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Effect of HSV-2 Suppressive Therapy on Sexual Behavior

Information source: University of Washington
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Genital Herpes

Intervention: acyclovir (Drug); acyclovir (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: University of Washington

Official(s) and/or principal investigator(s):
Anna Wald, MD, MPH, Principal Investigator, Affiliation: University of Washington

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.

Clinical Details

Official title: Effect of Suppressive Therapy on Behavioral Determinants of HSV-2 Transmission

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome: To determine the effect of suppressive antiviral therapy on sexual behavior among HSV-2 seropositive persons with multiple sexual partners.

Secondary outcome: To examine the acceptability and adherence to suppressive antiviral therapy for HSV-2 prevention among single, sexually active men and women.

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

University of Washington Virology Research Clinic, Seattle, Washington 98104, United States
Additional Information

Starting date: January 2008
Last updated: July 2, 2015

Page last updated: August 23, 2015

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