Effect of HSV-2 Suppressive Therapy on Sexual Behavior

Study Overview
=================
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.

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

Conditions
-----------------
Genital Herpes

Intervention / Treatment
-----------------
* Drug: acyclovir
* Drug: acyclovir


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Episodic Treatment Arm<br>800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence | Drug: acyclovir<br>* 800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence<br>|
| Active Comparator: Suppressive Therapy Arm<br>400 mg acyclovir orally twice daily for 1 year | Drug: acyclovir<br>* 400 mg acyclovir orally twice daily for 1 year<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Effect of Suppressive Antiviral Therapy on Sexual Behavior Among HSV-2 Seropositive Persons With Multiple Sexual Partners. |  | 1 year |