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.

IntroductionCervical cancer disproportionately affects women in low- and middle-income countries (LMICs), who account for 90% of deaths from the disease. Human papillomavirus (HPV) is responsible for 99% of cervical cancer cases. Women living with HIV (WLWH) have a higher risk of persistent HPV infection and a greater likelihood of developing cervical cancer.

Phase I study on the pharmacokinetics of intravaginal, self-administered artesunate vaginal pessaries among women in Kenya.

Objectives: The primary objective of this study is to investigate the pharmacokinetics of Artesunate (AS) and its active metabolite, dihydroartemisinin (DHA) following intravaginal use at the dosing and frequency intended for cervical precancer treatment. A secondary objective is to assess safety among study participants.

Methods: We are conducting a single-arm, phase I trial with a sample size of 12 female volunteers.

WITHDRAWN: Intravaginal artesunate pessaries for treatment of cervical intraepithelial neoplasia 2/3 among HIV-positive and HIV-negative women in Kenya: Study protocol for a pilot trial.

The authors have withdrawn this manuscript because the article was posted prior to consultation from all relevant collaborators. If you have any questions, please contact the corresponding author.

Phase I study on the pharmacokinetics of intravaginal, self-administered artesunate vaginal pessaries among women in Kenya.

Unlabelled: Cervical cancer remains a significant global health issue, especially in low- and middle-income countries (LMICs), where access to prevention and treatment is limited and women are at a higher risk of cervical cancer. Artesunate, a widely available drug used to treat malaria, has shown promise in treating human papillomavirus (HPV)-associated anogenital lesions including high-grade cervical precancer, in a recent Phase I studies in the United States. Data on the pharmacokinetics of artesunate following intravaginal use, and its implications on malaria resistance, are lacking.