Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT06233331

Not Yet Recruiting

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

Interventional

Phase 1

Grady Memorial Hospital

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.

Show Detailed Description

Treatment Category

Other Drugs, Procedure

Required Mutations

None

Trial Started

2025-11-07

Last Updated by Sponsor

2025-08-06

Estimated Completion

2026-12-01

Eligibility

Inclusion Criteria

* 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

* Combined antiretrovirals (cART) adherence

* CD4 count > 200 cells/ml

* Sustained undetectable viral load for ≥ 3 months

* If applicable, on reliable birth control such as combined oral contraceptive pills (OCP), bilateral tubal ligation (BTL), a long-acting reversible contraceptive, or Depo-Provera (birth control shot)

* Willingness to conform to study requirements

* Reliable follow-up and contact information

* No risk factors or clinical suspicion for micro-invasive disease and absence of medical condition that interferes with the conduct of the study in the investigator's opinion

* Currently pregnant (confirmed by collecting urine for HCG pregnancy test) or lactating

Exclusion Criteria

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Design Details

AllocationNon-Randomized

Intervention ModelSequential Assignment

MaskingNone (Open Label)

Number to Enroll9

Arms & Interventions

Arms

Interventions

Type: Experimental

Description: Initial three study participants will be enrolled in Dose Level 1, 2.5% ACU-D1 twice daily for 4 weeks.

Interventions:

Dose Level 1 ACU-D1 ointment
Dose Level 2 ACU-D1 ointment
Dose Level 3 ACU-D1 ointment
Vulvar/ Perianal Biopsy

Outcome Measures

Primary Outcome Measures

Maximum tolerated dose (MTD) of ACU-D1Baseline, week 4

Subjects will be monitored during the trial for adverse events, tolerability and compliance using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. The dose level at which no more than 33% of study participants have a DLT will be considered the maximum tolerated dose.

Secondary Outcome Measures

Ability of ACU-D1 to induce p53 and p21 in HPV lesionsBaseline, week 4

The biopsies collected at the the 1st study visit and at the last study visit (week 4) mark will be examined using immunohistochemistry to determine gene activity and be used for other biomolecular assays

Safety of ACU-D1: Time of maximum observed concentration (tmax)Before ointment application (0hr), 0.25 hour, 0.50 hour, 1hour, 1.5 hour, 2 hour, 4, 8 hour and 12 hour

Pharmacokinetic studies will be performed on 3 participants after the 4th week of 10% ACU-D1 ointment application. As part of the studies, these 3 subjects will be admitted to the Grady satellite of the Atlanta Clinical and Translational Science Institute (ACTSI) where blood and urine samples will be collected in quick succession.

Safety of ACU-D1: Maximum concentration (Cmax)Before ointment application (0hr), 0.25 hour, 0.50 hour, 1hour, 1.5 hour, 2 hour, 4, 8 hour and 12 hour

Safety of ACU-D1: Area under the concentration-time curve for the last measurable concentration (AUC0-last)Before ointment application (0hr), 0.25 hour, 0.50 hour, 1hour, 1.5 hour, 2 hour, 4, 8 hour and 12 hour