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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COMPLETED
36 participants
OBSERVATIONAL
2007-06-30
2012-03-31
Brief Summary
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Detailed Description
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Participants are asked to visit the University of Washington Virology Research Clinic for an initial screening appointment in which the clinician will ensure eligibility and informed consent will be obtained.
Participants who experience an outbreak during the next year will be asked to call the clinic at the beginning of their next outbreak. The clinician will arrange to admit the participant to the UW General Clinical Research Center (GCRC) for a 5-day hospitalization stay. During hospitalization, participants will take acyclovir (400mg 3 times daily) and genital swabs will be collected every 2 hours during the day and every 4 hours at night for 5 days. After the last swab has been taken, the study nurse at the GCRC will do a final genital exam and the participant will be discharged. Some participants will also be asked to enroll in a control arm during which the same procedures will be followed except they will not take acyclovir during the recurrence.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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1
HSV-2 seropositive subjects who will receive a 5-day course of acyclovir for treatment of a genital herpes recurrence.
acyclovir
400 mg acyclovir, orally three times a day for 5 days
2
HSV-2 seropositive subjects who will be observed during a genital herpes recurrence but not receive acyclovir.
No interventions assigned to this group
Interventions
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acyclovir
400 mg acyclovir, orally three times a day for 5 days
Eligibility Criteria
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Inclusion Criteria
* History of clinically-evident genital herpes
* 3 or more clinical genital herpes recurrences within the prior 12 months
* HSV-2 seropositive by HSV Western Blot
* Willing and able to comply with study protocol
Exclusion Criteria
* Taking daily antiviral therapy for genital herpes
* HIV seropositive or known immunocompromising medical condition
* Plan to move from the Seattle area within the next year
* Hypersensitivity to or intolerance of acyclovir
18 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
University of Washington
OTHER
Responsible Party
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Anna Wald
Principal Investigator
Principal Investigators
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Anna Wald, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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University of Washington Virology Research Clinic
Seattle, Washington, United States
Countries
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Other Identifiers
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