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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 recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by National Eye Institute (NEI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Eye Institute (NEI)
ClinicalTrials.gov Identifier:
NCT00587496
First received: December 21, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

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 Intervention Phase
Herpes Simplex
Drug: valacyclovir hydrochloride
Drug: placebo
Drug: valacyclovir plus aspirin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by National Eye Institute (NEI):

Primary Outcome Measures:
  • Cessation of DNA shedding above the positive detection threshold [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2006
Estimated Study Completion Date: July 2008
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587496

Contacts
Contact: Emily D Varnell, BS 504 568-2254 evarne@lsuhsc.edu
Contact: Robin Cooper, BS 504 568-2815 rcoope@lsuhsc.edu

Locations
United States, Louisiana
Children's Hospital Recruiting
New Orleans, Louisiana, United States, 70118
Principal Investigator: Herbert E Kaufman, MD         
LSU Eye Center Recruiting
New Orleans, Louisiana, United States, 70112
Sponsors and Collaborators
Investigators
Principal Investigator: Herbert E Kaufman, MD LSU Eye Center, LSU Health Sciences Center
  More Information

Publications:
Sheskin DJ. Handbook of Parametric and Nonparametric tatistical Procedures. 2nd Edition. Chapman & Hall/CRC, Boca Raton, FL pp. 982,2000.

Responsible Party: Herbert E Kaufman, MD, Boyd Professor Ophthalmology, Pharmacology, Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier: NCT00587496     History of Changes
Other Study ID Numbers: 6475, EY002672
Study First Received: December 21, 2007
Last Updated: December 21, 2007
Health Authority: United States: Federal Government

Keywords provided by National Eye Institute (NEI):
HSV DNA
volunteers

Additional relevant MeSH terms:
Herpes Simplex
DNA Virus Infections
Herpesviridae Infections
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Viral
Virus Diseases
Acyclovir
Aspirin
Valacyclovir
Analgesics
Analgesics, Non-Narcotic
Anti-Infective Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Antiviral Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on November 24, 2014