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.