NCT00002304

Brief Summary

To compare the safety, tolerance, and effectiveness of fluconazole and ketoconazole in the treatment of candidal esophagitis in immunocompromised patients.

Trial Health

85
On Track

Trial Health Score

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

Geographic Reach
2 countries

42 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

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

February 1, 1990

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Keywords

AIDS-Related Opportunistic InfectionsImmune ToleranceKetoconazoleEsophagitisFluconazoleAcquired Immunodeficiency SyndromeCandidiasis, Oral

Interventions

Eligibility Criteria

Age13 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Prior Medication:
  • Allowed:
  • Cyclosporin if levels can be monitored for proper cyclosporin dose adjustment.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following are excluded:
  • Evidence of noncandidal systemic fungal infections.
  • Leukopenia (white blood cell count less than 1000/mm3), or expected to develop leukopenia during the study.
  • Other condition known to be associated with poor ketoconazole absorption, e.g., hypochlorhydria.
  • Leukemia requiring chemotherapy.
  • Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment.
  • Concurrent Medication:
  • Excluded:
  • Warfarin.
  • Immunostimulants.
  • Interferon.
  • Oral or topical antifungal agents.
  • Concurrent Treatment:
  • Excluded:
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (42)

Good Samaritan Med Ctr

Phoenix, Arizona, 85006, United States

Location

Arkansas Children's Hosp

Little Rock, Arkansas, 72202, United States

Location

Los Angeles County - USC Med Ctr

Los Angeles, California, 90033, United States

Location

Eisenhower Med Ctr

Rancho Mirage, California, 92270, United States

Location

ViRx Inc

San Francisco, California, 94103, United States

Location

UCSF Hosp

San Francisco, California, 941430654, United States

Location

George Washington Univ Med Ctr

Washington D.C., District of Columbia, 20037, United States

Location

Regional Oncology Ctr

Daytona Beach, Florida, 32015, United States

Location

Ctr for Special Immunology

Fort Lauderdale, Florida, 33308, United States

Location

Mem Hosp Hollywood

Hollywood, Florida, 33021, United States

Location

Med Ctr Clinic

Pensacola, Florida, 325241151, United States

Location

St Petersburg Med Clinics

St. Petersburg, Florida, 33705, United States

Location

Georgia Baptist Med Ctr

Atlanta, Georgia, 30338, United States

Location

DeKalb Gen Hosp

Decatur, Georgia, 30033, United States

Location

Gwinnett Med Ctr

Lawrenceville, Georgia, 30245, United States

Location

Atlanta Hosp

Riverdale, Georgia, 30274, United States

Location

Clayton Gen Hosp

Riverdale, Georgia, 30274, United States

Location

Dr Winkler Weinberg

Roswell, Georgia, 30076, United States

Location

Univ Hosp

Boston, Massachusetts, 02118, United States

Location

Baystate Med Ctr of Springfield

Springfield, Massachusetts, 01199, United States

Location

Leila Hosp and Health Care Ctr

Battle Creek, Michigan, 49016, United States

Location

Harper Hosp

Detroit, Michigan, 48201, United States

Location

Butterworth Hosp

Grand Rapids, Michigan, 49503, United States

Location

Holland Community Hosp

Holland, Michigan, 49423, United States

Location

Munson Med Ctr

Traverse City, Michigan, 49684, United States

Location

Dr Eugene Speck

Las Vegas, Nevada, 89109, United States

Location

Univ of New Mexico School of Medicine

Albuquerque, New Mexico, 87131, United States

Location

SUNY / Health Sciences Ctr at Brooklyn

Brooklyn, New York, 11203, United States

Location

Roswell Park Memorial Institute

Buffalo, New York, 14263, United States

Location

Cornell Univ Med Ctr

New York, New York, 10021, United States

Location

Bowman Gray School of Medicine / North Carolina Baptist Hosp

Winston-Salem, North Carolina, 27103, United States

Location

Buckley Braffman Stern Med Associates

Philadelphia, Pennsylvania, 19107, United States

Location

Wilson Brailsford Clinic

Spartanburg, South Carolina, 29304, United States

Location

Baroness Erlanger Hosp

Chattanooga, Tennessee, 37403, United States

Location

Univ of Tennessee

Memphis, Tennessee, 38163, United States

Location

Univ TX Galveston Med Branch

Galveston, Texas, 77550, United States

Location

Audie L Murphy Veterans Administration Hosp

San Antonio, Texas, 78284, United States

Location

Univ TX San Antonio Health Science Ctr

San Antonio, Texas, 78284, United States

Location

Infectious Disease Physicians Inc

Annandale, Virginia, 22203, United States

Location

McGuire Virginia Med Ctr

Richmond, Virginia, 23249, United States

Location

Virginia Mason Med Ctr

Seattle, Washington, 98101, United States

Location

Henderson Gen Hosp

Hamilton, Ontario, Canada

Location

Related Publications (1)

  • Laine L, Dretler RH, Conteas CN, Tuazon C, Koster FM, Sattler F, Squires K, Islam MZ. Fluconazole compared with ketoconazole for the treatment of Candida esophagitis in AIDS. A randomized trial. Ann Intern Med. 1992 Oct 15;117(8):655-60. doi: 10.7326/0003-4819-117-8-655.

    PMID: 1308663BACKGROUND

MeSH Terms

Conditions

CandidiasisHIV InfectionsAIDS-Related Opportunistic InfectionsEsophagitisAcquired Immunodeficiency SyndromeCandidiasis, Oral

Interventions

KetoconazoleFluconazole

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesOpportunistic InfectionsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisSlow Virus DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTriazolesAzoles

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: 1990-02

Locations