30-Day Trial of Oral Valtrex or Valtrex Plus Aspirin on Shedding of HSV DNA in Tears and Saliva of Volunteers
NCT ID: NCT00587496
Last Updated: 2008-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
60 participants
INTERVENTIONAL
2006-04-30
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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1
placebo, 6 capsules per day for 30 days
placebo
lactose placebo capsule, six per day for 30 days
2
500 mg Valtrex one capsule per day plus 5 capsules of placebo per day for 30 days
valacyclovir hydrochloride
500 mg capsule, one per day for 30 days
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
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* any race
* over age of 21 years
Exclusion Criteria
* 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
20 Years
ALL
Yes
Sponsors
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National Eye Institute (NEI)
NIH
Responsible Party
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Louisiana State University Health Sciences Center in New Orleans
Principal Investigators
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Herbert E Kaufman, MD
Role: PRINCIPAL_INVESTIGATOR
LSU Eye Center, LSU Health Sciences Center
Locations
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LSU Eye Center
New Orleans, Louisiana, United States
Children's Hospital
New Orleans, Louisiana, United States
Countries
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Central Contacts
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References
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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.
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. doi: 10.1056/NEJM196803072781001. 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. doi: 10.1111/j.1600-0714.1997.tb00220.x.
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. doi: 10.1128/jcm.35.3.548-552.1997.
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. doi: 10.1128/JCM.37.6.1941-1947.1999.
Kessler 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.
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. doi: 10.1056/NEJM199807303390503.
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. doi: 10.1056/NEJMoa035144.
Crumpacker 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.
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. doi: 10.1080/02713680490504588.
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.
Other Identifiers
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EY002672
Identifier Type: -
Identifier Source: secondary_id
6475
Identifier Type: -
Identifier Source: org_study_id
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