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Use of ACU-D1 in HPV Associated Vulvar and Perianal Lesions in People With HIV
Sponsor: Emory University
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.
Official title: Phase I Dose Escalation Study of the Use of ACU-D1, a Topical Proteasome Inhibitor in HPV Associated Vulvar and Perianal Lesions in People With HIV
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
9
Start Date
2025-11
Completion Date
2026-12
Last Updated
2025-08-06
Healthy Volunteers
No
Conditions
Interventions
Dose Level 1 ACU-D1 ointment
ACU-D1 is a topical therapeutic agent that has pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionate) (PTTC) as its major active ingredient. PTTC is a novel proteasome inhibitor that has antiangiogenic and anti-inflammatory activities that reduce pro-inflammatory cytokines. ACU-D1 ointment contains a range of 2.5% to 10% weight by volume of PTTC. Level 1 will consist of 2.5% ACU-D1 ointment, used twice daily for 4 weeks.
Dose Level 2 ACU-D1 ointment
Level 2 will consist of 5% ACU-D1 ointment, used twice daily for 4 weeks.
Dose Level 3 ACU-D1 ointment
Level 3 will consist of 10% ACU-D1 ointment, used twice daily for 4 weeks.
Vulvar/ Perianal Biopsy
3 vulvar or perianal biopsies are to be performed at the screening as well as at the end of the study (week 4).
Locations (1)
Grady Memorial Hospital
Atlanta, Georgia, United States