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

Completed · Phase 3

Conditions studied: HIV Infections, Cervix, Dysplasia

In brief

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.

Key facts

Study ID

NCT00000758

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

158

Expected to finish

1998-04-01

Last updated by the study team

2021-11-04

Who can join

Age: 13 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication:
• Allowed:
• Antiretrovirals (AZT, ddI, ddC) and immunomodulators (interferon and interleukin).
• Prophylaxis or treatment for opportunistic infections.
• Vaginal antifungal agents or other indicated vaginal medications (although not permitted on day of fluorouracil application).
• Contraceptives.
• Acyclovir (prophylaxis or treatment) in patients with a history of primary or recurrent genital herpes.
• Patients must have:
• HIV infection.
• Prior cervical dysplasia (grade II or III cervical intraepithelial neoplasia) successfully treated with an ablative procedure within the past 12 weeks.
• Patients less than 18 years of age must have consent of parent or guardian.

You may not qualify if…

• Co-existing Condition:
• Patients with the following symptoms and conditions are excluded:
• Untreated or persistent vaginal or vulvar dysplasia.
• Colposcopy or biopsy inconclusive or positive for dysplasia.
• Active genital ulcerative disease such as syphilitic chancre or herpes ulcer.
• Adenocarcinoma in situ.
• Concurrent Medication:
• Excluded:
• Cytotoxic chemotherapy for malignancy.
• High-dose steroids (> 10 mg/day prednisone or its steroid equivalent).
• Patients with the following prior conditions are excluded:
• Malignancy requiring cytotoxic chemotherapy within the 3 months prior to study entry.
• Prior hysterectomy.
• History of allergic reaction or severe hypersensitivity to fluorouracil.
• Prior Medication:
• Excluded:
• Fluorouracil (systemic or topical) within 3 months prior to study entry.

Where it is running

• 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
• 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
• Bronx-Lebanon Hosp. IMPAACT CRS — The Bronx, 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

Full record on ClinicalTrials.gov

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