Effect of HSV-2 Suppressive Therapy on Sexual Behavior

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Anna Wald, University of Washington
ClinicalTrials.gov Identifier:
NCT00495716
First received: June 29, 2007
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Genital Herpes
Drug: acyclovir
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Effect of Suppressive Therapy on Behavioral Determinants of HSV-2 Transmission

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: January 2008
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Episodic Treatment Arm
800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence
Drug: acyclovir
800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence
Active Comparator: Suppressive Therapy Arm
400 mg acyclovir orally twice daily for 1 year
Drug: acyclovir
400 mg acyclovir orally twice daily for 1 year

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00495716

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: NCT00495716     History of Changes
Other Study ID Numbers: 32545-B, K23AI071257-01A1
Study First Received: June 29, 2007
Last Updated: June 3, 2014
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 August 28, 2014