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New vaginal insert aims to clear persistent HPV in women

NCT ID NCT06491446

Disease control Sponsor: Antiva Biosciences 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 18, 2026 · Updated 2 times

Summary

This study tests an experimental vaginal insert (ABI-2280) to see if it can safely clear persistent high-risk human papillomavirus (HPV) infection in women aged 25 to 55. Participants must have had HPV for at least a year with no serious cervical changes. The study compares different doses against a placebo to check safety and how well the virus is cleared.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

141 people

The number who actually took part.

Started

Mar 2024

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

25 to 55 years

Sex

Female participants only

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 * Female sex, 25 to 55 years of age * Positive hrHPV result on at least 2 consecutive tests prior to randomization, one hrHPV+ result at least 12 months prior to screening * Cervical cytology, colposcopy and/or biopsy performed within the last 6 months confirming disease status no greater than low-grade squamous intraepithelial lesions or cervical intraepithelial neoplasia grade 1. Exclusion Criteria * History of biopsy or colposcopy indicating high-grade squamous intraepithelial lesions, or history of endocervical curettage positive for glandular dysplasia * Any clinically significant immune suppressing condition * History or current diagnosis of cervical cancer, suspected or confirmed * Plan to have excision or ablation of cervical or vaginal lesions, or to undergo large loop excision of the transformation zone at any time during the study.

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Conditions

The condition(s) this trial relates to.

human papilloma virus infection sexually transmitted disease

As listed by the trial registrant

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

Human papillomavirus infection

Contacts and locations

Locations

  • Arke Estudios Clinicos S.A. De C.V.

    Cuauhtémoc, CP 06700, Mexico

  • AusTrials Taringa

    Taringa, Australia

  • AusTrials Wellers Hill

    Tarragindi, Australia

  • Centro Oncologico Internacional

    Mexico City, CP 04700, Mexico

  • Clinical Horizons New Zealand

    Tauranga, New Zealand

  • Emeritus Research Camberwell

    Camberwell, Australia

  • Emeritus Research Sydney

    Sydney, Australia

  • FAICIC S. de R.L. de C.V.

    Veracruz, CP 91900, Mexico

  • Holdsworth House Medical Practice

    Darlinghurst, Australia

  • International Cancer Institute

    Eldoret, 8088-30100, Kenya

  • KIMR

    Nedlands, Australia

  • Kenya Medical Research Institute (KEMRI) - RCTP Kisumu

    Kisumu, 614-40100, Kenya

  • Lakeland Clinical Trials

    Rotorua, New Zealand

  • P3 Research Dunedin

    Dunedin, New Zealand

  • P3 Research Hawke's Bay

    Hastings, New Zealand

  • P3 Research Kapiti

    Paraparaumu, New Zealand

  • P3 Research Lower Hutt

    Lower Hutt, New Zealand

  • PARC Clinical Research, Royal Adelaide Hospital

    Adelaide, South Australia, Australia

  • Pacific Clinical Trials Network - Tasman

    Nelson, New Zealand

  • The Royal Women's Hospital

    Parkville, Australia

  • Unidad de Medicina Especializada SMA

    Querétaro, CP 76800, Mexico

  • Victoria Biomedical Research Institute

    Kisumu, 7180-40100, Kenya

  • Victoria Cancer Care & Research Centres

    Kisii, 1376-40500, Kenya

  • Waitemata Clinical Research Ltd

    Birkenhead, New Zealand

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