Effect of HSV-2 Suppressive Therapy on Sexual Behavior

NCT00495716 | Terminated Phase 4 Results

• 2 other identifiers: 32545K23AI071257-01A1
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Genital Herpes

Outcome Measures

Primary Outcomes (1)

• The Effect of Suppressive Antiviral Therapy on Sexual Behavior Among HSV-2 Seropositive Persons With Multiple Sexual Partners.

  1 year

Study Arms (2)

Episodic Treatment Arm

ACTIVE COMPARATOR

800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence

Drug: acyclovir

Suppressive Therapy Arm

ACTIVE COMPARATOR

400 mg acyclovir orally twice daily for 1 year

Drug: acyclovir

Interventions

acyclovir DRUG

800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence

Episodic Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• HSV-2 seropositive by Western blot OR documented culture positive for HSV-2 from anogenital site
• 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

You may not qualify if:

• Pregnancy or intention to become pregnant within the next year
• Suppressive therapy with acyclovir, valacyclovir, or famciclovir within 2 weeks of enrollment/randomization
• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

University of Washington Virology Research Clinic

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Herpes Genitalis

Interventions

Acyclovir

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Study terminated; investigator relocated and study funding ended. Results cannot be analyzed because data were not collected.

Results Point of Contact

• Title: Clinic Director
• Organization: University of Washington Virology Research Clinic

vrc@uw.edu

206-520-4340

Study Officials

• Anna Wald, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 29, 2007
• First Posted: July 3, 2007
• Study Start: January 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: March 7, 2023
• Results First Posted: January 29, 2020

Record last verified: 2023-02

Locations

US (1)