Use of ACU-D1 in HPV Associated Vulvar and Perianal Lesions in People With HIV
Launched by EMORY UNIVERSITY · Jan 30, 2024
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating a treatment called ACU-D1 for people living with HIV who have certain lesions (abnormal growths) caused by the Human Papilloma Virus (HPV) in the vulvar and perianal areas. The main goals of the study are to find out the highest safe dose of ACU-D1, determine how well the treatment is tolerated, and see if it helps activate the immune system against HPV-related lesions. Participants will apply ACU-D1 to the affected areas twice a day for four weeks and will have a few biopsies (small tissue samples) taken to monitor their condition.
To be eligible for this trial, participants must be at least 21 years old, diagnosed with HIV, and have specific types of lesions confirmed by a biopsy. They also need to be on effective HIV treatment and have a good immune system (with a CD4 count above 200). Pregnant or breastfeeding individuals cannot participate. If you qualify and decide to join the study, you'll need to follow the treatment plan and keep in touch with the research team throughout the trial. This is an important step in finding new options for managing HPV-related health issues in people with HIV.
Gender
ALL
Eligibility criteria
- 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
About Emory University
Emory University, a leading research institution located in Atlanta, Georgia, is dedicated to advancing medical knowledge and improving patient care through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, Emory harnesses the expertise of its renowned faculty and state-of-the-art facilities to conduct cutting-edge research across various fields, including oncology, neurology, and infectious diseases. The university's commitment to ethical research practices and patient safety ensures that all clinical trials are designed to generate valuable data that can lead to significant therapeutic advancements. By fostering partnerships with local hospitals and community organizations, Emory strives to translate research findings into real-world applications, ultimately enhancing health outcomes for diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Atlanta, Georgia, United States
Patients applied
Trial Officials
Lisa Flowers, MD, MPH
Principal Investigator
Emory University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported