Effect of HSV-2 Suppressive Therapy on Sexual Behavior
Primary Purpose
Genital Herpes
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
acyclovir
acyclovir
Sponsored by
About this trial
This is an interventional other trial for Genital Herpes
Eligibility Criteria
Inclusion Criteria:
- Age 18 years or older
- HSV-2 seropositive by Western blot OR documented culture positive for HSV-2 from anogenital site
- 2 or more vaginal or anal sex partners in the past 12 months
- Not currently in a monogamous sexual relationship of >= 6 months duration
- Willing and able to be randomized and comply with the study protocol
Exclusion Criteria:
- Pregnancy or intention to become pregnant within the next year
- Suppressive therapy with acyclovir, valacyclovir, or famciclovir within 2 weeks of enrollment/randomization
- 6 or more symptomatic herpes recurrences in the prior 12 months or in the 12 months prior to starting suppressive therapy if on suppressive therapy during the prior 12 months
- HIV seropositive or known immunocompromising medical condition. HIV negative test must be performed within 60 days of Visit 1 (enrollment/randomization). For current or former participants in HIV vaccine clinical trials for whom HIV vaccine-induced seropositivity potentially leading to vaccine study unblinding may be a concern, a report from the Seattle HVTU documenting that the participant is HIV uninfected based on HIV testing done within 60 days of Visit 1 will be accepted in lieu of HIV testing done at our clinic.
- Intention to move from the Seattle area within the next year
- Known allergy, intolerance, or medical contraindication to acyclovir
- Inability to understand, speak, and read English
Sites / Locations
- University of Washington Virology Research Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Episodic Treatment Arm
Suppressive Therapy Arm
Arm Description
800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence
400 mg acyclovir orally twice daily for 1 year
Outcomes
Primary Outcome Measures
The Effect of Suppressive Antiviral Therapy on Sexual Behavior Among HSV-2 Seropositive Persons With Multiple Sexual Partners.
Secondary Outcome Measures
Full Information
NCT ID
NCT00495716
First Posted
June 29, 2007
Last Updated
February 13, 2023
Sponsor
University of Washington
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00495716
Brief Title
Effect of HSV-2 Suppressive Therapy on Sexual Behavior
Official Title
Effect of Suppressive Therapy on Behavioral Determinants of HSV-2 Transmission
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
Investigator relocated and study funding ended.
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine what effect suppressive therapy has on sexual behavior and quality of life among persons with genital herpes (HSV) who have multiple sex partners.
Study terminated; investigator relocated and study funding ended. Results were never analyzed because data were not collected.
Detailed Description
We plan to conduct a randomized controlled trial of chronic suppressive acyclovir, 400 mg orally twice daily (standard dose) versus episodic acyclovir for treatment of genital herpes recurrences. We will enroll 500 HSV-2 seropositive single persons (250 per arm), stratified by gender and history of symptomatic genital herpes, and prospectively follow them for 1 year to assess sexual behavior, adherence to therapy, and herpes-related quality of life. These outcomes will be measured by self-report in a confidential, computer-based assessment. We plan to use data from this trial to model the effect that increasing the proportion of sexually-active HSV-2 infected persons taking suppressive therapy will have on population-level incidence and prevalence of HSV-2.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Herpes
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Episodic Treatment Arm
Arm Type
Active Comparator
Arm Description
800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence
Arm Title
Suppressive Therapy Arm
Arm Type
Active Comparator
Arm Description
400 mg acyclovir orally twice daily for 1 year
Intervention Type
Drug
Intervention Name(s)
acyclovir
Intervention Description
800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence
Intervention Type
Drug
Intervention Name(s)
acyclovir
Intervention Description
400 mg acyclovir orally twice daily for 1 year
Primary Outcome Measure Information:
Title
The Effect of Suppressive Antiviral Therapy on Sexual Behavior Among HSV-2 Seropositive Persons With Multiple Sexual Partners.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 years or older
HSV-2 seropositive by Western blot OR documented culture positive for HSV-2 from anogenital site
2 or more vaginal or anal sex partners in the past 12 months
Not currently in a monogamous sexual relationship of >= 6 months duration
Willing and able to be randomized and comply with the study protocol
Exclusion Criteria:
Pregnancy or intention to become pregnant within the next year
Suppressive therapy with acyclovir, valacyclovir, or famciclovir within 2 weeks of enrollment/randomization
6 or more symptomatic herpes recurrences in the prior 12 months or in the 12 months prior to starting suppressive therapy if on suppressive therapy during the prior 12 months
HIV seropositive or known immunocompromising medical condition. HIV negative test must be performed within 60 days of Visit 1 (enrollment/randomization). For current or former participants in HIV vaccine clinical trials for whom HIV vaccine-induced seropositivity potentially leading to vaccine study unblinding may be a concern, a report from the Seattle HVTU documenting that the participant is HIV uninfected based on HIV testing done within 60 days of Visit 1 will be accepted in lieu of HIV testing done at our clinic.
Intention to move from the Seattle area within the next year
Known allergy, intolerance, or medical contraindication to acyclovir
Inability to understand, speak, and read English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Wald, MD, MPH
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington Virology Research Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of HSV-2 Suppressive Therapy on Sexual Behavior
We'll reach out to this number within 24 hrs