Use of ACU-D1 in HPV Associated Vulvar and Perianal Lesions in People With HIV
Starting soon · Phase 1
Conditions studied: Human Papilloma Virus, Human Immunodeficiency Virus, Anal Intraepithelial Neoplasia, High-Grade Squamous Intraepithelial Lesions
In brief
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.
Key facts
- Study ID
- NCT06233331
- Run by
- Emory University
- People needed
- 9
- Starts
- 2026-06-01
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-05-08
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Currently pregnant (confirmed by collecting urine for HCG pregnancy test) or lactating
Where it is running
- Grady Memorial Hospital — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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