A Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection.
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Nystatin, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
Eligibility 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.
Sites / Locations
- Twelve Oaks Hosp