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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002282
• Other study ID #: 012M
• Secondary ID: 056-171
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: February 1990
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Candidiasis
• Candidiasis, Oral
• HIV Infections
• Immunologic Deficiency Syndromes
• Infection

Intervention

Drug:
• Clotrimazole

• Fluconazole

Locations

Country	Name	City	State
United States	Infectious Disease Physicians Inc	Annandale	Virginia
United States	Johns Hopkins Hosp	Baltimore	Maryland
United States	Univ Hosp	Boston	Massachusetts
United States	Ohio State Univ Hosp	Columbus	Ohio
United States	Dr Robert Larsen	Los Angeles	California
United States	Saint Raphael's Hosp	New Haven	Connecticut
United States	Cabrini Med Ctr	New York	New York
United States	Cornell Univ Med Ctr	New York	New York
United States	Saint Michael's Med Ctr	Newark	New Jersey
United States	Summitt Med Ctr / San Francisco Gen Hosp	Oakland	California
United States	Buckley Braffman Stern Med Associates	Philadelphia	Pennsylvania
United States	Univ TX San Antonio Health Science Ctr	San Antonio	Texas
United States	Davies Med Ctr	San Francisco	California
United States	UCSF Hosp	San Francisco	California
United States	Washington Univ School of Medicine	St. Louis	Missouri
United States	SUNY / Health Sciences Ctr at Stony Brook	Stony Brook	New York
United States	George Washington Univ Med Ctr	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States,