Spots Global Cancer Trial Database for Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among South African Women Living With HIV

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: 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 ID: NCT05413811

Conditions

Cervical Cancer

CIN2

CIN3

Human Immunodeficiency Virus

Human Papillomavirus

Interventions

5 Fluorouracil (5 FU) Cream

Placebo

Study Description

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.