CIN 2/3Phase 1NCT05362955
5-fluorouracil Following Cervical Intraepithelial Neoplasia Treatment Among HIV-positive Women in East Africa
A Phase 1 study testing Intravaginal 5-Fluorouracil (5-FU) in people with CIN 2/3 and HIV Infections, run by UNC Lineberger Comprehensive Cancer Center at 1 site in Kenya.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- CIN 2/3, HIV Infections
- What is being tested?
- Intravaginal 5-Fluorouracil (5-FU)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteKenya
- Study dates
- 26 Apr 2023to 1 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Kenya1 site
Lumumba Sub-County Hospital KEMRI- Research Care Training Program (RCTP) Building
Kisumu, 614-40100
About this study
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
- CIN 2/3, HIV Infections
- Being tested
- Intravaginal 5-Fluorouracil (5-FU)
- Keywords
- cervical cancer, CIN 2/3, 5-Fluorouracil
- Medical subject headings
- HIV Infections, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravaginal 5-Fluorouracil (5-FU)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 5-FU Arm | Experimental | intravaginal 2g 5-fluorouracil cream in every two weeks Receives: Drug: Intravaginal 5-Fluorouracil (5-FU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 months
Secondary outcomes (4)
Tolerability of intravaginal 5-FU
Tolerability will be evaluated by assessing the number of participants experiencing specified adverse events (SAEs), defined as a Grade 3 or 4 toxicity that is possibly, probably, or definitely related to the study agent.
Measured: Up to 5 months
Adherence of intravaginal 5-FU
Adherence will be evaluated by assessing the number of participants who are confirmed to use 75% or more of the 5-FU applications.
Measured: Up to 5 months
Acceptability of intravaginal 5-FU
Responses to an acceptability questionnaire will be summarized, including means and standard deviation for responses to questions graded on a Likert scale (from 0 to 4), and proportions and 95% confidence intervals for yes/no questions.
Measured: Up to 20 weeks
Uptake of intravaginal 5-FU
The proportion of eligible screened participants who agree to participate in the trial and applied intravaginal 5-FU as the study defined.
Measured: Up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start26 Apr 2023
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CIN 2/3Studies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chemtai Mungo, MD, MPH, Principal investigator, Assistant Professor, Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362955
- Sponsor's protocol ID
- UNCPM22120
- Status last verified
- Aug 2024
- First submitted
- 2 May 2022
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 39980670Adewumi 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.
PubMed 39568790Mungo 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.
PubMed 38168442
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5-fluorouracil Following Cervical Intraepithelial Neoplasia Treatment Among HIV-positive Women in East Africa
- ClinicalTrials.gov ID
- NCT05362955
- Acronym / sponsor ID
- UNCPM22120
- Conditions
- CIN 2/3, HIV Infections
- Keywords
- cervical cancer, CIN 2/3, 5-Fluorouracil
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 5-FU Arm | Experimental | Drug: Intravaginal 5-Fluorouracil (5-FU)intravaginal 2g 5-fluorouracil cream in every two weeks |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravaginal 5-Fluorouracil (5-FU)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. | Drug | 5-FU Arm |
Primary outcome
Safety of intravaginal 5-FU
Time frame: Up to 5 months
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.
4 secondary outcomes
Tolerability of intravaginal 5-FU
Time frame: Up to 5 months
Adherence of intravaginal 5-FU
Time frame: Up to 5 months
Acceptability of intravaginal 5-FU
Time frame: Up to 20 weeks
Uptake of intravaginal 5-FU
Time frame: Up to 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Derived from this study: PubMed 39980670Adewumi 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.
- Derived from this study: PubMed 39568790Adewumi 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.
- Derived from this study: PubMed 38168442Mungo 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.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
Related trials for CIN 2/3
Not yet recruitingPhase 2
Adjuvant 5-Fluorouracil Following Thermal Ablation to Improve HPV Treatment Outcomes in Women With HIV in Kenya
HIV Infections, HPV Infection
Not yet recruitingObservational study
Peripheral Blood CyTOF Immune Model for Cervical Lesion Detection in HPV16/18+ Women
CIN 2/3, Cervical Cancer (Early Detection)
RecruitingPhase 2
PVX4 for the Treatment of Human Papilloma Virus (HPV)16+ Cervical Dysplasia
Cervical Intraepithelial Neoplasia Grade 2/3, Human Papilloma Virus Infection Type 16
RecruitingPhase 4
A Study to Assess the Reduction of Human Papillomavirus (HPV) Viral Infectivity and Transmission in HPV-Positive Women After Vaccination With 9vHPV (RIFT-HPV)
Cervical Intraepithelial Neoplasia Grade I/ II/ III (CIN I/II/III), Human Papillomavirus (HPV) Infections
RecruitingPhase 2
Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)
CIN 2/3, HPV Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chemtai Mungo, MD, MPH principal investigator
Assistant Professor, Obstetrics and Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intravaginal 5-Fluorouracil (5-FU) in people with CIN 2/3 and HIV Infections, run by UNC Lineberger Comprehensive Cancer Center at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of intravaginal 5-FU (time frame: Up to 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05362955, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.