5-fluorouracil Following Cervical Intraepithelial Neoplasia Treatment Among HIV-positive Women in East Africa

UNC Lineberger Comprehensive Cancer Center

Status and phase: Completed; Phase 1

Conditions: CIN 2/3; HIV Infections

Treatments: Drug: Intravaginal 5-Fluorouracil (5-FU)

Study type: Interventional

Funder types: Other

Identifiers

NCT05362955

UNCPM22120

Details and patient eligibility

About

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).

Enrollment: 12 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Subjects must meet all of the inclusion criteria to participate in this study.

Inclusion Criteria:

1. HIV-positive women
2. Age 18 years - 49 years at enrollment
3. Documentation of a biopsy-confirmed CIN2 or CIN3
4. Within 4-12 weeks after primary treatment for CIN2 or CIN3
5. 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.
6. Agree to use dual contraception if of childbearing age (hormonal method, intrauterine or implant device, or tubal ligation - plus condoms) for duration of study
7. Ability to understand and willingness to sign (or assent when applicable) informed consent

Exclusion Criteria:

1. HIV-negative women
2. Pregnant or planning pregnancy within the next 6 months or breastfeeding
3. Unwilling or unable to use birth control during participation in the study
4. History of invasive cervical cancer
5. Untreated vaginal or vulvar dysplasia
6. Known allergy to 5-Fluorouracil
7. History of total hysterectomy
8. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient
9. Current use of chemotherapeutic medication or high dose steroids (10 mg prednisone per day or more (or equivalent steroids)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

5-FU Arm

Experimental group

Description:

intravaginal 2g 5-fluorouracil cream in every two weeks

Treatment:

Drug: Intravaginal 5-Fluorouracil (5-FU)