NCT00001998

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

November 1, 1992

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

NystatinAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

NystatinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Twelve Oaks Hosp

Houston, Texas, 77027, United States

Location

Related Publications (1)

  • 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)

    BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

Nystatin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1992-11

Locations

US(1)