Effect of HSV-2 Suppressive Therapy on Sexual Behavior

Genital Herpes Clinical Trial

Official title:

Effect of Suppressive Therapy on Behavioral Determinants of HSV-2 Transmission

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00495716
• Other study ID #: 32545
• Secondary ID: K23AI071257-01A1
• Status: Terminated
• Phase: Phase 4
• Start date: January 2008
• Est. completion date: June 2010

Study information

• Verified date: February 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 72
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Genital Herpes
• Herpes Genitalis

Intervention

Drug:
• acyclovir
800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence
• acyclovir
400 mg acyclovir orally twice daily for 1 year

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Effect of Suppressive Antiviral Therapy on Sexual Behavior Among HSV-2 Seropositive Persons With Multiple Sexual Partners.		1 year