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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-26

Study Completion Date

2024-02-01

Brief Summary

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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).

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Detailed Description

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Conditions

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CIN 2/3 HIV Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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5-FU Arm

intravaginal 2g 5-fluorouracil cream in every two weeks

Group Type EXPERIMENTAL

Intravaginal 5-Fluorouracil (5-FU)

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes