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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	13 Years and older (Child, Adult, Senior)
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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00002282 History of Changes
Other Study ID Numbers:	012M; 056-171
First Posted:	August 31, 2001
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