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).