Clinical Trials Directory

Trials / Terminated

TerminatedNCT00495716

Effect of HSV-2 Suppressive Therapy on Sexual Behavior

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

Status
Terminated
Phase
Phase 4
Study type
Interventional
Enrollment
72 (actual)
Sponsor
University of Washington · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGacyclovir800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence
DRUGacyclovir400 mg acyclovir orally twice daily for 1 year

Timeline

Start date
2008-01-01
Primary completion
2010-06-01
Completion
2010-06-01
First posted
2007-07-03
Last updated
2023-03-07
Results posted
2020-01-29

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00495716. Inclusion in this directory is not an endorsement.