5-fluorouracil Following Cervical Intraepithelial Neoplasia Treatment Among HIV-positive Women in East Africa
Primary Purpose
CIN 2/3, HIV Infections
Status
Recruiting
Phase
Phase 1
Locations
Kenya
Study Type
Interventional
Intervention
Intravaginal 5-Fluorouracil (5-FU)
Sponsored by
About this trial
This is an interventional treatment trial for CIN 2/3 focused on measuring cervical cancer, CIN 2/3, 5-Fluorouracil
Eligibility 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)
Sites / Locations
- Lumumba Sub-County Hospital KEMRI- Research Care Training Program (RCTP) BuildingRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
5-FU Arm
Arm Description
intravaginal 2g 5-fluorouracil cream in every two weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT05362955
First Posted
May 2, 2022
Last Updated
June 30, 2023
Sponsor
UNC Lineberger Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT05362955
Brief Title
5-fluorouracil Following Cervical Intraepithelial Neoplasia Treatment Among HIV-positive Women in East Africa
Official Title
5-fluorouracil Following Cervical Intraepithelial Neoplasia Treatment Among HIV-positive Women in East Africa
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CIN 2/3, HIV Infections
Keywords
cervical cancer, CIN 2/3, 5-Fluorouracil
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
5-FU Arm
Arm Type
Experimental
Arm Description
intravaginal 2g 5-fluorouracil cream in every two weeks
Intervention Type
Drug
Intervention Name(s)
Intravaginal 5-Fluorouracil (5-FU)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety of intravaginal 5-FU
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.
Time Frame
Up to 5 months
Secondary Outcome Measure Information:
Title
Tolerability of intravaginal 5-FU
Description
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.
Time Frame
Up to 5 months
Title
Adherence of intravaginal 5-FU
Description
Adherence will be evaluated by assessing the number of participants who are confirmed to use 75% or more of the 5-FU applications.
Time Frame
Up to 5 months
Title
Acceptability of intravaginal 5-FU
Description
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.
Time Frame
Up to 20 weeks
Title
Uptake of intravaginal 5-FU
Description
The proportion of eligible screened participants who agree to participate in the trial and applied intravaginal 5-FU as the study defined.
Time Frame
Up to 20 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rabab Husain
Phone
919-962-4880
Email
rabab_husain@med.unc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chemtai Mungo, MD, MPH
Organizational Affiliation
Assistant Professor, Obstetrics and Gynecology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lumumba Sub-County Hospital KEMRI- Research Care Training Program (RCTP) Building
City
Kisumu
ZIP/Postal Code
614-40100
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth A Bukusi, MD
Phone
254 733617503
Email
ebukusi@rctp.or.ke
First Name & Middle Initial & Last Name & Degree
Rachel Wakisha
Email
rmwakisha@rctp.or.ke
First Name & Middle Initial & Last Name & Degree
Elizabeth A Bukusi, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Links:
URL
http://unclineberger.org/patientcare/clinical-trials/clinical-trials
Description
University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials
Learn more about this trial
5-fluorouracil Following Cervical Intraepithelial Neoplasia Treatment Among HIV-positive Women in East Africa
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