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

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
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: Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment

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

Page last updated: August 23, 2015

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