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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the clinical toxicity, safety, and maximum tolerated dose (MTD) of intravenous nystatin in patients with HIV infection. To evaluate the potential anti-HIV activity and clinical pharmacology of intravenous nystatin.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Argus Pharmaceuticals
• Treatments: Nystatin

Criteria

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.