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

NCT06233331 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

  • Human Papilloma Virus
  • Human Immunodeficiency Virus
  • Anal Intraepithelial Neoplasia
  • High-Grade Squamous Intraepithelial Lesions

Interventions

PROCEDURE

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).

DRUG

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.

DRUG

Dose Level 2 ACU-D1 ointment

Level 2 will consist of 5% ACU-D1 ointment, used twice daily for 4 weeks.

DRUG

Dose Level 3 ACU-D1 ointment

Level 3 will consist of 10% ACU-D1 ointment, used twice daily for 4 weeks.

Sponsors & Collaborators

  • Georgia Center for Oncology Research & Education

    collaborator OTHER

  • Emory University

    lead OTHER

Principal Investigators

  • Lisa Flowers, MD, MPH · Emory University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06233331 on ClinicalTrials.gov