Genital Herpes
Conditions
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.
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.
Interventions
DRUGacyclovir
800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Effect of Suppressive Antiviral Therapy on Sexual Behavior Among HSV-2 Seropositive Persons With Multiple Sexual Partners. | 1 year |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Episodic Treatment Arm 800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence
acyclovir: 800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence | 35 |
| Suppressive Therapy Arm 400 mg acyclovir orally twice daily for 1 year
acyclovir: 400 mg acyclovir orally twice daily for 1 year | 37 |
| Total | 72 |
Baseline characteristics
| Characteristic | Suppressive Therapy Arm | Total | Episodic Treatment Arm |
|---|---|---|---|
| Age, Continuous | 39 years | 39 years | 40 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 24 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 46 Participants | 21 Participants |
| Sex: Female, Male Female | 15 Participants | 29 Participants | 14 Participants |
| Sex: Female, Male Male | 22 Participants | 43 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 35 | 0 / 37 |
| serious Total, serious adverse events | 0 / 35 | 0 / 37 |
Outcome results
Primary
The Effect of Suppressive Antiviral Therapy on Sexual Behavior Among HSV-2 Seropositive Persons With Multiple Sexual Partners.
Time frame: 1 year
Population: Study terminated; investigator relocated and study funding ended. Results cannot be analyzed because data were not collected.