5-fluorouracil Following Cervical Intraepithelial Neoplasia Treatment Among HIV-positive Women in… (NCT05362955) | Clinical Trial Compass
CompletedPhase 1
5-fluorouracil Following Cervical Intraepithelial Neoplasia Treatment Among HIV-positive Women in East Africa
Kenya12 participantsStarted 2023-04-26
Plain-language 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).
Who can participate
Age range18 Years – 49 Years
SexFEMALE
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Inclusion criteria
✓. HIV-positive women
✓. Age 18 years - 49 years at enrollment
✓. Documentation of a biopsy-confirmed CIN2 or CIN3
✓. Within 4-12 weeks after primary treatment for CIN2 or CIN3
✓. Negative pregnancy test at screening and agreement to use dual form of contraception (hormonal birth control, intrauterine device, or tubal ligation - plus condoms) during the study duration, if of childbearing age.
✓. Agree to use dual contraception if of childbearing age (hormonal method, intrauterine or implant device, or tubal ligation - plus condoms) for duration of study
✓. Ability to understand and willingness to sign (or assent when applicable) informed consent
Exclusion criteria
✕. HIV-negative women
✕. Pregnant or planning pregnancy within the next 6 months or breastfeeding
✕. Unwilling or unable to use birth control during participation in the study