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NCT05362955 | Active, not recruiting | CIN 2/3

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

UNC Lineberger Comprehensive Cancer Center

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 (CIN2/3) among women living with human immunodeficiency virus (HIV).

Condition or disease

CIN 2/3

HIV Infections

Intervention/treatment

Intravaginal 5-Fluorouracil (5-FU)

Phase

Phase 1

Study Type : Interventional
Estimated Enrollment : 12 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : 5-fluorouracil Following Cervical Intraepithelial Neoplasia Treatment Among HIV-positive Women in East Africa
Actual Study Start Date : April 26, 2023
Estimated Primary Completion Date : August 1, 2024
Estimated Study Completion Date : August 1, 2024
Arm Intervention/treatment

Experimental: 5-FU Arm

intravaginal 2g 5-fluorouracil cream in every two weeks

Drug: Intravaginal 5-Fluorouracil (5-FU)
Ages Eligible for Study: 18 Years to 49 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Subjects must meet all of the inclusion criteria to participate in this study.
  • 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
    • 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)
    • 5-fluorouracil Following Cervical Intraepithelial Neoplasia Treatment Among HIV-positive Women in East Africa

    Location Details

    Please Choose a site

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

    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    Not yet recruiting

    Kenya,

    Lumumba Sub-County Hospital KEMRI- Research Care Training Program (RCTP) Building

    Kisumu, Kenya, 614-40100