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New cream could fight HPV lesions in HIV patients

NCT ID NCT06233331

Disease control Sponsor: Emory University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 19, 2026 · Updated 3 times

Summary

This early-stage trial tests a topical ointment called ACU-D1 for HPV-related vulvar and perianal lesions in people with HIV. Nine participants will apply the cream twice daily for 4 weeks. The main goal is to find the safest dose and see if the treatment can boost immune markers against HPV.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ACU-D1 ointment (proteasome inhibitor)
What this could lead to
If successful, this could point toward a topical treatment for HPV-related lesions in people with HIV, potentially reducing the need for surgery.
What could go wrong
This is a very early Phase 1 trial with only 9 participants, so it is primarily testing safety and dosing. It may not show clear effectiveness, and side effects are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 9 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

AIDS anal canal carcinoma in situ HIV infectious disease human papilloma virus infection squamous cell intraepithelial neoplasia Squamous Intraepithelial Lesions vulvar intraepithelial neoplasia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anal intraepithelial neoplasia High-grade squamous intraepithelial lesions Human immunodeficiency virus Human papilloma virus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Grady Memorial Hospital

    Atlanta, Georgia, 30303, United States

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