Feasibility of Intravaginal Artesunate as Adjuvant HPV & Cervical Precancer Treatment in Kenya

Launched by UNC LINEBERGER COMPREHENSIVE CANCER CENTER · Jul 19, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring whether a treatment called intravaginal artesunate can help improve outcomes for women living with HIV who have been diagnosed with cervical precancer caused by the human papillomavirus (HPV). The goal is to see if using artesunate pessaries (vaginal inserts) after a specific treatment called thermal ablation can help clear HPV more effectively compared to a placebo (a treatment that looks the same but has no active ingredients). The study will include 120 women aged 25 and older who have been on HIV treatment for at least 90 days and have recently undergone thermal ablation for HPV.

Participants in the study will use the artesunate pessaries for five nights in a row, take a week off, and then repeat this for a total of three weeks. They will visit the clinic several times over six months for check-ups to monitor their health and the effectiveness of the treatment. It’s important for participants to be planning to stay in the study area and agree to use contraception if they can become pregnant. Overall, this trial aims to find a safe and effective way to help women with HIV clear HPV and prevent further complications.

Gender

FEMALE

Eligibility 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