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

• Sponsor: UNC Lineberger Comprehensive Cancer Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05362955
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 3.6

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
CIN 2/3; HIV Infections	Drug: Intravaginal 5-Fluorouracil (5-FU)	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 5-fluorouracil Following Cervical Intraepithelial Neoplasia Treatment Among HIV-positive Women in East Africa
• Anticipated Study Start Date: Dec 30, 2022
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 5-FU Arm intravaginal 2g 5-fluorouracil cream in every two weeks	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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 49 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UNC Project, Kamuzu Central Hospital	Lilongwe		Malawi

Sponsors and Collaborators

• UNC Lineberger Comprehensive Cancer Center

Investigators

• Principal Investigator: Chemtai Mungo, MD, MPH, Assistant Professor, Obstetrics and Gynecology

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Publications

None provided.

• Responsible Party: UNC Lineberger Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT05362955
• Other Study ID Numbers: UNCPM22120
• First Posted: May 5, 2022
• Last Update Posted: Jul 8, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by UNC Lineberger Comprehensive Cancer Center: cervical cancer; CIN 2/3; 5-Fluorouracil
• Additional relevant MeSH terms: Cervical Intraepithelial Neoplasia; Fluorouracil

Study Results

No Results Posted as of Jul 8, 2022