30-Day Trial of Oral Valtrex or Valtrex Plus Aspirin on Shedding of HSV DNA in Tears and Saliva of Volunteers
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
2 other identifiers
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2006
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 21, 2007
CompletedFirst Posted
Study publicly available on registry
January 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedJanuary 7, 2008
December 1, 2007
2.3 years
December 21, 2007
December 21, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cessation of DNA shedding above the positive detection threshold
30 days
Study Arms (3)
1
EXPERIMENTALplacebo, 6 capsules per day for 30 days
2
EXPERIMENTAL500 mg Valtrex one capsule per day plus 5 capsules of placebo per day for 30 days
3
EXPERIMENTAL500 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
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
Eligibility Criteria
You may qualify if:
- either sex
- any race
- over age of 21 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
LSU Eye Center
New Orleans, Louisiana, 70112, United States
Children's Hospital
New Orleans, Louisiana, 70118, United States
Related Publications (13)
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. doi: 10.1167/iovs.04-0614.
PMID: 15623779BACKGROUNDLindgren 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. doi: 10.1056/NEJM196803072781001. No abstract available.
PMID: 4295319BACKGROUNDDouglas 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.
PMID: 4312871BACKGROUNDScott 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. doi: 10.1111/j.1600-0714.1997.tb00220.x.
PMID: 9250929BACKGROUNDHobson 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. doi: 10.1128/jcm.35.3.548-552.1997.
PMID: 9041386BACKGROUNDRyncarz 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. doi: 10.1128/JCM.37.6.1941-1947.1999.
PMID: 10325351BACKGROUNDKessler HH, Muhlbauer G, Rinner B, Stelzl E, Berger A, Dorr 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. doi: 10.1128/JCM.38.7.2638-2642.2000.
PMID: 10878056BACKGROUNDAcyclovir 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. doi: 10.1056/NEJM199807303390503.
PMID: 9696640BACKGROUNDCorey 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. doi: 10.1056/NEJMoa035144.
PMID: 14702423BACKGROUNDCrumpacker CS. Use of antiviral drugs to prevent herpesvirus transmission. N Engl J Med. 2004 Jan 1;350(1):67-8. doi: 10.1056/NEJMe038189. No abstract available.
PMID: 14702430BACKGROUNDGebhardt 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. doi: 10.1080/02713680490504588.
PMID: 15512958BACKGROUNDAnon. New indications. Valtrex. FDA Drug Approvals 38:572-573, 2003.
BACKGROUNDSheskin DJ. Handbook of Parametric and Nonparametric tatistical Procedures. 2nd Edition. Chapman & Hall/CRC, Boca Raton, FL pp. 982,2000.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Herbert E Kaufman, MD
LSU Eye Center, LSU Health Sciences Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
December 21, 2007
First Posted
January 7, 2008
Study Start
April 1, 2006
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
January 7, 2008
Record last verified: 2007-12