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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21+
SponsorEmory University

About 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Dose Level 1 ACU-D1 ointment
  • Dose Level 2 ACU-D1 ointment
  • Dose Level 3 ACU-D1 ointment
  • Vulvar/ Perianal Biopsy

Treatment groups

9 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Emory University

Lead sponsor

Georgia Center for Oncology Research & Education

Collaborator