Official Title: “Effect of Suppressive Therapy on Behavioral Determinants of HSV-2 Transmission”

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 Type: Interventional

Study Design: Other, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: September 2012

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Episodic Treatment Arm
• Active Comparator: 2
  • Suppressive Therapy Arm

Primary Measures

• To determine the effect of suppressive antiviral therapy on sexual behavior among HSV-2 seropositive persons with multiple sexual partners.
  • Time Frame: 1 year
    Safety Issue?: No

Secondary Measures

• To examine the acceptability and adherence to suppressive antiviral therapy for HSV-2 prevention among single, sexually active men and women.
  • Time Frame: 1 year
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Washington

Overall Clinical Trial Officials and Contacts

Karen Mark, MD, MPH Principal Investigator University of Washington  

Overall Contact: Karen Mark, MD, MPH 206-720-4340 suppression@u.washington.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00495716

Study ID Number: 32545-B

ClinicalTrials.gov Identifier: NCT00495716

Health Authority: United States: Institutional Review Board