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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: Clinical Trial Phase 1 study, sponsored by Emory University.
NCT06233331 is a Phase 1 study that has not yet begun recruiting, run by Emory University. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What is known before NCT06233331 opens enrollment
NCT06233331 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 4 interventions - of which Dose Level 1 ACU-D1 ointment is the first listed.
NCT06233331 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06233331's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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