5-fluorouracil Following Cervical Intraepithelial Neoplasia Treatment Among HIV-positive Women in East Africa
1 other identifier
interventional
12
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2022
CompletedFirst Posted
Study publicly available on registry
May 5, 2022
CompletedStudy Start
First participant enrolled
April 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2024
CompletedAugust 23, 2024
August 1, 2024
9 months
May 2, 2022
August 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of intravaginal 5-FU
Safety will be evaluated as type, frequency, and severity of Adverse Events (AE)s. AEs will be evaluated according to the National Institute of Health (NIH) Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Event Grading Tables. The DAIDS grading table provides an AE severity grading scale ranging from grades 1 to 5. Grade 1 indicates a mild event, Grade 2 indicates a moderate event, Grade 3 indicates a severe event, Grade 4 indicates a potentially life-threatening event and Grade 5 indicates death.
Up to 5 months
Secondary Outcomes (4)
Tolerability of intravaginal 5-FU
Up to 5 months
Adherence of intravaginal 5-FU
Up to 5 months
Acceptability of intravaginal 5-FU
Up to 20 weeks
Uptake of intravaginal 5-FU
Up to 20 weeks
Study Arms (1)
5-FU Arm
EXPERIMENTALintravaginal 2g 5-fluorouracil cream in every two weeks
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lumumba Sub-County Hospital KEMRI- Research Care Training Program (RCTP) Building
Kisumu, 614-40100, Kenya
Related Publications (3)
Adewumi K, Kachoria AG, Adoyo E, Rop M, Owaya A, Tang JH, Rahangdale L, Mungo C. Women's experiences and acceptability of self-administered, home delivered, intravaginal 5-Fluorouracil cream for cervical precancer treatment in Kenya. Front Reprod Health. 2025 Feb 6;7:1487264. doi: 10.3389/frph.2025.1487264. eCollection 2025.
PMID: 39980670DERIVEDAdewumi K, Kachoria AG, Adoyo E, Rop M, Owaya A, Tang JH, Rahangdale L, Mungo C. Women's experiences and acceptability of self-administered, home delivered, intravaginal 5-Fluorouracil cream for cervical precancer treatment in Kenya. medRxiv [Preprint]. 2025 Jan 2:2024.08.27.24312651. doi: 10.1101/2024.08.27.24312651.
PMID: 39568790DERIVEDMungo C, Bukusi E, Kirkland GE, Ogollah C, Rota G, Omoto J, Rahangdale L. Feasibility of adjuvant self-administered intravaginal 5-fluorouracil cream following primary treatment of cervical intraepithelial neoplasia grade 2 or 3 among women living with HIV in Kenya: study protocol for a pilot trial. medRxiv [Preprint]. 2023 Dec 14:2023.12.13.23299916. doi: 10.1101/2023.12.13.23299916.
PMID: 38168442DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chemtai Mungo, MD, MPH
Assistant Professor, Obstetrics and Gynecology
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2022
First Posted
May 5, 2022
Study Start
April 26, 2023
Primary Completion
February 1, 2024
Study Completion
February 1, 2024
Last Updated
August 23, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.