drugset / Trial / NCT06233331
Use of ACU-D1 in HPV Associated Vulvar and Perianal Lesions in People With HIV
Phase 1
Not yet recruiting
9 enrolled
Emory University
Georgia Center for Oncology Research & Education · collab
Non-randomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2026-06
- Primary completion
- 2027-12
- Completion
- 2027-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionate) | Unknown | 2.5 % | Topical |
| Subject | pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionate) | Unknown | 5 % | Topical |
| Subject | pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionate) | Unknown | 10 % | Topical |