drugset / Trial / NCT05362955
5-fluorouracil Following Cervical Intraepithelial Neoplasia Treatment Among HIV-positive Women in East Africa
NaSingle-groupOpen-labelTreatment
Summary
This is a single arm study on the safety, feasibility, and acceptability of adjuvant, self-administered, intravaginal 5-Fluorouracil (5-FU) following treatment for high-grade cervical precancer (CIN2/3) among women living with human immunodeficiency virus (HIV).
Timeline
- Start
- 2023-04-26
- Primary completion
- 2024-02-01
- Completion
- 2024-02-01
Publications
- Adewumi K, Kachoria AG, Adoyo E, Rop M, Owaya A, Tang JH, Rahangdale L, Mungo C. Women's experiences and acceptability of self-administered, home delivered, intravaginal 5-Fluorouracil cream for cervical precancer treatment in Kenya. Front Reprod Health. 2025 Feb 6;7:1487264. doi: 10.3389/frph.2025.1487264. eCollection 2025.
- Adewumi K, Kachoria AG, Adoyo E, Rop M, Owaya A, Tang JH, Rahangdale L, Mungo C. Women's experiences and acceptability of self-administered, home delivered, intravaginal 5-Fluorouracil cream for cervical precancer treatment in Kenya. medRxiv [Preprint]. 2025 Jan 2:2024.08.27.24312651. doi: 10.1101/2024.08.27.24312651.
- Mungo C, Bukusi E, Kirkland GE, Ogollah C, Rota G, Omoto J, Rahangdale L. Feasibility of adjuvant self-administered intravaginal 5-fluorouracil cream following primary treatment of cervical intraepithelial neoplasia grade 2 or 3 among women living with HIV in Kenya: study protocol for a pilot trial. medRxiv [Preprint]. 2023 Dec 14:2023.12.13.23299916. doi: 10.1101/2023.12.13.23299916.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | fluorouracil | Small molecule | 5 % | Other |
| Subject | fluorouracil | Small molecule | 2 g | Other |