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).

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