Using artesunate vaginal inserts to improve HPV treatment in HIV-positive women in Kenya
Feasibility of Intravaginal Artesunate as Adjuvant HPV & Cervical Precancer Treatment Among Women Living With HIV in Kenya
This study is testing whether using artesunate vaginal inserts can help improve HPV treatment outcomes for women living with HIV in Kenya.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 25 Years and up |
| Sex | Female |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation, prednisone |
| Locations | 1 site (Kisumu) |
| Trial ID | NCT06519994 on ClinicalTrials.gov |
What this trial studies
This randomized, placebo-controlled trial aims to evaluate the effectiveness of intravaginal artesunate pessaries as an adjuvant therapy for improving HPV treatment outcomes in women living with HIV. Participants will self-administer the artesunate or placebo nightly for five days, followed by a week off, over a total of three cycles. The study will assess HPV clearance rates at six months, as well as the safety, adherence, and acceptability of the treatment. A total of 120 women will be enrolled, all of whom will have undergone thermal ablation for cervical precancer.
Who should consider this trial
Good fit: Ideal candidates are women aged 25 years or older, HIV-positive, and on antiretroviral therapy for more than 90 days.
Not a fit: Patients who are currently pregnant, breastfeeding, or have a history of invasive cervical cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve HPV clearance rates and reduce the risk of cervical cancer in women living with HIV.
How similar studies have performed: While this approach is novel in this specific context, previous studies have shown varying success rates for HPV treatment in similar populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Kisumu
- Lumumba Sub-County Hospital KEMRI- Research Care Training Program (RCTP) Building — Kisumu, Kenya (Recruiting)
Study contacts
- Principal investigator: Chemtai Mungo, MD, MPH — UNC Lineberger Comprehensive Cancer Center
- Study coordinator: Kate Sorgi
- Email: kasorgi@email.unc.edu
- Phone: 919 966 5280
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.