Eligibility Module

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 @ 9:33 PM
Ignite Modification Date: 2025-12-24 @ 9:33 PM
NCT ID: NCT00076232
Eligibility Criteria: Inclusion Criteria For All Participants: * HIV-uninfected * HSV-2 infected * Plans to stay in the area for the duration of study participation * Willing and able to provide consent, undergo clinical evaluations, take study drugs, adhere to follow-up schedule, and provide adequate locator information Inclusion Criteria for MSM: * At least 1 episode of anal intercourse with another man within 6 months of study entry Inclusion Criteria for WSM: * At least 1 episode of unprotected vaginal sex within 6 months of study entry Exclusion Criteria For All Participants: * Current enrollment in another HIV vaccine or prevention trial * History of adverse reaction to acyclovir * Current or planned use of famiciclovir, valacyclovir, or acyclovir for genital HSV. Use of short-course antiviral therapy for herpes zoster after enrollment is allowed. * Known plans for travel away from study site for more than 2 months Exclusion Criteria for MSM: * In a mutually monogamous relationship with an HIV uninfected partner throughout the past 2 years * Reported sex at birth as female Exclusion Criteria for WSM: * Pregnancy at screening or enrollment
Healthy Volunteers: False
Sex: ALL
Study: NCT00076232
Study Brief:
Protocol Section: NCT00076232