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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00002282

Collaborator

(none)

Locations

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Dr Robert Larsen	Los Angeles	California	United States	90033
2	Summitt Med Ctr / San Francisco Gen Hosp	Oakland	California	United States	94609
3	Davies Med Ctr	San Francisco	California	United States	94114
4	UCSF Hosp	San Francisco	California	United States	941430654
5	Saint Raphael's Hosp	New Haven	Connecticut	United States	06511
6	George Washington Univ Med Ctr	Washington	District of Columbia	United States	20037
7	Johns Hopkins Hosp	Baltimore	Maryland	United States	21205
8	Univ Hosp	Boston	Massachusetts	United States	02118
9	Washington Univ School of Medicine	St. Louis	Missouri	United States	63108
10	Saint Michael's Med Ctr	Newark	New Jersey	United States	07102
11	Cabrini Med Ctr	New York	New York	United States	10003
12	Cornell Univ Med Ctr	New York	New York	United States	10021
13	SUNY / Health Sciences Ctr at Stony Brook	Stony Brook	New York	United States	117948153
14	Ohio State Univ Hosp	Columbus	Ohio	United States	43210
15	Buckley Braffman Stern Med Associates	Philadelphia	Pennsylvania	United States	19107
16	Univ TX San Antonio Health Science Ctr	San Antonio	Texas	United States	78284
17	Infectious Disease Physicians Inc	Annandale	Virginia	United States	22203