Status:
ACTIVE_NOT_RECRUITING
Feasibility of Intravaginal Artesunate as Adjuvant HPV & Cervical Precancer Treatment in Kenya
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Kenya Medical Research Institute
Conditions:
Human Immunodeficiency Virus
Human Papillomavirus
Eligibility:
FEMALE
25+ years
Phase:
PHASE2
Brief 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 impr...
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 hum...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06519994
Start Date
January 22 2025
End Date
April 8 2026
Last Update
December 17 2025
Active Locations (1)
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1
Lumumba Sub-County Hospital KEMRI- Research Care Training Program (RCTP) Building
Kisumu, Kenya, 614-40100