Robin Cooper, BS 504 568-2815

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United States, Louisiana
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         
Sponsors and Collaborators
National Eye Institute (NEI)
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Principal Investigator: Herbert E Kaufman, MD LSU Eye Center, LSU Health Sciences Center
Anon. New indications. Valtrex. FDA Drug Approvals 38:572-573, 2003.
Sheskin DJ. Handbook of Parametric and Nonparametric tatistical Procedures. 2nd Edition. Chapman & Hall/CRC, Boca Raton, FL pp. 982,2000.

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Responsible Party: Herbert E Kaufman, MD, Boyd Professor Ophthalmology, Pharmacology, Louisiana State University Health Sciences Center in New Orleans Identifier: NCT00587496    
Other Study ID Numbers: 6475
First Posted: January 7, 2008    Key Record Dates
Last Update Posted: January 7, 2008
Last Verified: December 2007
Keywords provided by National Eye Institute (NEI):
Additional relevant MeSH terms:
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Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antiviral Agents
Anti-Infective Agents