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Could a malaria drug help fight HPV in women with HIV?

NCT ID NCT06519994

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested whether a vaginal insert containing artesunate, a malaria drug, could help clear HPV after standard cervical precancer treatment in women living with HIV. 120 women in Kenya used the insert or a placebo for 5 nights on and off over 6 weeks. The goal was to see if the drug improved HPV clearance and was safe and easy to use.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

120 people

The number who actually took part.

Started

Jan 2025

Finished

Apr 2026

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

25 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 * Age 25 years or older * Known HIV seropositive status * On antiretroviral therapy for \> 90 days prior to enrollment * Weight ≥50 Kg at study entry\* * Positive HPV screening test and within 4-8 weeks of thermal ablation * Ability to provide informed consent * Planning to stay within the study locale during the duration of the study (24 weeks) * Agreement to use contraception (barriers or hormonal) if of childbearing age through week 6 of the study Exclusion Criteria * Current pregnancy or breastfeeding status * Current or past history of invasive cervical cancer * History of total hysterectomy * Currently receiving systemic chemotherapy or radiation therapy for another cancer * Current use of systemic immunosuppressants or steroids (\>10 mg of prednisone or equivalent) * Current use of efavirenz antiretroviral therapy, phenytoin, carbamazepine, and rifampin * Have medical comorbidity that, in the opinion of the investigator, would interfere with study participation * Prior chemotherapy within 30 days prior to day 1 of study treatment * Male at birth

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Conditions

The condition(s) this trial relates to.

AIDS cervical intraepithelial neoplasia dysplasia of cervix HIV infectious disease human papilloma virus infection

As listed by the trial registrant

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

Cervical precancer Human immunodeficiency virus Human papillomavirus

Contacts and locations

Locations

  • Lumumba Sub-County Hospital KEMRI- Research Care Training Program (RCTP) Building

    Kisumu, 614-40100, Kenya

More trials for these conditions

Other studies related to the condition(s) this trial covers.