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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Nystatin
Sponsored by
Argus Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Nystatin, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Argus Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00002097
Brief Title
A Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection.
Official Title
A Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection.
Study Type
Interventional

2. Study Status

Record Verification Date
April 1994
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Argus Pharmaceuticals

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Nystatin, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Nystatin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Twelve Oaks Hosp
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
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Learn more about this trial

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

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