A Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection.
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Nystatin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Argus Pharmaceuticals
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.
Clinical Details
Official title: A Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection.
Study design: Treatment, Dose Comparison, Pharmacokinetics Study
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Twelve Oaks Hosp, Houston, Texas 77027, United States
Additional Information
Related publications: Rios A, Brewton G, Crofoot G, Quesada J, Lenk R, Lopez-Berenstein G. A phase I-II clinical study of Nystatin-LF IV in patients with HIV infections. Int Conf AIDS. 1993 Jun 6-11;9(1):483 (abstract no PO-B26-2089)
Last updated: June 23, 2005
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