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A Comparison of the Safety and Effectiveness of Fluconazole or Clotrimazole in the Treatment of Fungal Infections of the Mouth and Throat in Patients With AIDS

This study has been completed.

Sponsored by: Pfizer
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002282
  Purpose

To compare the efficacy, safety, and tolerance of fluconazole single daily capsule for 14 days versus clotrimazole troche 5 x daily for 14 days in the treatment of oropharyngeal candidiasis in patients with AIDS.


Condition Intervention
Candidiasis, Oral
HIV Infections
Drug: Clotrimazole
Drug: Fluconazole

MedlinePlus related topics:   AIDS    Yeast Infections   

Drug Information available for:   Clotrimazole    Miconazole    Miconazole nitrate    Tioconazole    Fluconazole   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Randomized Multicenter Study of the Efficacy, Safety, and Toleration of Fluconazole or Clotrimazole Troches in the Treatment of Patients With Oropharyngeal Candidiasis in Association With the Acquired Immunodeficiency Syndrome
  Eligibility
Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Cimetidine.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

  • Known history of intolerance or allergy to imidazoles or triazoles, or the non-azole components of clotrimazole troches (dextrose, cellulose, povidone, magnesium stearate).
  • Moderate or severe liver disease defined by specified lab values.

Concurrent Medication:

Excluded pending results of phase I studies to determine whether interaction between fluconazole and these agents occurs:

  • Barbiturates.
  • Phenytoin.
  • Coumarin-type anticoagulants.
  • Rifampin.
  • Oral hypoglycemics.
  • Cyclosporin.

Patients with the following are excluded:

  • Known history of intolerance or allergy to imidazoles or triazoles, or the non-azole components of clotrimazole troches (dextrose, cellulose, povidone, magnesium stearate).
  • Unable to tolerate oral medication.
  • Moderate or severe liver disease defined by specified lab values.
  • Life expectancy < 4 weeks.
  • Unable or unwilling to be followed at the same center for the conduct of this study.

Prior Medication:

Excluded within 3 days of study entry:

  • Other antifungal agents.
  • Excluded pending results of phase I studies to determine whether interaction between fluconazole and these agents occurs:
  • Barbiturates.
  • Phenytoin.
  • Coumarin-type anticoagulants.
  • Rifampin.
  • Oral hypoglycemics.
  • Cyclosporin.

Patients meeting CDC criteria for diagnosis of AIDS, or having serologic or virologic evidence of HIV infection (but without AIDS-defining opportunistic infections as of yet).

  • Patients who have given informed consent in writing to their participation in the study.
  • Patients with signs of oropharyngeal candidiasis, i.e., with typical white plaques.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002282

Locations
United States, California
Davies Med Ctr    
      San Francisco, California, United States, 94114
Summitt Med Ctr / San Francisco Gen Hosp    
      Oakland, California, United States, 94609
Dr Robert Larsen    
      Los Angeles, California, United States, 90033
UCSF Hosp    
      San Francisco, California, United States, 941430654
United States, Connecticut
Saint Raphael's Hosp    
      New Haven, Connecticut, United States, 06511
United States, District of Columbia
George Washington Univ Med Ctr    
      Washington, District of Columbia, United States, 20037
United States, Maryland
Johns Hopkins Hosp    
      Baltimore, Maryland, United States, 21205
United States, Massachusetts
Univ Hosp    
      Boston, Massachusetts, United States, 02118
United States, Missouri
Washington Univ School of Medicine    
      St. Louis, Missouri, United States, 63108
United States, New Jersey
Saint Michael's Med Ctr    
      Newark, New Jersey, United States, 07102
United States, New York
Cornell Univ Med Ctr    
      New York, New York, United States, 10021
Cabrini Med Ctr    
      New York, New York, United States, 10003
SUNY / Health Sciences Ctr at Stony Brook    
      Stony Brook, New York, United States, 117948153
United States, Ohio
Ohio State Univ Hosp    
      Columbus, Ohio, United States, 43210
United States, Pennsylvania
Buckley Braffman Stern Med Associates    
      Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Univ TX San Antonio Health Science Ctr    
      San Antonio, Texas, United States, 78284
United States, Virginia
Infectious Disease Physicians Inc    
      Annandale, Virginia, United States, 22203

Sponsors and Collaborators
Pfizer
  More Information


Study ID Numbers:   012M, 056-171
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002282
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections  
Fluconazole  
Clotrimazole  
Acquired Immunodeficiency Syndrome  
Candidiasis, Oral  

Study placed in the following topic categories:
Fluconazole
Mouth Diseases
Opportunistic Infections
Candidiasis, Oral
Sexually Transmitted Diseases, Viral
Candidiasis
Clotrimazole
Miconazole
Acquired Immunodeficiency Syndrome
Tioconazole
Immunologic Deficiency Syndromes
Virus Diseases
Mycoses
HIV Infections
AIDS-Related Opportunistic Infections
Sexually Transmitted Diseases
Stomatognathic Diseases
Retroviridae Infections

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Infective Agents, Local
Communicable Diseases
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Antifungal Agents
Therapeutic Uses
Lentivirus Infections
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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