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

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

Sex: Female

Ages: 18 Years – N/A

Healthy volunteers: No

Phase: NA

Enrollment: 180

Sponsor: UNC Lineberger Comprehensive Cancer Center

Location: Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital Westdene Johannesburg

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.

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05413811). StuddyBuddy aggregates publicly available trial information.