Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202401582817992 Date of Registration: 15/01/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title UNCPM 22120 5-FU Study
Official scientific title UNCPM 22120: Safety of adjuvant, self-administered intravaginal 5-fluorouracil (5-FU) cream following cervical intraepithelial neoplasia grade 2 and 3 (CIN2/3) treatment among HIV-positive women in Kenya: A pilot study
Brief summary describing the background and objectives of the trial Women living with HIV face up to six times increased risk of cervical cancer, and cervical cancer is a leading cause of death in this population. Current approved treatment for high-grade cervical precancer, scientifically termed cervical intraepithelial neoplasia grade 2 or 3 (CIN2/3), is either ablation (cryotherapy or thermal ablation) or excision. Both treatment methods are associated with high rates of CIN2/3 treatment failure in women with HIV, up to 30% at one year. Studies in high-income countries have demonstrated that off-label use of self-administered, intravaginal 5% 5-FU cream following primary CIN2/3 treatment in HIV-positive women can reduce treatment failure. This is a single arm pilot study investigating the safety, uptake, tolerability, adherence, and acceptability of off-label self-administered intravaginal 5% fluorouracil (5-FU) cream as adjuvant therapy following primary treatment for CIN2/3 among women living with HIV in Kenya. Fourteen participants will be enrolled. Participants will self-administer 2 grams of 5% 5-FU cream intravaginally biweekly (every other week, on weeks 1, 3, 5, 7, 9, 11, 13, 15) for a total of 8 applications, and will return to the clinic on weeks 2, 4, 6, 8,10, 12, 14, and 16 for safety and adherence assessments, including a pelvic exam by a trained clinician. Our hypothesis is that adjuvant, self-administered 5% 5-FU cream, used intravaginally at the proposed dose and frequency will be safe, tolerable, and acceptable for use among this population. Our hypothesis is that adjuvant, intravaginal, self-administered 5% 5-FU cream at the proposed dose and frequency will be safe, tolerable, and acceptable for use among this population. This trial, together with data from other studies, will support proceeding to a randomized phase II or phase III trial in Kenya to investigate whether this intervention will reduce CIN2/3 recurrence as has been demonstrated in other settings.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/03/2023
Actual trial start date 01/03/2023
Anticipated date of last follow up 01/03/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 12
Actual target sample size (number of participants) 12
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Adjuvant self administered 5FU Cream 2 grams of cream admisnistered every other week (bi-weekly) 8 weeks Self-administered intravaginal 5% fluorouracil (5-FU) cream as adjuvant therapy following primary treatment for CIN2/3 among women living with HIV in Kenya. 12
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. HIV-positive women (confirmed with serum antibody testing) 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 (either cryotherapy, thermal ablation, or loop electrosurgical excision procedure (LEEP)) for CIN2 or CIN3 5. Negative pregnancy test at screening 6. 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. Condoms can be male or female condoms 7. Ability to understand and willingness to sign (or assent when applicable) informed consent 1. Unwilling or unable to use birth control during participation in the study 2. History of invasive cervical cancer 3. Known allergy to 5-Fluorouracil 4. History of total hysterectomy 5. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient 6. Current use of chemotherapeutic medication or high dose steroids (10 mg prednisone per day or more (or equivalent steroids) Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 49 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/10/2023 KEMRI Scientific Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
Mbagathi rd Nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Safety Weekly until study exit at week 20
Secondary Outcome Uptake, tolerability, acceptability, adherence Weekly until study exit at week 20
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kenya Medicla Rsearch Institute RCTP Lumumba Subcounty Hospital Kisumu 40100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
UNC OBGYN Department 3009 Old Clinic Building, Campus Box 7570, Chapel Hill, NC 27599 Chapel Hill United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor UNC OBGYN Department 3009 Old Clinic Building, Campus Box 7570, Chapel Hill, NC 27599 Chapel Hill United States of America University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Chemtai Mungo Chemtai_mungo@med.unc.edu +19199666049 3009 Old Clinic Building, Campus Box 7570, Chapel Hill, NC 27599
City Postal code Country Position/Affiliation
Chapel Hill United States of America Principal Investigator
Role Name Email Phone Street address
Public Enquiries Cirilus Ogollah cogollah@kemri-rctp.org +254724717472 KEMRI RCTP Lumumba Subcounty Hospital
City Postal code Country Position/Affiliation
Kisumu Kenya Coinvestigator
Role Name Email Phone Street address
Scientific Enquiries Chemtai Mungo Chemtai_mungo@med.unc.edu +19199666049 3009 Old Clinic Building, Campus Box 7570, Chapel Hill, NC 27599
City Postal code Country Position/Affiliation
Chapel Hill United States of America Principal Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after de-identification (text,tables,figures, and appendices) will be available.The Clinical study report will be available for researchers who provide a methodologically sound proposal immediately after study publication.This data shall only be used to achieve aims in the approved protocols. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan Within 12 months of the studycompletion date Controlled
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information