Ignite Creation Date:
2025-12-26 @ 11:45 AM
Ignite Modification Date:
2025-12-31 @ 11:32 AM
Study NCT ID:
NCT00495716
Status:
TERMINATED
Last Update Posted:
2023-03-07
First Post:
2007-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of HSV-2 Suppressive Therapy on Sexual Behavior
Sponsor:
University of Washington
Organization:
Study Overview
Official Title:
Effect of Suppressive Therapy on Behavioral Determinants of HSV-2 Transmission
Status:
TERMINATED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Investigator relocated and study funding ended.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| K23AI071257-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |