Clinical trial NCT05413811: Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among South African Women Living With HIV
Official title: Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among South African Women Living With HIV
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cervical Cancer
CIN2
CIN3
Human Immunodeficiency Virus
Human Papillomavirus
Keywords: 5-fluorouracil cream
Loop electrosurgical excision
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-06-10
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The number of subjects adhered to and retained in the study
timeFrame: Up to 24 weeks
measure: The number of participants who found the intervention acceptable
timeFrame: week 10 to week 24
Secondary outcomes:
measure: The proportion of participants with CIN2 or CIN 3 that regressed to CIN1
timeFrame: 24 weeks
measure: The percentage of participants who demonstrate clearance of high-risk HPV
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Westdene
country: South Africa
facility: Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital
state: Johannesburg
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Carla Chibwesha, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: