- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00587496
30-Day Trial of Oral Valtrex or Valtrex Plus Aspirin on Shedding of HSV DNA in Tears and Saliva of Volunteers
December 21, 2007 updated by: National Eye Institute (NEI)
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Emily D Varnell, BS
- Phone Number: 504 568-2254
- Email: evarne@lsuhsc.edu
Study Contact Backup
- Name: Robin Cooper, BS
- Phone Number: 504 568-2815
- Email: rcoope@lsuhsc.edu
Study Locations
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70112
- Recruiting
- LSU Eye Center
-
New Orleans, Louisiana, United States, 70118
- Recruiting
- Children's Hospital
-
Principal Investigator:
- Herbert E Kaufman, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
placebo, 6 capsules per day for 30 days
|
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
|
500 mg capsule, one per day for 30 days
Other Names:
|
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cessation of DNA shedding above the positive detection threshold
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Herbert E Kaufman, MD, LSU Eye Center, LSU Health Sciences Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Primary Completion (Anticipated)
July 1, 2008
Study Completion (Anticipated)
July 1, 2008
Study Registration Dates
First Submitted
December 21, 2007
First Submitted That Met QC Criteria
December 21, 2007
First Posted (Estimate)
January 7, 2008
Study Record Updates
Last Update Posted (Estimate)
January 7, 2008
Last Update Submitted That Met QC Criteria
December 21, 2007
Last Verified
December 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Virus Diseases
- Infections
- DNA Virus Infections
- Skin Diseases, Infectious
- Skin Diseases, Viral
- Herpesviridae Infections
- Herpes Simplex
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Aspirin
- Valacyclovir
Other Study ID Numbers
- 6475
- EY002672
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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