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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT06233331
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dose Level 1 ACU-D1 ointment — DRUG
    ACU-D1 is a topical therapeutic agent that has pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionate) (PTTC) as its major active ingredient. PTTC is a novel proteasome inhibitor that has antiangiogenic and anti-inflammatory activities that reduce pro-inflammatory cytokines. ACU-D1 ointment contains a range of 2.5% to 10% weight by volume of PTTC. Level 1 will consist of 2.5% ACU-D1 ointment, used twice daily for 4 weeks.
  • Dose Level 2 ACU-D1 ointment — DRUG
    Level 2 will consist of 5% ACU-D1 ointment, used twice daily for 4 weeks.
  • Dose Level 3 ACU-D1 ointment — DRUG
    Level 3 will consist of 10% ACU-D1 ointment, used twice daily for 4 weeks.
  • Vulvar/ Perianal Biopsy — PROCEDURE
    3 vulvar or perianal biopsies are to be performed at the screening as well as at the end of the study (week 4).

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
9 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Level 1
    Initial three study participants will be enrolled in Dose Level 1, 2.5% ACU-D1 twice daily for 4 weeks.
  • Experimental: Level 2
    If there are no DLTs to Dose Level 1 then, 3 new study participants will proceed to Dose Level 2 at 5% ACU-D1.
  • Experimental: Level 3
    If there are no DLTs to Dose Level 2 then, 3 new study participants will proceed to Dose Level 3 at 10 % ACU-D1.

Primary Outcome Measure

Maximum tolerated dose (MTD) of ACU-D1 [ Time Frame: Baseline, week 4 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Grady Memorial HospitalAtlantaGeorgia30303
Lisa Flowers, MD
[email protected]
404-251-8931

Find similar trials in Atlanta, GA

By condition
HIV
By specialty
Infectious disease
By research site
Grady Memorial Hospital· Atlanta, GA

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