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NCT06233331 · ClinicalTrials.gov registry record · Phase 1
Use of ACU-D1 in HPV Associated Vulvar and Perianal Lesions in People With HIV
A Phase 1 study, sponsored by Emory University.
- Not yet
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT06233331 is a Phase 1 study that has not yet begun recruiting, run by Emory University. The registered enrollment target is 9 participants.
The verdict
NCT06233331, a Phase 1 study, has not yet begun recruiting, sponsored by Emory University.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
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.
Interventions
- DRUG Dose Level 1 ACU-D1 ointment
- DRUG Dose Level 2 ACU-D1 ointment
- DRUG Dose Level 3 ACU-D1 ointment
- PROCEDURE Vulvar/ Perianal Biopsy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2026-06 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06233331
The ClinicalTrials.gov registry entry for NCT06233331 describes a study currently listed as not yet recruiting, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Dose Level 1 ACU-D1 ointment is the first listed.
NCT06233331 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06233331 about?
NCT06233331 is a clinical study titled "Use of ACU-D1 in HPV Associated Vulvar and Perianal Lesions in People With HIV". 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 induce...
What is the current status of trial NCT06233331?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2026-06. Estimated completion is 2027-12.
What interventions are being tested in trial NCT06233331?
The interventions under investigation include: Dose Level 1 ACU-D1 ointment (DRUG), Dose Level 2 ACU-D1 ointment (DRUG), Dose Level 3 ACU-D1 ointment (DRUG), Vulvar/ Perianal Biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT06233331?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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