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.

Sponsor:

Information provided by:

NIH AIDS Clinical Trials Information Service

ClinicalTrials.gov Identifier:

NCT00002282

First received: November 2, 1999

Last updated: June 23, 2005

Last verified: February 1990

History of Changes

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00002282 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	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
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Primary Purpose: Treatment
Condition ^ICMJE	Candidiasis, Oral HIV Infections
Intervention ^ICMJE	Drug: Clotrimazole Drug: Fluconazole
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	13 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00002282
Other Study ID Numbers ^ICMJE	012M, 056-171
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Pfizer
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	February 1990
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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