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
| Type | Name | Description |
|---|---|---|
| DRUG | acyclovir | 800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence |
| DRUG | acyclovir | 400 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.