Overview

This trial is active, not recruiting.

Condition genital herpes
Treatments acyclovir
Phase phase 4
Sponsor University of Washington
Collaborator National Institute of Allergy and Infectious Diseases (NIAID)
Start date January 2008
End date July 2018
Trial size 72 participants
Trial identifier NCT00495716, 32545-B, K23AI071257-01A1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Arm
(Active Comparator)
800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence
acyclovir
800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence
(Active Comparator)
400 mg acyclovir orally twice daily for 1 year
acyclovir
400 mg acyclovir orally twice daily for 1 year

Primary Outcomes

Measure
To determine the effect of suppressive antiviral therapy on sexual behavior among HSV-2 seropositive persons with multiple sexual partners.
time frame: 1 year

Secondary Outcomes

Measure
To examine the acceptability and adherence to suppressive antiviral therapy for HSV-2 prevention among single, sexually active men and women.
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Effect of Suppressive Therapy on Behavioral Determinants of HSV-2 Transmission
Principal investigator Anna Wald, MD, MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by University of Washington.