Status:
COMPLETED
5-fluorouracil Following Cervical Intraepithelial Neoplasia Treatment Among HIV-positive Women in East Africa
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Conditions:
CIN 2/3
HIV Infections
Eligibility:
FEMALE
18-49 years
Phase:
PHASE1
Brief 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/...
Eligibility Criteria
Inclusion
- Subjects must meet all of the inclusion criteria to participate in this study.
- 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
- 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
- History of invasive cervical cancer
- Untreated vaginal or vulvar dysplasia
- 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
- Current use of chemotherapeutic medication or high dose steroids (10 mg prednisone per day or more (or equivalent steroids)
Key Trial Info
Start Date :
April 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05362955
Start Date
April 26 2023
End Date
February 1 2024
Last Update
August 23 2024
Active Locations (1)
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1
Lumumba Sub-County Hospital KEMRI- Research Care Training Program (RCTP) Building
Kisumu, Kenya, 614-40100