Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among South African Women Living With HIV (ACT2)

UNC Lineberger Comprehensive Cancer Center

Status: Active, not recruiting

Conditions: Human Immunodeficiency Virus; CIN2; CIN3; Human Papillomavirus; Cervical Cancer

Treatments: Drug: Placebo; Drug: 5 Fluorouracil (5 FU) Cream

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05413811

1R01CA250850-01 (U.S. NIH Grant/Contract)

IGHID12046

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 180 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 2 patient groups, including a placebo group

5 Fluorouracil Cream

Experimental group

Description:

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

Treatment:

Drug: 5 Fluorouracil (5 FU) Cream

Placebo Cream

Placebo Comparator group

Description:

The participants will receive 8 doses of intravaginal placebo cream.

Treatment:

Drug: Placebo