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.

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety