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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

Primary Purpose

Candidiasis, Oral, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clotrimazole
Fluconazole
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Candidiasis, Oral focused on measuring AIDS-Related Opportunistic Infections, Fluconazole, Clotrimazole, Acquired Immunodeficiency Syndrome, Candidiasis, Oral

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Dr Robert Larsen
  • Summitt Med Ctr / San Francisco Gen Hosp
  • Davies Med Ctr
  • UCSF Hosp
  • Saint Raphael's Hosp
  • George Washington Univ Med Ctr
  • Johns Hopkins Hosp
  • Univ Hosp
  • Washington Univ School of Medicine
  • Saint Michael's Med Ctr
  • Cabrini Med Ctr
  • Cornell Univ Med Ctr
  • SUNY / Health Sciences Ctr at Stony Brook
  • Ohio State Univ Hosp
  • Buckley Braffman Stern Med Associates
  • Univ TX San Antonio Health Science Ctr
  • Infectious Disease Physicians Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00002282
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 1990
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis, Oral, HIV Infections
Keywords
AIDS-Related Opportunistic Infections, Fluconazole, Clotrimazole, Acquired Immunodeficiency Syndrome, Candidiasis, Oral

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Clotrimazole
Intervention Type
Drug
Intervention Name(s)
Fluconazole

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Dr Robert Larsen
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Summitt Med Ctr / San Francisco Gen Hosp
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Davies Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
UCSF Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
941430654
Country
United States
Facility Name
Saint Raphael's Hosp
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
George Washington Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Johns Hopkins Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Univ Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Washington Univ School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Saint Michael's Med Ctr
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
Cabrini Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Cornell Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
SUNY / Health Sciences Ctr at Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
117948153
Country
United States
Facility Name
Ohio State Univ Hosp
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Buckley Braffman Stern Med Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Univ TX San Antonio Health Science Ctr
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284
Country
United States
Facility Name
Infectious Disease Physicians Inc
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22203
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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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