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Effect of HSV-2 Suppressive Therapy on Sexual Behavior

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ClinicalTrials.gov Identifier: NCT00495716
Recruitment Status : Terminated (Investigator relocated and study funding ended.)
First Posted : July 3, 2007
Results First Posted : January 29, 2020
Last Update Posted : January 29, 2020
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Anna Wald, University of Washington

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.

Condition or disease Intervention/treatment Phase
Genital Herpes Drug: acyclovir Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effect of Suppressive Therapy on Behavioral Determinants of HSV-2 Transmission
Study Start Date : January 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. The Effect of Suppressive Antiviral Therapy on Sexual Behavior Among HSV-2 Seropositive Persons With Multiple Sexual Partners. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. The Acceptability and Adherence to Suppressive Antiviral Therapy for HSV-2 Prevention Among Single, Sexually Active Men and Women. [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00495716

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United States, Washington
University of Washington Virology Research Clinic
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
National Institute of Allergy and Infectious Diseases (NIAID)
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Principal Investigator: Anna Wald, MD, MPH University of Washington
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Responsible Party: Anna Wald, Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT00495716    
Other Study ID Numbers: 32545
K23AI071257-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 3, 2007    Key Record Dates
Results First Posted: January 29, 2020
Last Update Posted: January 29, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Herpes Genitalis
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Communicable Diseases
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Antiviral Agents
Anti-Infective Agents