Chemoprevention of Anal Neoplasia Arising Secondary to Anogenital Human Papillomavirus Infection in Persons With HIV Infection.

Inclusion Criteria Concurrent Medication: Allowed: PCP prophylaxis (required for patients with CD4 count < 200 cells/mm3). Chemoprophylaxis for candidiasis and herpes simplex. Metronidazole for up to 14 days. Erythropoietin. Patients must have: HIV seropositivity. NO active opportunistic infection requiring treatment with prohibited drugs. Phase I - Current grade 1 AIN (i.e., low grade SIL) OR treated or untreated grade 2 or 3 AIN (i.e., high grade SIL). Phase II - Prior histologically confirmed grade 2 or 3 AIN / high grade SIL, with ablative therapy within the past 30-90 days. Capability of complying with study protocol. NOTE: The terms condyloma, grade 1 AIN, and low grade SIL are interchangeable. Grade 2 or 3 AIN is interchangeable with high grade SIL. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Active medical problems for which the patient is undergoing evaluations or for which prohibited therapy is required. Other active malignancies requiring systemic therapy. Significant symptomatic cardiac disease. NOTE: Patients with malignancies being managed with local therapy (e.g., Kaposi's sarcoma, basal cell carcinoma) may enroll at the discretion of the site investigator. Concurrent Medication: Excluded: G-CSF (filgrastim). Myelosuppressive antibiotics (except co-trimoxazole for PCP prophylaxis). Corticosteroids. Biologic response modifiers. Cytotoxic chemotherapy. Concurrent Treatment: Excluded: Radiation therapy. Patients with the following prior conditions are excluded: History of ventricular arrhythmias or myocardial infarction. Prior Medication: Excluded within 20 days prior to study entry: G-CSF (filgrastim). Myelosuppressive antibiotics (except co-trimoxazole for PCP prophylaxis). Corticosteroids. Biologic response modifiers. Cytotoxic chemotherapy. Prior Treatment: Excluded within 20 days prior to study entry: Radiation therapy. Excluded within 14 days prior to study entry: Transfusion. Active substance abuse or illegal drug use (alcohol consumption is strongly discouraged).