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

Phase 1

Completed

• Conditions: HIV Infections; CIN 2/3

• Registration Number: NCT05362955
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-5-2
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

Subjects must meet all of the inclusion criteria to participate in this study.<br><br>Inclusion Criteria:<br><br> 1. HIV-positive women<br><br> 2. Age 18 years - 49 years at enrollment<br><br> 3. Documentation of a biopsy-confirmed CIN2 or CIN3<br><br> 4. Within 4-12 weeks after primary treatment for CIN2 or CIN3<br><br> 5. Negative pregnancy test at screening and agreement to use dual form of contraception<br> (hormonal birth control, intrauterine device, or tubal ligation - plus condoms)<br> during the study duration, if of childbearing age.<br><br> 6. Agree to use dual contraception if of childbearing age (hormonal method,<br> intrauterine or implant device, or tubal ligation - plus condoms) for duration of<br> study<br><br> 7. Ability to understand and willingness to sign (or assent when applicable) informed<br> consent<br><br>Exclusion Criteria:<br><br> 1. HIV-negative women<br><br> 2. Pregnant or planning pregnancy within the next 6 months or breastfeeding<br><br> 3. Unwilling or unable to use birth control during participation in the study<br><br> 4. History of invasive cervical cancer<br><br> 5. Untreated vaginal or vulvar dysplasia<br><br> 6. Known allergy to 5-Fluorouracil<br><br> 7. History of total hysterectomy<br><br> 8. Presence of a condition or abnormality that in the opinion of the Investigator would<br> compromise the safety of the patient<br><br> 9. Current use of chemotherapeutic medication or high dose steroids (10 mg prednisone<br> per day or more (or equivalent steroids)

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of intravaginal 5-FU

Secondary Outcome Measures

Name	Time	Method
Tolerability of intravaginal 5-FU;Adherence of intravaginal 5-FU;Acceptability of intravaginal 5-FU;Uptake of intravaginal 5-FU