HSV-2 Shedding Resolution After Acyclovir Treatment

Genital Herpes Clinical Trial

Official title:

Half-life and Pattern of Resolution of Herpes Simplex Virus Type 2 (HSV-2) Shedding After Beginning Acyclovir Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00495573
• Other study ID #: 26224-A
• Secondary ID: P01AI030731R01AI
• Status: Completed
• Phase: N/A
• First received: June 29, 2007
• Last updated: March 21, 2012
• Start date: June 2007
• Est. completion date: March 2012

Study information

• Verified date: March 2012
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2012
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Genital Herpes
• Herpes Genitalis

Intervention

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

Locations

Country	Name	City	State
United States	University of Washington Virology Research Clinic	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No