Your session is about to expire
← Back to Search
Virus Therapy
ACU-D1 Ointment for HPV Lesions in People with HIV
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
No Placebo-Only Group
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.
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.
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 belowSelect...
I am 21 years old or older.
Select...
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum tolerated dose (MTD) of ACU-D1
Secondary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Find a Location
Who is running the clinical trial?
Georgia Center for Oncology Research & EducationOTHER
2 Previous Clinical Trials
151 Total Patients Enrolled
Georgia Center For Oncology Research and EducationUNKNOWN
Emory UniversityLead Sponsor
1,704 Previous Clinical Trials
2,607,289 Total Patients Enrolled
Lisa Flowers, MD, MPHPrincipal InvestigatorEmory University
2 Previous Clinical Trials
548 Total Patients Enrolled