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

Sponsor:	National Eye Institute (NEI)
Information provided by:	National Eye Institute (NEI)
ClinicalTrials.gov Identifier:	NCT00587496

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 I

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Herpes Simplex

Drug Information available for: Acetylsalicylic acid Valaciclovir Valacyclovir hydrochloride

U.S. FDA Resources

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
1: Experimental placebo, 6 capsules per day for 30 days	Drug: placebo lactose placebo capsule, six per day for 30 days
2: Experimental 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
3: Experimental 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

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

National Eye Institute (NEI)

Investigators

Principal Investigator:

Herbert E Kaufman, MD

LSU Eye Center, LSU Health Sciences Center

More Information

Publications:

Kaufman HE, Azcuy AM, Varnell ED, Sloop GD, Thompson HW, Hill JM. HSV-1 DNA in tears and saliva of normal adults. Invest Ophthalmol Vis Sci. 2005 Jan;46(1):241-7.

Lindgren KM, Douglas RG Jr, Couch RB. Significance of Herpesvirus hominis in respiratory secretions of man. N Engl J Med. 1968 Mar 7;278(10):517-23. No abstract available.

Douglas RG Jr, Couch RB. A prospective study of chronic herpes simplex virus infection and recurrent herpes labialis in humans. J Immunol. 1970 Feb;104(2):289-95. No abstract available.

Scott DA, Coulter WA, Biagioni PA, O'Neill HO, Lamey PJ. Detection of herpes simplex virus type 1 shedding in the oral cavity by polymerase chain reaction and enzyme-linked immunosorbent assay at the prodromal stage of recrudescent herpes labialis. J Oral Pathol Med. 1997 Aug;26(7):305-9.

Hobson A, Wald A, Wright N, Corey L. Evaluation of a quantitative competitive PCR assay for measuring herpes simplex virus DNA content in genital tract secretions. J Clin Microbiol. 1997 Mar;35(3):548-52.

Ryncarz AJ, Goddard J, Wald A, Huang ML, Roizman B, Corey L. Development of a high-throughput quantitative assay for detecting herpes simplex virus DNA in clinical samples. J Clin Microbiol. 1999 Jun;37(6):1941-7.

Kessler HH, Mühlbauer G, Rinner B, Stelzl E, Berger A, Dörr HW, Santner B, Marth E, Rabenau H. Detection of Herpes simplex virus DNA by real-time PCR. J Clin Microbiol. 2000 Jul;38(7):2638-42.

[No authors listed] Acyclovir for the prevention of recurrent herpes simplex virus eye disease. Herpetic Eye Disease Study Group. N Engl J Med. 1998 Jul 30;339(5):300-6.

Corey L, Wald A, Patel R, Sacks SL, Tyring SK, Warren T, Douglas JM Jr, Paavonen J, Morrow RA, Beutner KR, Stratchounsky LS, Mertz G, Keene ON, Watson HA, Tait D, Vargas-Cortes M; Valacyclovir HSV Transmission Study Group. Once-daily valacyclovir to reduce the risk of transmission of genital herpes. N Engl J Med. 2004 Jan 1;350(1):11-20.

Crumpacker CS. Use of antiviral drugs to prevent herpesvirus transmission. N Engl J Med. 2004 Jan 1;350(1):67-8. No abstract available.

Gebhardt BM, Varnell ED, Kaufman HE. Acetylsalicylic acid reduces viral shedding induced by thermal stress. Curr Eye Res. 2004 Aug-Sep;29(2-3):119-25.

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

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

Keywords provided by National Eye Institute (NEI):

HSV DNA
volunteers

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hematologic Agents
Fibrinolytic Agents
Valacyclovir
Fibrin Modulating Agents
Aspirin
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Herpes Simplex
Skin Diseases

Cyclooxygenase Inhibitors
Enzyme Inhibitors
Cardiovascular Agents
Antiviral Agents
Pharmacologic Actions
Herpesviridae Infections
Skin Diseases, Viral
Virus Diseases
Skin Diseases, Infectious
Acyclovir
Analgesics, Non-Narcotic
Platelet Aggregation Inhibitors
DNA Virus Infections
Peripheral Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 08, 2010