NCT06233331Not yet recruitingPhase 1
Use of ACU-D1 in HPV Associated Vulvar and Perianal Lesions in People With HIV
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
Source: ClinicalTrials.gov · Last updated 18 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (estimated)
- First submitted
- 22 Jan 2024
- Start date
- Dec 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- Emory University
- Diseases
- HIV
- NCT number
- NCT06233331
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 9
- From Dec 2026 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Currently pregnant (confirmed by collecting urine for HCG pregnancy test) or lactating
Who the study is looking for
- 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
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Grady Memorial Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.