NCT06519994CompletedPhase 2
Feasibility of Intravaginal Artesunate as Adjuvant HPV & Cervical Precancer Treatment in Kenya
Feasibility of Intravaginal Artesunate as Adjuvant HPV & Cervical Precancer Treatment Among Women Living With HIV in Kenya
Source: ClinicalTrials.gov · Last updated 14 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (actual)
- First submitted
- 19 Jul 2024
- Start date
- 22 Jan 2025
- Primary completion date
- 8 Apr 2026
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Diseases
- HIV
- NCT number
- NCT06519994
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 120
- From 22 Jan 2025 to the primary completion date, 8 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Prior chemotherapy within 30 days prior to day 1 of study treatment
Other illness
- Current or past history of invasive cervical cancer
- History of total hysterectomy
Other
- Current pregnancy or breastfeeding status
- Have medical comorbidity that, in the opinion of the investigator, would interfere with study participation
- Male at birth
Who the study is looking for
- 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
Age in the registry: 25 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lumumba Sub-County Hospital KEMRI- Research Care Training Program (RCTP) Building Coordinator of this site? Confirm its status | Kisumu | Kenya | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.