Human Immunodeficiency VirusPhase 2NCT06519994
Feasibility of Intravaginal Artesunate as Adjuvant HPV & Cervical Precancer Treatment in Kenya
A Phase 2 study testing Artesunate vaginal inserts in people with Human Immunodeficiency Virus and Human Papillomavirus, run by UNC Lineberger Comprehensive Cancer Center at 1 site in Kenya.
Trial summary
The objective of this randomized, placebo-controlled trial is to evaluate whether intravaginal artesunate pessaries (vaginal inserts) can be used as adjuvant therapy following thermal ablation to improve Human papillomavirus (HPV) treatment outcomes in Women Living with Human Immunodeficiency Virus (WLWH). Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Human Immunodeficiency Virus, Human Papillomavirus, Cervical Precancer
- What is being tested?
- Artesunate vaginal inserts
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteKenya
- Study dates
- 22 Jan 2025to 8 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Kenya1 site
Lumumba Sub-County Hospital KEMRI- Research Care Training Program (RCTP) Building
Kisumu, 614-40100
About this study
Official title: Feasibility of Intravaginal Artesunate as Adjuvant HPV & Cervical Precancer Treatment Among Women Living With HIV in Kenya
The objective of this randomized, placebo-controlled trial is to evaluate whether intravaginal artesunate pessaries (vaginal inserts) can be used as adjuvant therapy following thermal ablation to improve Human papillomavirus (HPV) treatment outcomes in Women Living with Human Immunodeficiency Virus (WLWH).
The study will evaluate whether women who use artesunate will have higher HPV clearance at 6 months, compared to those who used a placebo. The study will also assess the safety, adherence, and acceptability of this treatment. 120 participants will be enrolled in the study. Participants will self-administer the study drug nightly for 5 days, take a week off, and repeat twice (use study drug on weeks 1, 3,5) and will return to the clinic on weeks 2, 4, 6, 12, and week 24 for follow-up.
Read the detailed description
WLWH face up to six times increased risk of cervical cancer, as a result, cervical cancer is a leading cause of death in this population. Cervical cancer is caused by persistent infection with the human papillomavirus (HPV), resulting in precancerous changes that if not adequately treated, progress to cancer. Thermal ablation is a commonly used treatment for cervical precancer in Kenya and other low- and middle-income countries (LMICs). Current treatments for HPV or cervical precancer, including thermal ablation, are associated with high rates of treatment failure in WLWH. In a recent study from Zambia, only 44% of WLWH had cleared HPV at six months following thermal ablation treatment. Other studies have demonstrated up to 30% recurrence rate of high-grade cervical precancer at 12 to 24 months after treatment. Persistent infection with HPV following precancer treatment is a key risk factor for treatment disease recurrence.
- Being tested
- Artesunate vaginal inserts, Placebo vaginal inserts
- Keywords
- intravaginal, self-administer, artesunate, intravaginal artesunate, vaginal pessaries
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artesunate vaginal insertsDrug
Subjects will self-administer 200 mg of Artesunate vaginal insert daily for 5 days, on weeks 1, 3, 5.
Placebo vaginal insertsDrug
Subjects will self-administer a placebo vaginal insert daily for 5 days, on weeks 1, 3, 5.
| Study group | Role | What they receive |
|---|---|---|
| Artesunate vaginal inserts | Experimental | Participants will self-administer the study drug nightly for 5 days, take a week off, and repeat 2 times (study drug application on weeks 1, 3, 5). Receives: Drug: Artesunate vaginal inserts |
| Placebo vaginal inserts | Placebo comparator | Participants will self-administer the study placebo nightly for 5 days, take a week off, and repeat 2 times (study drug application on weeks 1, 3, 5). Receives: Drug: Placebo vaginal inserts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance of type-specific HPV genotype(s)
The number and proportion of women in each study arm who demonstrate clearance of the specific HPV genotype, or genotypes (if multiple) between baseline and six months will be reported.
Measured: 24 weeks
Secondary outcomes (2)
Adherence
Adherence will be evaluated based on the number and proportion of women confirmed self-administration of at least 80% (12 of 15) vaginal inserts.
Measured: Week 6
Acceptability measured by acceptability questionnaire
Acceptability will be evaluated based on a close-ended structured acceptability questionnaire. The responses will be on a Likert score, between 1-5, and higher scores represent better accepted.
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start22 Jan 2025
- Primary completion8 Apr 2026
- Study completion8 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Kenya Medical Research Institute, Maseno University School of Medicine, Kenya
- Responsible party
- Sponsor
- Investigators
- Chemtai Mungo, MD, MPH, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519994
- Sponsor's protocol ID
- LCCC2330
- Other IDs
- R34CA284983
- Status last verified
- May 2026
- First submitted
- 19 Jul 2024
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sadana A, Omoto J, Sorgi K, Rahangdale L, Smith JS, Plesa M, Mungo C. Feasibility of Intravaginal Artesunate as an Adjuvant HPV & Cervical Precancer Treatment Among Women Living With HIV in Kenya: Study Protocol for a Phase II Clinical Trial. Cancer Control. 2025 Jan-Dec;32:10732748251374418. doi: 10.1177/10732748251374418. Epub 2025 Sep 4.
PubMed 40907021
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Intravaginal Artesunate as Adjuvant HPV & Cervical Precancer Treatment Among Women Living With HIV in Kenya
- ClinicalTrials.gov ID
- NCT06519994
- Acronym / sponsor ID
- LCCC2330
- Keywords
- intravaginal, self-administer, artesunate, intravaginal artesunate, vaginal pessaries
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Kenya Medical Research Institute, Maseno University School of Medicine, Kenya
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 8 Apr 2026 (actual)
- Study completion
- 8 Apr 2026 (actual)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this randomized, placebo-controlled trial is to evaluate whether intravaginal artesunate pessaries (vaginal inserts) can be used as adjuvant therapy following thermal ablation to improve Human papillomavirus (HPV) treatment outcomes in Women Living with Human Immunodeficiency Virus (WLWH).
The study will evaluate whether women who use artesunate will have higher HPV clearance at 6 months, compared to those who used a placebo. The study will also assess the safety, adherence, and acceptability of this treatment. 120 participants will be enrolled in the study. Participants will self-administer the study drug nightly for 5 days, take a week off, and repeat twice (use study drug on weeks 1, 3,5) and will return to the clinic on weeks 2, 4, 6, 12, and week 24 for follow-up.
Detailed description
WLWH face up to six times increased risk of cervical cancer, as a result, cervical cancer is a leading cause of death in this population. Cervical cancer is caused by persistent infection with the human papillomavirus (HPV), resulting in precancerous changes that if not adequately treated, progress to cancer. Thermal ablation is a commonly used treatment for cervical precancer in Kenya and other low- and middle-income countries (LMICs). Current treatments for HPV or cervical precancer, including thermal ablation, are associated with high rates of treatment failure in WLWH. In a recent study from Zambia, only 44% of WLWH had cleared HPV at six months following thermal ablation treatment. Other studies have demonstrated up to 30% recurrence rate of high-grade cervical precancer at 12 to 24 months after treatment. Persistent infection with HPV following precancer treatment is a key risk factor for treatment disease recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Artesunate vaginal inserts | Experimental | Drug: Artesunate vaginal insertsParticipants will self-administer the study drug nightly for 5 days, take a week off, and repeat 2 times (study drug application on weeks 1, 3, 5). |
| Placebo vaginal inserts | Placebo comparator | Drug: Placebo vaginal insertsParticipants will self-administer the study placebo nightly for 5 days, take a week off, and repeat 2 times (study drug application on weeks 1, 3, 5). |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artesunate vaginal insertsSubjects will self-administer 200 mg of Artesunate vaginal insert daily for 5 days, on weeks 1, 3, 5. | Drug | Artesunate vaginal inserts |
| Placebo vaginal insertsSubjects will self-administer a placebo vaginal insert daily for 5 days, on weeks 1, 3, 5. | Drug | Placebo vaginal inserts |
Primary outcome
Clearance of type-specific HPV genotype(s)
Time frame: 24 weeks
The number and proportion of women in each study arm who demonstrate clearance of the specific HPV genotype, or genotypes (if multiple) between baseline and six months will be reported.
2 secondary outcomes
Adherence
Time frame: Week 6
Acceptability measured by acceptability questionnaire
Time frame: Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Derived from this study: PubMed 40907021Sadana A, Omoto J, Sorgi K, Rahangdale L, Smith JS, Plesa M, Mungo C. Feasibility of Intravaginal Artesunate as an Adjuvant HPV & Cervical Precancer Treatment Among Women Living With HIV in Kenya: Study Protocol for a Phase II Clinical Trial. Cancer Control. 2025 Jan-Dec;32:10732748251374418. doi: 10.1177/10732748251374418. Epub 2025 Sep 4.
- Clinical trials at UNC LinebergerLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chemtai Mungo, MD, MPH principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Artesunate vaginal inserts in people with Human Immunodeficiency Virus and Human Papillomavirus, run by UNC Lineberger Comprehensive Cancer Center at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clearance of type-specific HPV genotype(s) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06519994, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.