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Spots Global Cancer Trial Database for A Phase III Randomized Trial of Topical Vaginal Fluorouracil (5-Fluorouracil, 5-FU) Maintenance Therapy Versus Observation After Standard Treatment for High-Grade Cervical Dysplasia in HIV-Infected Women

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Trial Identification

Brief Title: A Phase III Randomized Trial of Topical Vaginal Fluorouracil (5-Fluorouracil, 5-FU) Maintenance Therapy Versus Observation After Standard Treatment for High-Grade Cervical Dysplasia in HIV-Infected Women

Official Title: A Phase III Randomized Trial of Topical Vaginal Fluorouracil (5-Fluorouracil, 5-FU) Maintenance Therapy Versus Observation After Standard Treatment for High-Grade Cervical Dysplasia in HIV-Infected Women

Study ID: NCT00000758

Interventions

Fluorouracil

Study Description

Brief Summary: To determine the efficacy and safety of intravaginal fluorouracil administered as prophylaxis in HIV-infected women who have received standard ablative therapy (surgery) for high-grade cervical dysplasia (pre-cancer of the cervix; cervical intraepithelial neoplasia). To correlate time to recurrence of cervical dysplasia with T-cell function. Women with HIV infection are at greater risk for cervical dysplasia. Because of the likelihood that untreated or recurrent cervical dysplasia may progress to invasive cancer, there is an urgent need to develop appropriate therapies.

Detailed Description: Women with HIV infection are at greater risk for cervical dysplasia. Because of the likelihood that untreated or recurrent cervical dysplasia may progress to invasive cancer, there is an urgent need to develop appropriate therapies. Patients are randomized to receive either intravaginal fluorouracil or no treatment (observation only). Fluorouracil cream is self-administered via applicator at biweekly intervals for 6 months. Patients are evaluated for recurrent cervical dysplasia by cytology and colposcopy with or without biopsy.

Eligibility

Minimum Age: 13 Years

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Usc La Nichd Crs, Los Angeles, California, United States

Univ. of Miami AIDS CRS, Miami, Florida, United States

Northwestern University CRS, Chicago, Illinois, United States

Cook County Hosp. CORE Ctr., Chicago, Illinois, United States

Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease, Chicago, Illinois, United States

Tulane/LSU Maternal/Child CRS, New Orleans, Louisiana, United States

Johns Hopkins Adult AIDS CRS, Baltimore, Maryland, United States

Bmc Actg Crs, Boston, Massachusetts, United States

Beth Israel Deaconess Med. Ctr., ACTG CRS, Boston, Massachusetts, United States

Children's Hospital of Michigan NICHD CRS, Detroit, Michigan, United States

NJ Med. School CRS, Newark, New Jersey, United States

Bronx-Lebanon Hosp. IMPAACT CRS, Bronx, New York, United States

SUNY - Buffalo, Erie County Medical Ctr., Buffalo, New York, United States

Memorial Sloan-Kettering Cancer Ctr., New York, New York, United States

Univ. of Rochester ACTG CRS, Rochester, New York, United States

SUNY Upstate Med. Univ., Dept. of Peds., Syracuse, New York, United States

Unc Aids Crs, Chapel Hill, North Carolina, United States

Univ. of Cincinnati CRS, Cincinnati, Ohio, United States

UW School of Medicine - CHRMC, Seattle, Washington, United States

Puerto Rico-AIDS CRS, San Juan, , Puerto Rico

San Juan City Hosp. PR NICHD CRS, San Juan, , Puerto Rico

Contact Details

Name: Maiman M

Affiliation:

Role: STUDY_CHAIR

Name: Watts DH

Affiliation:

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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