A Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection.
Completed · Phase 1
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002097
- Run by
- Argus Pharmaceuticals
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Twelve Oaks Hosp — Houston, Texas, United States
Full record on ClinicalTrials.gov
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