NCT00002112

Brief Summary

To compare the efficacy, safety, and toleration of fluconazole as a single daily oral suspension for 14 days versus nystatin oral suspension 4 times daily for 14 days in the treatment of oropharyngeal candidiasis in patients with AIDS or HIV infection.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

5 active sites

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

April 1, 1996

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Candidiasis, OralHIV Infections

Keywords

NystatinFluconazoleAcquired Immunodeficiency SyndromeAIDS-Related ComplexCandidiasis, Oral

Interventions

NystatinDRUG
FluconazoleDRUG

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Phenytoin.
  • Oral hypoglycemics.
  • Coumarin-type anticoagulants.
  • Cyclosporine.
  • Patients must have:
  • ARC or AIDS.
  • Signs of oropharyngeal candidiasis (i.e., typical white plaques) with some associated symptoms.
  • Confirmation of diagnosis by microscopic exam and culture of organism.
  • Life expectancy of at least 4 weeks.
  • NOTE:
  • Patients with signs or symptoms of esophagitis (e.g., odynophagia) are not eligible unless esophagoscopy is performed and results are negative.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following conditions are excluded:
  • Unable to tolerate oral medication.
  • Concurrent enrollment on another experimental trial of approved or non-approved drugs or systemic compounds (without approval of Pfizer clinical monitor).
  • Concurrent Medication:
  • Excluded:
  • Antifungal agents other than study drugs.
  • Other experimental medications.
  • Patients with the following prior conditions are excluded:
  • Known history of intolerance or allergy to imidazoles or triazoles or the polyene components of nystatin.
  • Prior Medication:
  • Excluded:
  • Other antifungal agents within the past 3 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

California Med Research Group

Fresno, California, 93726, United States

Location

UCSF Hosp

San Francisco, California, 94143, United States

Location

Johns Hopkins School of Medicine

Baltimore, Maryland, 21205, United States

Location

Med College of Pennsylvania

Philadelphia, Pennsylvania, 19129, United States

Location

Hampton Roads Med Specialists

Hampton, Virginia, 23666, United States

Location

MeSH Terms

Conditions

Candidiasis, OralHIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

NystatinFluconazole

Condition Hierarchy (Ancestors)

CandidiasisMycosesBacterial Infections and MycosesInfectionsMouth DiseasesStomatognathic DiseasesBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1996-04

Locations

US(5)