About this trial
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 criteria
Qualifiers
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
Disqualifiers
Currently pregnant (confirmed by collecting urine for HCG pregnancy test) or lactating
Trial design
Treatments tested in this trial
- Dose Level 1 ACU-D1 ointment
- Dose Level 2 ACU-D1 ointment
- Dose Level 3 ACU-D1 ointment
- Vulvar/ Perianal Biopsy
Treatment groups
Sponsors and collaborators
Emory University
Lead sponsor
Georgia Center for Oncology Research & Education
Collaborator