5-fluorouracil Following Cervical Intraepithelial Neoplasia Treatment Among HIV-positive Women in East Africa
- Conditions
- CIN 2/3HIV Infections
- Interventions
- Registration Number
- NCT05362955
- Lead Sponsor
- UNC Lineberger Comprehensive Cancer Center
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 12
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 5-FU Arm Intravaginal 5-Fluorouracil (5-FU) intravaginal 2g 5-fluorouracil cream in every two weeks
- Primary Outcome Measures
Name Time Method Safety of intravaginal 5-FU 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.
- Secondary Outcome Measures
Name Time Method Adherence of intravaginal 5-FU Up to 5 months Adherence will be evaluated by assessing the number of participants who are confirmed to use 75% or more of the 5-FU applications.
Uptake of intravaginal 5-FU Up to 20 weeks The proportion of eligible screened participants who agree to participate in the trial and applied intravaginal 5-FU as the study defined.
Tolerability of intravaginal 5-FU Up to 5 months 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.
Acceptability of intravaginal 5-FU Up to 20 weeks 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.
Trial Locations
- Locations (1)
Lumumba Sub-County Hospital KEMRI- Research Care Training Program (RCTP) Building
🇰🇪Kisumu, Kenya