Use of ACU-D1 in HPV Associated Vulvar and Perianal Lesions in People With HIV
Status:
NOT_YET_RECRUITING
Trial end date:
2026-12-01
Target enrollment:
Participant gender:
Summary
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.