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Could a cream after surgery stop cervical cancer in HIV-Positive women?

NCT ID NCT05413811

Disease control Sponsor: UNC Lineberger Comprehensive Cancer Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 21, 2026 · Updated 1 time

Summary

This study looked at whether using an anti-cancer cream (5-fluorouracil) in the vagina after surgery is an acceptable and feasible way to treat cervical precancer in 180 South African women living with HIV. The goal was to see if women would stick with the treatment and find it acceptable, not yet to prove it works. It's an early step toward possibly preventing cervical cancer in this high-risk group.

What this could mean

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

Active substance
5-fluorouracil cream
What this could lead to
If this combination approach is acceptable and effective, it could offer a better way to prevent cervical cancer in women with HIV.
What could go wrong
This was a small, early feasibility study (180 participants) focused on acceptability, not proof of cure. The results may not apply to all women or settings.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

180 people

The number who actually took part.

Started

Mar 2023

Finished

Jun 2025

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

18 years and older

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: * Confirmed HIV-1 infection * On antiretroviral therapy (ART), for at least 90 days prior to enrollment * Cervical biopsy demonstrating CIN2/3 within the preceding 120 days. Exclusion Criteria: * pregnancy, * breastfeeding, * intend to become pregnant within 180 days of enrollment * have an active sexually transmitted infection (women may participate once treated) * have a surgically absent cervix * have a history of anogenital (cervical, vaginal, vulvar, or anal) cancer or a biopsy suspicious for cervical cancer * have a medical comorbidity that would interfere with study participation.

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Conditions

The condition(s) this trial relates to.

AIDS cervical intraepithelial neoplasia grade 2/3 cervical squamous intraepithelial neoplasia HIV infectious disease human papilloma virus infection Uterine Cervical Neoplasms uterine cervix carcinoma in situ cervical cancer prevention target

As listed by the trial registrant

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

Cervical cancer CIN2 CIN3 Human immunodeficiency virus Human papillomavirus

Contacts and locations

Locations

  • Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital

    Westdene, Johannesburg, 2092, South Africa

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