NCT05362955CompletedPhase 1
5-fluorouracil Following Cervical Intraepithelial Neoplasia Treatment Among HIV-positive Women in East Africa
Source: ClinicalTrials.gov · Last updated 23 Aug 2024
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 2 May 2022
- Start date
- 26 Apr 2023
- Primary completion date
- 1 Feb 2024
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Diseases
- HIV, Cervical cancer
- NCT number
- NCT05362955
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 12
- From 26 Apr 2023 to the primary completion date, 1 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of chemotherapeutic medication or high dose steroids (10 mg prednisone per day or more (or equivalent steroids)
Other illness
- HIV-negative women
- History of invasive cervical cancer
- Known allergy to 5-Fluorouracil
- History of total hysterectomy
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient
Other
- Pregnant or planning pregnancy within the next 6 months or breastfeeding
- Unwilling or unable to use birth control during participation in the study
- Untreated vaginal or vulvar dysplasia
Who the study is looking for
- 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
Criteria the registry did not label
- Subjects must meet all of the inclusion criteria to participate in this study.
Age in the registry: 18 years to 49 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lumumba Sub-County Hospital KEMRI- Research Care Training Program (RCTP) Building Coordinator of this site? Confirm its status | Kisumu | Kenya | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.