Genital Herpes
Conditions
Brief summary
The purpose of the study is to evaluate the pattern of viral shedding after beginning treatment with acyclovir for a clinical recurrence of genital herpes and to compare it with the pattern of viral shedding during an untreated clinical recurrence of genital herpes.
Detailed description
The purpose of the study is to evaluate the pattern of viral shedding after beginning treatment with acyclovir for a clinical recurrence of genital herpes and to compare it with the pattern of viral shedding during an untreated clinical recurrence of genital herpes. 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.
Interventions
DRUGacyclovir
400 mg acyclovir, orally three times a day for 5 days
Sponsors
National Institutes of Health (NIH)
University of Washington
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * 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
* Pregnancy * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To calculate the half-life of detectable HSV-2 DNA in genital mucosa during a clinical recurrence of genital herpes, after treatment with acyclovir has begun. | 5 days |
Secondary
| Measure | Time frame |
|---|---|
| To describe the time course, diurnal variation, and pattern of resolution of HSV-2 shedding during both acyclovir-treated and untreated clinical recurrences of genital herpes. | 5 days |
Countries
United States
Outcome results
None listed