HSV-2 Shedding Resolution After Acyclovir Treatment

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Anna Wald, University of Washington
ClinicalTrials.gov Identifier:
NCT00495573
First received: June 29, 2007
Last updated: March 21, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Genital Herpes
Drug: acyclovir

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Half-life and Pattern of Resolution of Herpes Simplex Virus Type 2 (HSV-2) Shedding After Beginning Acyclovir Treatment

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood, genital swab specimens


Enrollment: 36
Study Start Date: June 2007
Study Completion Date: March 2012
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00495573

Locations
United States, Washington
University of Washington Virology Research Clinic
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Anna Wald, MD, MPH University of Washington
  More Information

No publications provided

Responsible Party: Anna Wald, Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT00495573     History of Changes
Other Study ID Numbers: 26224-A, P01 AI-30731, R01 AI050132
Study First Received: June 29, 2007
Last Updated: March 21, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Herpes Genitalis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014