Trials / Completed
CompletedNCT05362955
5-fluorouracil Following Cervical Intraepithelial Neoplasia Treatment Among HIV-positive Women in East Africa
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- UNC Lineberger Comprehensive Cancer Center · Academic / Other
- Sex
- Female
- Age
- 18 Years – 49 Years
- Healthy volunteers
- Accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Intravaginal 5-Fluorouracil (5-FU) | Participants will self-administer 2 g of 5% 5-FU intravaginally using an applicator, one night per week (every other week), on weeks 1, 3, 5, 7, 9, 11, 13, 15, for a total of 8 applications. |
Timeline
- Start date
- 2023-04-26
- Primary completion
- 2024-02-01
- Completion
- 2024-02-01
- First posted
- 2022-05-05
- Last updated
- 2024-08-23
Locations
1 site across 1 country: Kenya
Source: ClinicalTrials.gov record NCT05362955. Inclusion in this directory is not an endorsement.