HSV-2 Shedding Resolution After Acyclovir Treatment

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 Overview

• Status: Completed
• Conditions: Genital Herpes
• Intervention / Treatment: Drug: acyclovir

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.

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington Virology Research Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HSV-2 seropositive men and women with a history of at least 3 clinical recurrences of genital herpes within the year prior to the screening visit. Participants will be recruited from the community.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; HSV-2 seropositive subjects who will receive a 5-day course of acyclovir for treatment of a genital herpes recurrence.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: June 29, 2007
• First Submitted That Met QC Criteria: July 2, 2007
• First Posted (Estimate): July 3, 2007

Study Record Updates

• Last Update Posted (Estimate): March 22, 2012
• Last Update Submitted That Met QC Criteria: March 21, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Herpesviridae Infections; Herpes Simplex; Herpes Genitalis; Anti-Infective Agents; Antiviral Agents; Acyclovir
• Other Study ID Numbers: 26224-A; P01AI030731 (U.S. NIH Grant/Contract); R01AI050132 (U.S. NIH Grant/Contract)