Official Title: “Half-Life and Pattern of Resolution of Herpes Simplex Virus Type 2 (HSV-2) Shedding After Beginning Acyclovir Treatment”

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.

Study Type: Observational

Study Design: Case-Only, Prospective

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.

Intervention(s) in this Clinical Trial

• Drug: acyclovir
  • 400 mg acyclovir, orally three times a day for 5 days

Arms, Groups and Cohorts in this Clinical Trial

• : 1
  • HSV-2 seropositive subjects who will receive a 5-day course of acyclovir for treatment of a genital herpes recurrence.
• : 2
  • HSV-2 seropositive subjects who will be observed during a genital herpes recurrence but not receive acyclovir.

Primary Measures

• 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.
  • Time Frame: 5 days
    Safety Issue?: No

Secondary Measures

• 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.
  • Time Frame: 5 days
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Washington

Overall Clinical Trial Officials and Contacts

Karen Mark, MD, MPH Principal Investigator University of Washington  

Overall Contact: Karen Mark, MD, MPH 206-720-4340 kmark@u.washington.edu

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00495573

Study ID Number: 26224

ClinicalTrials.gov Identifier: NCT00495573

Health Authority: United States: Institutional Review Board