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:
2025-12-24 @ 1:34 PM
Ignite Modification Date:
2025-12-24 @ 1:34 PM
NCT ID:
NCT01687595
Eligibility Criteria:
Inclusion Criteria:
* Seropositive for herpes simplex virus type 2 (HSV-2)
* Clinically active genital herpes defined as a history of 1-9 episodes per year for at least 1 year prior to screening or 1 year prior to beginning suppressive therapy.
* Willing to either use an effective method of contraception or abstain from sexual intercourse throughout the 48-week study period.
* If female of childbearing potential, have a negative serum pregnancy test.
* Agree to not receive any other investigational drugs while enrolled in this study.
* The above criteria must be met before participants are allowed to enter the 45-day swabbing period to be screen for the study.
* Completion and collection of greater than or equal to 80% (36 days) of the 45-day consecutive daily genital swabs.
Exclusion Criteria:
* Severe active infection, compromised cardiopulmonary function, or other serious medical illness that, in the opinion of the principal investigator, would prevent study completion.
* A history of herpes simplex virus (HSV) infection of the eye (herpes simplex interstitial keratitis or uveitis), or herpes-associated erythema multiforme.
* A history of immune suppression or autoimmune disorder.
* Continued use of suppressive anti-viral therapy for HSV-2; a 1 week washout of any anti-viral therapy (suppressive and episodic) is required prior to initiating the swabbing period.
* Concomitant use of systemic corticosteroids or immune-suppressive medications. The use of nasal steroids is acceptable.
* Human immunodeficiency virus (HIV) positive.
* Presence of active Hepatitis B or C infection.
* Known hypersensitivity or allergies to acyclovir or valacyclovir.
* Pregnant or breast-feeding women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01687595
Study Brief:
Protocol Section:
NCT01687595