30-Day Trial of Oral Valtrex or Valtrex Plus Aspirin on Shedding of HSV DNA in Tears and Saliva of Volunteers
Part of paid clinical trials in New Orleans, Louisiana.
- Sponsor
- National Eye Institute (NEI)
- Study ID
- NCT00587496
- Phase
- PHASE1
- Status
- Unknown
Conditions
- Herpes Simplex
Eligibility Criteria
- Sex
- ALL
- Age
- 20 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- valacyclovir hydrochloride — DRUG500 mg capsule, one per day for 30 days
- placebo — DRUGlactose placebo capsule, six per day for 30 days
- valacyclovir plus aspirin — DRUG500 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
Study Details
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.
Key Dates
- Start date
- Apr 30, 2006
- Status verified
- Dec 2007
- Primary completion
- Jul 31, 2008
- Completion
- Jul 31, 2008
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: 1placebo, 6 capsules per day for 30 days
- Experimental: 2500 mg Valtrex one capsule per day plus 5 capsules of placebo per day for 30 days
- Experimental: 3500 mg Valtrex capsule one per day, Acetylsalicylic acid (aspirin) 325 mg capsules three per day, plus 2 placebo capsules per day for 30 days
Primary Outcome Measure
Cessation of DNA shedding above the positive detection threshold [ Time Frame: 30 days ]
Central Contacts
- Emily D Varnell, BS504 568-2254
- Robin Cooper, BS504 568-2815
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Children's Hospital | New Orleans | Louisiana | 70118 | Herbert E Kaufman, MD (PRINCIPAL_INVESTIGATOR) |
| LSU Eye Center | New Orleans | Louisiana | 70112 | - |