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

Herpes Simplex Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00587496
• Other study ID #: 6475
• Secondary ID: EY002672
• Status: Recruiting
• Phase: Phase 1
• First received: December 21, 2007
• Last updated: December 21, 2007
• Start date: April 2006
• Est. completion date: July 2008

Study information

• Verified date: December 2007
• Source: National Eye Institute (NEI)
• Contact: Emily D Varnell, BS
• Phone: 504 568-2254
• Email: evarne[@]lsuhsc.edu
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Herpes Simplex

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Children's Hospital	New Orleans	Louisiana
United States	LSU Eye Center	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View Citation

Anon. New indications. Valtrex. FDA Drug Approvals 38:572-573, 2003.

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. — View Citation

Crumpacker CS. Use of antiviral drugs to prevent herpesvirus transmission. N Engl J Med. 2004 Jan 1;350(1):67-8. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cessation of DNA shedding above the positive detection threshold		30 days	No