Clinical trial · Interventional
5-fluorouracil Following Cervical Intraepithelial Neoplasia Treatment Among HIV-positive Women in East Africa
NCT05362955CI-TRIAL-00080138completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CIN 2/3 | Cervical Intraepithelial Neoplasia Grade 2/3 | ALIAS | 0.90 |
| HIV Infections | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intravaginal 5-Fluorouracil (5-FU) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 5-FU Arm
- description
- intravaginal 2g 5-fluorouracil cream in every two weeks
- interventionNames
- Drug: Intravaginal 5-Fluorouracil (5-FU)
Primary outcomes (1)
- measure
- Safety of intravaginal 5-FU
- timeFrame
- Up to 5 months
- description
- 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.
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 49 Years
Show eligibility criteria text
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)
References
Publications (3)
- DERIVEDAdewumi 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 39980670
- DERIVEDAdewumi 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 39568790
- DERIVEDMungo 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 38168442