Trial record 5 of 6 for:
NIAID | herpes genitalis
Effect of HSV-2 Suppressive Therapy on Sexual Behavior
This study is ongoing, but not recruiting participants.
Sponsor:
University of Washington
Collaborator:
Information provided by (Responsible Party):
Anna Wald, University of Washington
ClinicalTrials.gov Identifier:
NCT00495716
First received: June 29, 2007
Last updated: March 14, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Genital Herpes |
Drug: acyclovir |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | Effect of Suppressive Therapy on Behavioral Determinants of HSV-2 Transmission |
Resource links provided by NLM:
Further study details as provided by University of Washington:
Primary Outcome Measures:
- To determine the effect of suppressive antiviral therapy on sexual behavior among HSV-2 seropositive persons with multiple sexual partners. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 500 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Episodic Treatment Arm
800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence
|
Drug: acyclovir
800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence
|
|
Active Comparator: Suppressive Therapy Arm
400 mg acyclovir orally twice daily for 1 year
|
Drug: acyclovir
400 mg acyclovir orally twice daily for 1 year
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00495716
Locations
| United States, Washington | |
| University of Washington Virology Research Clinic | |
| Seattle, Washington, United States, 98104 | |
Sponsors and Collaborators
University of Washington
Investigators
| Principal Investigator: | Anna Wald, MD, MPH | University of Washington |
More Information
No publications provided
| Responsible Party: | Anna Wald, Principal Investigator, University of Washington |
| ClinicalTrials.gov Identifier: | NCT00495716 History of Changes |
| Other Study ID Numbers: | 32545-B, K23AI071257-01A1 |
| Study First Received: | June 29, 2007 |
| Last Updated: | March 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Herpes Genitalis Herpes Simplex Herpesviridae Infections DNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Genital Diseases, Male Genital Diseases, Female Acyclovir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013