Effect of HSV-2 Suppressive Therapy on Sexual Behavior

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University of Washington

Status and phase

Terminated
Phase 4

Conditions

Genital Herpes

Treatments

Drug: acyclovir

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00495716
K23AI071257-01A1 (U.S. NIH Grant/Contract)
32545

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

72 participants in 2 patient groups

Episodic Treatment Arm
Active Comparator group
Description:
800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence
Treatment:
Drug: acyclovir
Suppressive Therapy Arm
Active Comparator group
Description:
400 mg acyclovir orally twice daily for 1 year
Treatment:
Drug: acyclovir

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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