This phase I trial tests the safety and side effects of fluorouracil self-administered into the vagina (intravaginal) following main treatment for cervical intraepithelial neoplasia grade 2 and 3 (CIN2/3) among women who are human immunodeficiency virus (HIV)-positive and living in Malawi. Fluorouracil is in a class of medications called antimetabolites. It works by killing fast-growing abnormal cells. Giving self-administered after main treatment for CIN2/3 may kill any remaining abnormal cells and may prevent the disease from returning.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05362955.
PRIMARY OBJECTIVE:
I. To evaluate the safety of adjuvant self-administered intravaginal 5-fluorouracil (5-FU) following cervical intraepithelial neoplasia grades 2/3 (CIN2/3) treatment among women living with human immunodeficiency virus (WLWH) in Malawi, at the proposed dose and frequency.
SECONDARY OBJECTIVES:
I. To evaluate the uptake of adjuvant, self-administered, intravaginal 5-FU following CIN2/3 among WLWH in Malawi.
II. To evaluate the tolerability of self-administered 5-FU following CIN2/3 treatment, at the proposed dose and frequency among WLWH in Malawi.
III. To evaluate adherence to self-administered 5-FU following CIN2/3 treatment, at the proposed dose and frequency among WLWH in Malawi.
IV. To evaluate acceptability of adjuvant 5-FU following CIN2/3 treatment among WLWH in low-and middle-income countries (LMICs).
OUTLINE:
Patients self-administer fluorouracil intravaginally every other week (weeks 1, 3, 5, 7, 9, 11, 13, 15).
After study completion patients follow-up at week 20 for safety visit.
Lead OrganizationUNC Lineberger Comprehensive Cancer Center
Principal InvestigatorChemtai Mungo
