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

Inclusion Criteria 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. Exclusion Criteria 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.