Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Intraepithelial Neoplasia | Anal Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| High-Grade Squamous Intraepithelial Lesions | — | UNRESOLVED | — |
| Human Immunodeficiency Virus | — | UNRESOLVED | — |
| Human Papilloma Virus | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dose Level 1 ACU-D1 ointment | Drug | — | UNRESOLVED |
| Dose Level 2 ACU-D1 ointment | Drug | — | UNRESOLVED |
| Dose Level 3 ACU-D1 ointment | Drug | — | UNRESOLVED |
| Vulvar/ Perianal Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Level 1
- description
- Initial three study participants will be enrolled in Dose Level 1, 2.5% ACU-D1 twice daily for 4 weeks.
- interventionNames
- Drug: Dose Level 1 ACU-D1 ointment
- Procedure: Vulvar/ Perianal Biopsy
- type
- EXPERIMENTAL
- label
- Level 2
- description
- If there are no DLTs to Dose Level 1 then, 3 new study participants will proceed to Dose Level 2 at 5% ACU-D1.
- interventionNames
- Drug: Dose Level 2 ACU-D1 ointment
- Procedure: Vulvar/ Perianal Biopsy
- type
- EXPERIMENTAL
- label
- Level 3
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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 Exclusion Criteria: * Currently pregnant (confirmed by collecting urine for HCG pregnancy test) or lactating
References
Publications (0)
Data not yet available