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Phase 1Starting soon

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

Sponsored by Emory University

About this study

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.

From 2016 to 2019, Georgia faced the highest incidence of HIV diagnosis among the fifty states ranging from 40.2 to 26.2 per 100,000 individuals. HIV-infected men and women living in the southern United States experience inadequate treatment services despite bearing the highest burden of new infections as the modern epicenter of the HIV epidemic. There has been considerable research on racial disparities and HIV incidence, but there is a paucity of data on differences in treatment outcomes, particularly those related to comorbidities. HPV and HIV infection are the most significant risk factors for the development of High grade squamous intraepithelial lesion (HSIL), a documented precursor of cervical and anal cancer. While the mass availability of antiretroviral therapy has reduced the ri…

Where this study is enrolling

Who can participate

Inclusion criteria

  • ✓Age 21 years and older
  • ✓HIV-infected
  • ✓Able to provide informed consent
  • ✓Biopsy-proven HSIL disease of the vulvar and perianal region with a total disease volume of 3 cm or greater
  • ✓Combined antiretrovirals (cART) adherence
  • ✓CD4 count \> 200 cells/ml
  • ✓Sustained undetectable viral load for ≥ 3 months
  • ✓If applicable, on reliable birth control such as combined oral contraceptive pills (OCP), bilateral tubal ligation (BTL), a long-acting reversible contraceptive, or Depo-Provera (birth control shot)
  • ✓Willingness to conform to study requirements
  • ✓Reliable follow-up and contact information
  • ✓No risk factors or clinical suspicion for micro-invasive disease and absence of medical condition that interferes with the conduct of the study in the investigator's opinion

Exclusion criteria

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.