5-fluorouracil Following Cervical Intraepithelial Neoplasia Treatment Among HIV-positive Women in East Africa

HIV Infections Clinical Trial

Official title:

5-fluorouracil Following Cervical Intraepithelial Neoplasia Treatment Among HIV-positive Women in East Africa

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05362955
• Other study ID #: UNCPM22120
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: April 26, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: February 2024
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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)

Related Conditions & MeSH terms

• CIN 2/3
• HIV Infections
• Uterine Cervical Dysplasia

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Kenya	Lumumba Sub-County Hospital KEMRI- Research Care Training Program (RCTP) Building	Kisumu

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 5 months
Secondary	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.	Up to 5 months
Secondary	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.	Up to 5 months
Secondary	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.	Up to 20 weeks
Secondary	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.	Up to 20 weeks

External Links

•   University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials