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Pharmacokinetics of Nystatin LF I.V. in Patients With Acquired Immune Deficiency Syndrome-Related Complex (ARC)

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
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 Patients must have the following: Positive HIV antibody test. Diagnosis of AIDS-related complex (ARC). CD4+ cell count between 100 and 300 cells/mm3. Estimated life expectancy of at least 6 months. Normal neurological status. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Active opportunistic infection requiring ongoing therapy except patients being treated topically for oral thrush. Patients with the following are excluded: Active opportunistic infection. Known hypersensitivity to polyene antibiotics. Unwillingness to sign an informed consent or to be in compliance of protocol requirements. Prior Medication: Excluded within 72 hours of study entry: Biologic response modifier agents. Corticosteroids. Cytotoxic chemotherapeutic agents. Potential nephrotoxins. Potential neutropenic agents. Rifampin or rifampin derivatives. Systemic anti-infectives. Phenytoin or barbiturates (inducers of microsomal enzymes). All systemic medications. Prior Treatment: Excluded within 72 hours prior to study entry: Radiation therapy. Active alcohol or drug abuse unless they have been off drugs and/or alcohol for two weeks prior to start of study.

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
NCT00001998
Brief Title
Pharmacokinetics of Nystatin LF I.V. in Patients With Acquired Immune Deficiency Syndrome-Related Complex (ARC)
Official Title
Pharmacokinetics of Nystatin LF I.V. in Patients With Acquired Immune Deficiency Syndrome-Related Complex (ARC)
Study Type
Interventional

2. Study Status

Record Verification Date
November 1992
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 define the pharmacokinetic characteristics of Nystatin LF IV (intravenous) in human subjects with AIDS-related complex (ARC) after administration of a single IV dose at each of 4 dose levels.

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
Not Applicable

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 Patients must have the following: Positive HIV antibody test. Diagnosis of AIDS-related complex (ARC). CD4+ cell count between 100 and 300 cells/mm3. Estimated life expectancy of at least 6 months. Normal neurological status. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Active opportunistic infection requiring ongoing therapy except patients being treated topically for oral thrush. Patients with the following are excluded: Active opportunistic infection. Known hypersensitivity to polyene antibiotics. Unwillingness to sign an informed consent or to be in compliance of protocol requirements. Prior Medication: Excluded within 72 hours of study entry: Biologic response modifier agents. Corticosteroids. Cytotoxic chemotherapeutic agents. Potential nephrotoxins. Potential neutropenic agents. Rifampin or rifampin derivatives. Systemic anti-infectives. Phenytoin or barbiturates (inducers of microsomal enzymes). All systemic medications. Prior Treatment: Excluded within 72 hours prior to study entry: Radiation therapy. Active alcohol or drug abuse unless they have been off drugs and/or alcohol for two weeks prior to start of study.
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, Crofoot GE, Lenk R, Hayman A, Rosenblum M, Lopez-Berestein G. A phase 1 single dose safety evaluation and pharmacokinetic (Pkc) study of nystatin-liposomal formulation nystatin-LF i.v. in patients with HIV infection. Int Conf AIDS. 1992 Jul 19-24;8(3):127 (abstract no PuB 7473)
Results Reference
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Pharmacokinetics of Nystatin LF I.V. in Patients With Acquired Immune Deficiency Syndrome-Related Complex (ARC)

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