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

9 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug ACU-D1 for treating HPV lesions in people with HIV?

Research shows that similar treatments, like cidofovir, have been effective in clearing HPV lesions in HIV-positive patients, with some studies reporting complete clearance and no relapses over extended follow-up periods. ^{1 2 3 4 5}

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. ^{1 2 5 6 7}

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 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.

Research Team

Lisa Flowers, MD, MPH

Principal Investigator

Emory University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Human papillomavirus (HPV) viral load and HPV type in the clinical outcome of HIV-positive patients treated with imiquimod for anogenital warts and anal intraepithelial neoplasia. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Resolution of recurrent perianal condylomata acuminata by topical cidofovir in patients with HIV infection. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Treatment of intraurethral condylomata acuminata with surgery and cidofovir instillations in two immunocompromised patients and review of the literature. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Anogenital warts and other HPV-associated anogenital lesions in the HIV-positive patient: a systematic review and meta-analysis of the efficacy and safety of interventions assessed in controlled clinical trials. [2018]

5. England pubmed.ncbi.nlm.nih.gov

A randomized, controlled, safety study using imiquimod for the topical treatment of anogenital warts in HIV-infected patients. Imiquimod Study Group. [2020]

6. England pubmed.ncbi.nlm.nih.gov

A trial of topical idoxuridine for vulvar condyloma acuminatum. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of physically ablative and pharmacological treatments for anal condyloma in HIV-infected men. [2019]