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 @ 7:55 PM
Ignite Modification Date:
2025-12-24 @ 7:55 PM
NCT ID:
NCT05334004
Eligibility Criteria:
Inclusion Criteria:
* willing to provide informed consent
* greater than or equal to 18 years of age
* Diagnosis of biopsy-confirmed HGAIN
* Human immunodeficiency virus (HIV)-positive with CD4 count greater than 200 cells/mm\^3 at screening and virologically suppressed on HIV-1 antiretroviral therapy (ART) within last 12 months
* willing to comply with all study procedures
Exclusion Criteria:
* Diagnosis of low-grade anal dysplasia (AIN, low-grade squamous intraepithelial lesion (LSIL)) by HRA.
* CD4 count less than 200 cells/mm\^3 at the time of consideration for entry into the study
* unable to provide informed consent
* Pregnant or breastfeeding female
* Currently receiving systemic chemotherapy or radiation therapy for another cancer.
* Have received topical therapy for anal dysplasia previously
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05334004
Study Brief:
Protocol Section:
NCT05334004