NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

CompletedNA

Sponsor: UNC Lineberger Comprehensive Cancer Center

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

Interventions: 5 Fluorouracil (5 FU) Cream, Placebo

Countries: South Africa

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 overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (1)

Westdene, Johannesburg, South Africa