Effect of HSV-2 Suppressive Therapy on Sexual Behavior

NCT ID: NCT00495716

Last Updated: 2023-03-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2010-06-30

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.

Study terminated; investigator relocated and study funding ended. Results were never analyzed because data were not collected.

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.

Conditions

Genital Herpes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Episodic Treatment Arm

800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence

Group Type: ACTIVE_COMPARATOR

acyclovir

Intervention Type: DRUG

800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence

Suppressive Therapy Arm

400 mg acyclovir orally twice daily for 1 year

Group Type: ACTIVE_COMPARATOR

acyclovir

Intervention Type: DRUG

400 mg acyclovir orally twice daily for 1 year

Interventions

acyclovir

800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence

Intervention Type: DRUG

acyclovir

400 mg acyclovir orally twice daily for 1 year

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Anna Wald

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna Wald, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington Virology Research Clinic

Seattle, Washington, United States

Countries

United States

Other Identifiers

K23AI071257-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

32545

Identifier Type: -

Identifier Source: org_study_id