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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

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ClinicalTrials.gov Identifier: NCT00002282
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Candidiasis, Oral HIV Infections Drug: Clotrimazole Drug: Fluconazole Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Primary Purpose: 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

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002282


Locations
United States, California
Dr Robert Larsen
Los Angeles, California, United States, 90033
Summitt Med Ctr / San Francisco Gen Hosp
Oakland, California, United States, 94609
Davies Med Ctr
San Francisco, California, United States, 94114
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
Cabrini Med Ctr
New York, New York, United States, 10003
Cornell Univ Med Ctr
New York, New York, United States, 10021
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
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ClinicalTrials.gov Identifier: NCT00002282     History of Changes
Other Study ID Numbers: 012M
056-171
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: February 1990

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Candidiasis
Candidiasis, Oral
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
 Mycoses
Mouth Diseases
Stomatognathic Diseases
Fluconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors