Human Immunodeficiency Virus Clinical Trial
Official title:
Phase I Dose Escalation Study of the Use of ACU-D1, a Topical Proteasome Inhibitor in HPV Associated Vulvar and Perianal 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. 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.
Status | Not yet recruiting |
Enrollment | 9 |
Est. completion date | May 2025 |
Est. primary completion date | May 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Grady Memorial Hospital | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University | Georgia Center for Oncology Research & Education |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum tolerated dose (MTD) of ACU-D1 | Subjects will be monitored during the trial for adverse events, tolerability and compliance using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
The dose level at which no more than 33% of study participants have a DLT will be considered the maximum tolerated dose. |
Baseline, week 4 | |
Secondary | Ability of ACU-D1 to induce p53 and p21 in HPV lesions | The biopsies collected at the the 1st study visit and at the last study visit (week 4) mark will be examined using immunohistochemistry to determine gene activity and be used for other biomolecular assays | Baseline, week 4 | |
Secondary | Safety of ACU-D1: Time of maximum observed concentration (tmax) | Pharmacokinetic studies will be performed on 3 participants after the 4th week of 10% ACU-D1 ointment application. As part of the studies, these 3 subjects will be admitted to the Grady satellite of the Atlanta Clinical and Translational Science Institute (ACTSI) where blood and urine samples will be collected in quick succession. | Before ointment application (0hr), 0.25 hour, 0.50 hour, 1hour, 1.5 hour, 2 hour, 4, 8 hour and 12 hour | |
Secondary | Safety of ACU-D1: Maximum concentration (Cmax) | Pharmacokinetic studies will be performed on 3 participants after the 4th week of 10% ACU-D1 ointment application. As part of the studies, these 3 subjects will be admitted to the Grady satellite of the Atlanta Clinical and Translational Science Institute (ACTSI) where blood and urine samples will be collected in quick succession. | Before ointment application (0hr), 0.25 hour, 0.50 hour, 1hour, 1.5 hour, 2 hour, 4, 8 hour and 12 hour | |
Secondary | Safety of ACU-D1: Area under the concentration-time curve for the last measurable concentration (AUC0-last) | Pharmacokinetic studies will be performed on 3 participants after the 4th week of 10% ACU-D1 ointment application. As part of the studies, these 3 subjects will be admitted to the Grady satellite of the Atlanta Clinical and Translational Science Institute (ACTSI) where blood and urine samples will be collected in quick succession. | Before ointment application (0hr), 0.25 hour, 0.50 hour, 1hour, 1.5 hour, 2 hour, 4, 8 hour and 12 hour |
Status | Clinical Trial | Phase | |
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