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

UNC Lineberger Comprehensive Cancer Center180 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

180

Conditions

Cervical Cancer CIN2 CIN3 Human Immunodeficiency Virus Human Papillomavirus

Interventions

5 Fluorouracil (5 FU) CreamDRUG

Intravaginal topical chemotherapy, 5-fluorouracil cream

PlaceboDRUG

Intravaginal topical placebo cream

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital

Westdene, Johannesburg, South Africa

Outcomes

Primary Outcomes

The number of subjects adhered to and retained in the study

The feasibility of the combination of surgical excision followed by adjuvant 5FU for the treatment of CIN2/3 among HIV-infected women will be evaluated using the number of subjects adhered to and retained in the study.

Time frame: Up to 24 weeks

The number of participants who found the intervention acceptable

The acceptability of the combination of surgical excision followed by adjuvant 5FU for the treatment of CIN2/3 among HIV-infected women will be assessed through a participant questionnaire administered at midline and end of the study.

Time frame: week 10 to week 24

Secondary Outcomes

The proportion of participants with CIN2 or CIN 3 that regressed to CIN1

Efficacy of combination treatment for CIN2/3 will be assessed as the number of subjects with CIN2 or CIN3 regressed to CIN1 or normal histology.

Time frame: 24 weeks

The percentage of participants who demonstrate clearance of high-risk HPV

Efficacy of combination treatment for HPV will be assessed as the percentage of women in each study arm who demonstrate clearance of high-risk HPV between baseline and 24 weeks.

Time frame: 24 weeks

Data from ClinicalTrials.gov

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