Comparison of Anti HIV Drugs Used Alone or in Combination With Cytosine Arabinoside to Treat Progressive Multifocal Leukoencephalopathy (PML) in HIV-Infected Patients

Inclusion Criteria

Concurrent Medication:

Allowed:

• Local intralesional chemotherapy for mucocutaneous Kaposi's sarcoma.
• Topical antifungals, clotrimazole, ketoconazole, fluconazole, and amphotericin B for treatment of mucosal and esophageal candidiasis.
• Foscarnet for newly developed CMV infection, only after discussion with the protocol chair.
• Prophylactic and maintenance therapy for other opportunistic infections, provided patients are considered clinically stable.
• No more than 1000 mg/day acyclovir for herpes simplex.
• Antibiotics for bacterial infections as clinically indicated.
• Antipyretics, analgesics, and antiemetics.

Concurrent Treatment:

Allowed:

• Local radiation therapy for mucocutaneous Kaposi's sarcoma.

Patients must have:

• HIV infection.
• Confirmed PML.
• No other current active opportunistic infections requiring systemic therapy.
• Life expectancy of at least 3 months.

NOTE:

• A durable power of attorney is recommended where severe neurologic or psychiatric impairment can be foreseen while the patient is on study.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Current active cryptococcal meningitis, cytomegaloviral encephalitis, toxoplasmosis encephalitis, CNS lymphoma, or neurosyphilis.

NOTE:

• Patients on maintenance therapy for cryptococcal meningitis or toxoplasmosis encephalitis that has been stable for 4 months are permitted.
• Conditions that seriously increase risk of a surgical procedure (e.g., coagulopathy, severe thrombocytopenia).
• Any other disease that would interfere with evaluation of the patient.
• Other life-threatening complications likely to cause death in < 3 months.

Concurrent Medication:

Excluded:

• Ganciclovir.
• Interferon.
• Systemic chemotherapy other than Ara-C (unless specifically allowed).
• Antiretroviral medications other than AZT, ddI, or ddC.

Patients with the following prior conditions are excluded:

History of allergy or intolerance to G-CSF.

Prior Medication:

Excluded:

• Any prior Ara-C.

Excluded within 14 days prior to study:

• Ganciclovir or foscarnet.
• Interferon.
• Antiretroviral medications other than AZT, ddI, or ddC.
• Experimental medications for treatment of PML.