Official Title: “A Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection.”

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.

Study Type: Interventional

Study Design: Treatment, Dose Comparison, Pharmacokinetics Study

Cohorts of three patients each are treated at escalating doses of intravenous nystatin, administered every other day, until the MTD is reached. Each cohort is observed for toxicity for at least 2 weeks before escalation in subsequent patient cohorts is initiated.

Intervention(s) in this Clinical Trial

• Drug: Nystatin

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Argus Pharmaceuticals

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002097

Study ID Number: 103B

ClinicalTrials.gov Identifier: NCT00002097

Health Authority: United States: Food and Drug Administration