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Virus Therapy

Level 1 for Squamous Intraepithelial Lesion

Phase 1

Waitlist Available

Led By Lisa Flowers, MD, MPH

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 21 years and older

Biopsy-proven HSIL disease of the vulvar and perianal region with a total disease volume of 3 cm or greater

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before ointment application (0hr), 0.25 hour, 0.50 hour, 1hour, 1.5 hour, 2 hour, 4, 8 hour and 12 hour

Awards & highlights

Study Summary

This trial is testing a drug called ACU-D1 in people who have HIV and HPV-related vulvar and perianal lesions. The main goals of the study are to determine the highest dose of

Who is the study for?

This trial is for HIV-positive individuals with HPV-related vulvar or perianal lesions. Participants will apply a topical ointment called ACU-D1 and undergo biopsies before and after treatment to assess the drug's effects on their condition.Check my eligibility

What is being tested?

The study aims to find out the highest dose of ACU-D1 that patients can tolerate without severe side effects, its safety, how well it works in activating certain proteins (p53) against HPV in lesions, and if it boosts immunity in those infected with both HIV and HPV.See study design

What are the potential side effects?

Potential side effects from using ACU-D1 may include local skin reactions at the application site such as redness, itching or irritation. Systemic side effects are not detailed but could be related to immune response changes due to p53 activation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 21 years old or older.

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I have a confirmed severe skin condition in the genital or anal area, larger than 3 cm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before ointment application (0hr), 0.25 hour, 0.50 hour, 1hour, 1.5 hour, 2 hour, 4, 8 hour and 12 hour

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before ointment application (0hr), 0.25 hour, 0.50 hour, 1hour, 1.5 hour, 2 hour, 4, 8 hour and 12 hour

This trial's timeline: 3 weeks for screening, Varies for treatment, and before ointment application (0hr), 0.25 hour, 0.50 hour, 1hour, 1.5 hour, 2 hour, 4, 8 hour and 12 hour for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum tolerated dose (MTD) of ACU-D1

Secondary outcome measures

Ability of ACU-D1 to induce p53 and p21 in HPV lesions

Safety of ACU-D1: Area under the concentration-time curve for the last measurable concentration (AUC0-last)

Safety of ACU-D1: Maximum concentration (Cmax)

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Level 3Experimental Treatment2 Interventions

If there are no DLTs to Dose Level 2 then, 3 new study participants will proceed to Dose Level 3 at 10 % ACU-D1.

Group II: Level 2Experimental Treatment2 Interventions

If there are no DLTs to Dose Level 1 then, 3 new study participants will proceed to Dose Level 2 at 5% ACU-D1.

Group III: Level 1Experimental Treatment2 Interventions

Initial three study participants will be enrolled in Dose Level 1, 2.5% ACU-D1 twice daily for 4 weeks.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Georgia Center For Oncology Research and EducationUNKNOWN

Emory UniversityLead Sponsor

1,636 Previous Clinical Trials

2,560,564 Total Patients Enrolled

Lisa Flowers, MD, MPHPrincipal InvestigatorEmory University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the level of safety provided by Level 2 in terms of human well-being?

"Our team at Power has assigned a safety rating of 1 to Level 2. This is mainly due to the fact that this trial falls under Phase 1, where there is limited data available supporting both safety and efficacy."

Answered by AI

Are there any available openings for patients to participate in this medical study?

"Based on the information provided by clinicaltrials.gov, this specific trial is not currently accepting new participants. The trial was initially posted on March 1st, 2024 and underwent its most recent revision on January 30th, 2024. However, it's worth noting that there are presently 3157 other ongoing clinical trials actively seeking candidates for participation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Use of ACU-D1 in HPV Associated Vulvar and Perianal Lesions in People With HIV

Lisa Flowers 2024. "Use of ACU-D1 in HPV Associated Vulvar and Perianal Lesions in People With HIV". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06233331.

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