Back to results

Effect of HSV-2 Suppressive Therapy on Sexual Behavior

Primary Purpose

Genital Herpes

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

acyclovir

About this trial

This is an interventional other trial for Genital Herpes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Washington Virology Research Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Episodic Treatment Arm

Suppressive Therapy Arm

Arm Description

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

400 mg acyclovir orally twice daily for 1 year

Outcomes

Primary Outcome Measures

The Effect of Suppressive Antiviral Therapy on Sexual Behavior Among HSV-2 Seropositive Persons With Multiple Sexual Partners.

Secondary Outcome Measures

Full Information

NCT ID

NCT00495716

First Posted

June 29, 2007

Last Updated

February 13, 2023

Sponsor

University of Washington

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

1. Study Identification

Unique Protocol Identification Number

NCT00495716

Brief Title

Effect of HSV-2 Suppressive Therapy on Sexual Behavior

Official Title

Effect of Suppressive Therapy on Behavioral Determinants of HSV-2 Transmission

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Terminated

Why Stopped

Investigator relocated and study funding ended.

Study Start Date

January 2008 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Washington

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Genital Herpes

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Episodic Treatment Arm

Arm Type

Active Comparator

Arm Description

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

Arm Title

Suppressive Therapy Arm

Arm Type

Active Comparator

Arm Description

400 mg acyclovir orally twice daily for 1 year

Intervention Type

Drug

Intervention Name(s)

acyclovir

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

acyclovir

Intervention Description

400 mg acyclovir orally twice daily for 1 year

Primary Outcome Measure Information:

Title

The Effect of Suppressive Antiviral Therapy on Sexual Behavior Among HSV-2 Seropositive Persons With Multiple Sexual Partners.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anna Wald, MD, MPH

Organizational Affiliation

University of Washington

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Washington Virology Research Clinic

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Effect of HSV-2 Suppressive Therapy on Sexual Behavior

We'll reach out to this number within 24 hrs