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

June 23, 2005 updated by: Argus Pharmaceuticals
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77027
        • Twelve Oaks Hosp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Argus Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

November 1, 1992

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 103A
  • AR-90-01-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Nystatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe