ACU-D1 Ointment for HPV Lesions in People with HIV
What You Need to Know Before You Apply
What is the purpose of this trial?
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 individualsParticipants 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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it does require adherence to combined antiretrovirals (cART) for HIV, so you should continue those medications.
How is the drug ACU-D1 ointment different from other treatments for HPV lesions in people with HIV?
ACU-D1 ointment is unique because it is specifically formulated for HPV lesions in people with HIV, potentially offering a novel approach compared to existing treatments like topical cidofovir and imiquimod, which are used for similar conditions but may not be specifically tailored for this patient group.12345
What data supports the effectiveness of the drug ACU-D1 for treating HPV lesions in people with HIV?
Who Is on the Research Team?
Lisa Flowers, MD, MPH
Principal Investigator
Emory University
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants apply ACU-D1 on the lesions twice daily for 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ACU-D1
Find a Clinic Near You
Who Is Running the Clinical Trial?
Emory University
Lead Sponsor
Georgia Center for Oncology Research & Education
Collaborator
Georgia Center For Oncology Research and Education
Collaborator