ACU-D1 Ointment for HPV Lesions in People with HIV

Overseen By Lisa Flowers, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Emory University

Must be taking: Combined antiretrovirals

Disqualifiers: Pregnancy, Lactation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new ointment, ACU-D1, for individuals with HIV who have certain HPV-related lesions in the vulvar and perianal areas. The main goal is to determine the safest dose and assess whether the ointment can trigger beneficial immune responses in these lesions. Participants will apply the ointment twice daily for four weeks and undergo biopsies before and after treatment. This trial suits HIV-positive individuals who have these specific lesions and have managed their HIV with stable treatment. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that ACU-D1 ointment is likely to be safe for humans?

Research has shown that ACU-D1 ointment is generally safe and well-tolerated. Studies have found that it can help reduce skin inflammation, indicating its potential effectiveness. Researchers are testing this treatment in people with HIV and HPV-related skin issues. The study aims to find the highest dose that can be used without causing serious side effects. Participants will apply the ointment twice a day for four weeks. Although specific side effects have not been listed, the study focuses on ensuring safety and determining the most effective dose. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

ACU-D1 is unique because it offers a topical approach to treating HPV lesions in people with HIV, which is different from the usual surgical removal or cryotherapy. Researchers are excited about its potential because it could provide a less invasive option with fewer side effects. Unlike other treatments, ACU-D1 is applied as an ointment, making it potentially more convenient and accessible for patients. The study explores how increasing concentrations of ACU-D1 might effectively treat these lesions, marking a novel strategy in the field.

What evidence suggests that ACU-D1 might be an effective treatment for HPV lesions in people with HIV?

Research has shown that ACU-D1 ointment might help treat HPV-related skin lesions in people with HIV. This trial will explore different dosages of ACU-D1, with participants receiving concentrations of 2.5%, 5%, or 10%. The treatment targets a protein called p53, which controls cell growth and can be affected by HPV infections. By activating p53 and related processes, ACU-D1 aims to stop the abnormal cell growth caused by the virus. Early findings also suggest that ACU-D1 might strengthen the body's immune response against HPV. These effects provide a promising basis for its potential effectiveness in managing HPV lesions in those with HIV. ^{1 2 3 6 7}

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

I am 21 years old or older.

I am infected with HIV.

I am capable of understanding and giving my consent for the trial.

Exclusion Criteria

Currently pregnant (confirmed by collecting urine for HCG pregnancy test) or lactating

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants apply ACU-D1 on the lesions twice daily for 4 weeks

4 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ACU-D1

Trial Overview 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.

How Is the Trial Designed?

Group I: Level 3 Experimental Treatment 2 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 2 Experimental Treatment 2 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 1 Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Georgia Center for Oncology Research & Education

Collaborator

Trials

3

Recruited

160+

Georgia Center For Oncology Research and Education

Collaborator

Trials

1

Recruited

9+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06233331

Use of ACU-D1 in HPV Associated Vulvar and Perianal ... 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.

2. withpower.com withpower.com/trial/acu-d1-ointment-for-hpv-lesions-in-people-with-hiv-8f34f

ACU-D1 Ointment for HPV 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.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06233331?term=AREA%5BConditionSearch%5D(%22Acquired%20Immunodeficiency%20Syndrome%22)%20AND%20AREA%5BInterventionSearch%5D(%22proteasome%20inhibitors%22)&rank=1

Use of ACU-D1 in HPV Associated Vulvar and Perianal ... A phase of research used to describe exploratory trials conducted before traditional phase 1 trials to investigate how or whether a drug affects the body. They ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5854529/

HIV-positive women have higher risk of HPV infection ... HIV-positive women have higher human papillomavirus (HPV) prevalence and cervical cancer (CC) incidence than HIV-negative women, partly due to HIV's modifying ...

5. clinicalinfo.hiv.gov clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-opportunistic-infections/human

Human Papillomavirus Disease: Adult and Adolescent OIs Guidance for the prevention and treatment of human papillomavirus (HPV) in adults and adolescents with HIV.

6. synapse.patsnap.com synapse.patsnap.com/drug/4c13988cb1d4459fb11b76546ac2d192

ACU-D1 - Drug Targets, Indications, Patents This study demonstrates that topical ACU-D1 is safe and well-tolerated by patients in the study and demonstrates efficacy in reducing inflammatory lesions and ...

7. ancora.ai ancora.ai/es/details/NCT06233331

Use of ACU-D1 in HPV Associated Vulvar and Perianal ... 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.