Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among South African Women Living With HIV
- Conditions
- Cervical CancerCIN2CIN3Human Immunodeficiency VirusHuman Papillomavirus
- Interventions
- Drug: 5 Fluorouracil (5 FU) CreamDrug: Placebo
- Registration Number
- NCT05413811
- Lead Sponsor
- UNC Lineberger Comprehensive Cancer Center
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 180
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 5 Fluorouracil Cream 5 Fluorouracil (5 FU) Cream The participants will receive 8 doses of intravaginal 5 Fluorouracil Cream. Placebo Cream Placebo The participants will receive 8 doses of intravaginal placebo cream.
- Primary Outcome Measures
Name Time Method The number of subjects adhered to and retained in the study Up to 24 weeks 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.
The number of participants who found the intervention acceptable week 10 to week 24 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.
- Secondary Outcome Measures
Name Time Method The percentage of participants who demonstrate clearance of high-risk HPV 24 weeks 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.
The proportion of participants with CIN2 or CIN 3 that regressed to CIN1 24 weeks 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.
Trial Locations
- Locations (1)
Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital
🇿🇦Westdene, Johannesburg, South Africa