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Use of ACU-D1 in HPV Associated Vulvar and Perianal Lesions in People With HIV

Not Yet RecruitingPhase 1

Sponsor: Emory University

Conditions: Human Papilloma Virus, Human Immunodeficiency Virus, Anal Intraepithelial Neoplasia, High-Grade Squamous Intraepithelial Lesions

Interventions: Dose Level 1 ACU-D1 ointment, Dose Level 2 ACU-D1 ointment, Dose Level 3 ACU-D1 ointment, Vulvar/ Perianal Biopsy

Countries: United States

The goal of this study is to test the maximum tolerated dose of ACU-D1 in HIV-positive people with HPV-associated vulvar and perianal lesions. The main questions it aims to answer are: * The maximum tolerated dose of ACU-D1 * Safety and tolerability of topical ACU-D1 * Whether topical ACU-D1 induces p53 and p53-mediated downstream signaling (including p21 induction) in HPV-related lesions * Whether topical ACU-D1 enhances markers of immunity in HPV-infected HIV-positive individuals Participants will be asked * To apply ACU-D1 on the lesions twice daily for 4 weeks * 3 biopsies will be performed at the screening and 3 at the end of 4 weeks.

Eligibility overview

Sex: ALL

Age: 21 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Age 21 years and older
* HIV-infected
* Able to provide informed consent
* Biopsy-proven HSIL disease of the vulvar and perianal region with a total disease volume of 3 cm or greater
* Combined antiretrovirals (cART) adherence
* CD4 count \> 200 cells/ml
* Sustained undetectable viral load for ≥ 3 months
* If applicable, on reliable birth control such as combined oral contraceptive pills (OCP), bilateral tubal ligation (BTL), a long-acting reversible contraceptive, or Depo-Provera (birth control shot)
* Willingness to conform to study requirements
* Reliable follow-up and contact information
* No risk factors or clinical suspicion for micro-invasive disease and absence of medical condition that interferes with the conduct of the study in the investigator's opinion

Exclusion Criteria:

* Currently pregnant (confirmed by collecting urine for HCG pregnancy test) or lactating

Locations (1)

Atlanta, Georgia, United States