Effect of HSV-2 Suppressive Therapy on Sexual Behavior

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.

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