Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among South African Women Living With HIV

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-22

Study Completion Date

2025-08-24

Brief Summary

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The purpose of this study is to explore whether an anti-cancer medication (5-fluorouracil cream) placed in the vagina after a surgical excision procedure is an acceptable and useful form of treatment for cervical precancer among the woman with HIV infection.

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Detailed Description

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There are currently no medical therapies recommended to promote the clearance of humanpapilloma virus (HPV) infection, regression of cervical dysplasia, or treatment of cervical intraepithelial neoplasia (CIN). Human immunodeficiency virus (HIV) -infected women are at higher risk of HPV infection, with rates as high as 45% - 90%. Despite being preventable, cytologic abnormalities, cervical precancer (high-grade cervical intraepithelial neoplasia \[CIN2/3\]), and invasive cervical cancer also occur more frequently in HIV infected women.

This study is testing whether topical 5-fluorouracil (5FU) can be used as a patient-controlled adjuvant treatment for cervical precancer (CIN2/3) to be self-administered after surgical excision to reduce the risk of persistent/recurrent CIN2/3 and progression to cervical cancer among HIV-infected women.

Conditions

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Cervical Cancer CIN2 CIN3 Human Immunodeficiency Virus Human Papillomavirus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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5 Fluorouracil Cream

The participants will receive 8 doses of intravaginal 5 Fluorouracil Cream.

Group Type EXPERIMENTAL

5 Fluorouracil (5 FU) Cream

Intervention Type DRUG

Intravaginal topical chemotherapy, 5-fluorouracil cream

Placebo Cream

The participants will receive 8 doses of intravaginal placebo cream.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intravaginal topical placebo cream

Interventions

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5 Fluorouracil (5 FU) Cream

Intravaginal topical chemotherapy, 5-fluorouracil cream

Intervention Type DRUG

Placebo

Intravaginal topical placebo cream

Intervention Type DRUG

Other Intervention Names

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Fluoroplex Efudex Carac

Eligibility Criteria

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Inclusion Criteria

* Confirmed HIV-1 infection
* On antiretroviral therapy (ART), for at least 90 days prior to enrollment
* Cervical biopsy demonstrating CIN2/3 within the preceding 120 days.

Exclusion Criteria

* pregnancy,
* breastfeeding,
* intend to become pregnant within 180 days of enrollment
* have an active sexually transmitted infection (women may participate once treated)
* have a surgically absent cervix
* have a history of anogenital (cervical, vaginal, vulvar, or anal) cancer or a biopsy suspicious for cervical cancer
* have a medical comorbidity that would interfere with study participation.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No