A Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection.

Inclusion Criteria

Concurrent Medication:

Required:

• Aerosolized pentamidine (300 mg once a month) for PCP prophylaxis in patients with CD4 count <= 200 cells/mm3. (Patients with CD4 count > 200 cells/mm3 who are already on aerosolized pentamidine may continue such therapy at the discretion of the investigator.)

Allowed:

• Prophylaxis against Mycobacterium avium Complex in patients with CD4 count <= 100 cells/mm3.

Concurrent Treatment:

Allowed:

• Local treatment for Kaposi's sarcoma lesions with less than 25 percent increase in measurable disease.

Patients must have:

• HIV antibody positivity.
• Absolute CD4 count < 500 cells/mm3 on two determinations within 15 days prior to study entry.
• At least 6 months of prior zidovudine (AZT) therapy.
• No active opportunistic infection requiring ongoing therapy.
• Normal neurologic status by standard assessment.
• Life expectancy of at least 6 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

• Neoplasm other than basal cell carcinoma of the skin or stable untreated HIV-related Kaposi's sarcoma (provided there is no progression in the Kaposi's sarcoma beyond 25 percent of measurable disease).
• Clinically significant cardiac disease.
• Known hypersensitivity to polyene antibiotics.

Patients with the following prior conditions are excluded:

• History of myocardial infarction or arrhythmias.

Prior Medication:

Excluded within 2 weeks prior to study entry:

• Antiretroviral agents or interferons.
• Biological response modifiers.
• Corticosteroids.
• Cytotoxic chemotherapeutic agents.
• Drugs that can cause neutropenia or significant nephrotoxicity.
• Rifampin or rifampin derivatives.
• Systemic anti-infectives.

Prior Treatment:

Excluded within 2 weeks prior to study entry:

• Radiation therapy. Active drug or alcohol abuse.