Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:45 AM
Ignite Modification Date:
2025-12-26 @ 11:45 AM
NCT ID:
NCT00495716
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00495716
Study Brief:
Protocol Section:
NCT00495716