HSV-2 Shedding Resolution After Acyclovir Treatment
Information source: University of Washington
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Genital Herpes
Intervention: acyclovir (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Washington Official(s) and/or principal investigator(s):
Karen Mark, MD, MPH, Principal Investigator, Affiliation: University of Washington
Overall contact:
Karen Mark, MD, MPH, Phone: 206-720-4340, Email: kmark@u.washington.edu
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.
Clinical Details
Official title: Half-Life and Pattern of Resolution of Herpes Simplex Virus Type 2 (HSV-2) Shedding After Beginning Acyclovir Treatment
Study design: Case-Only, Prospective
Primary outcome: 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.
Secondary outcome: 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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Karen Mark, MD, MPH, Phone: 206-720-4340, Email: kmark@u.washington.edu
University of Washington Virology Research Clinic, Seattle, Washington 98122, United States; Recruiting
Selin Caka, Phone: 206-720-4340, Email: scaka@u.washington.edu
Karen Mark, MD, MPH, Principal Investigator
Additional Information
Starting date: June 2007
Ending date: July 2017
Last updated: June 16, 2009
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