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Comparative Randomized Study of the Efficacy, Safety, and Toleration of Fluconazole Oral Suspension or Nystatin Oral Suspension in the Treatment of Patients With Oropharyngeal Candidiasis in Association With the Acquired Immunodeficiency Syndrome

Primary Purpose

Candidiasis, Oral, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nystatin
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 Nystatin, Fluconazole, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Candidiasis, Oral

Eligibility Criteria

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

Inclusion Criteria Concurrent Medication: Allowed: Phenytoin. Oral hypoglycemics. Coumarin-type anticoagulants. Cyclosporine. Patients must have: ARC or AIDS. Signs of oropharyngeal candidiasis (i.e., typical white plaques) with some associated symptoms. Confirmation of diagnosis by microscopic exam and culture of organism. Life expectancy of at least 4 weeks. NOTE: Patients with signs or symptoms of esophagitis (e.g., odynophagia) are not eligible unless esophagoscopy is performed and results are negative. Exclusion Criteria Co-existing Condition: Patients with the following conditions are excluded: Unable to tolerate oral medication. Concurrent enrollment on another experimental trial of approved or non-approved drugs or systemic compounds (without approval of Pfizer clinical monitor). Concurrent Medication: Excluded: Antifungal agents other than study drugs. Other experimental medications. Patients with the following prior conditions are excluded: Known history of intolerance or allergy to imidazoles or triazoles or the polyene components of nystatin. Prior Medication: Excluded: Other antifungal agents within the past 3 days.

Sites / Locations

  • California Med Research Group
  • UCSF Hosp
  • Johns Hopkins School of Medicine
  • Med College of Pennsylvania
  • Hampton Roads Med Specialists

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
NCT00002112
Brief Title
Comparative Randomized Study of the Efficacy, Safety, and Toleration of Fluconazole Oral Suspension or Nystatin Oral Suspension in the Treatment of Patients With Oropharyngeal Candidiasis in Association With the Acquired Immunodeficiency Syndrome
Official Title
Comparative Randomized Study of the Efficacy, Safety, and Toleration of Fluconazole Oral Suspension or Nystatin Oral Suspension in the Treatment of Patients With Oropharyngeal Candidiasis in Association With the Acquired Immunodeficiency Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 1996
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 toleration of fluconazole as a single daily oral suspension for 14 days versus nystatin oral suspension 4 times daily for 14 days in the treatment of oropharyngeal candidiasis in patients with AIDS or HIV infection.
Detailed Description
Patients are randomized to receive fluconazole oral suspension once daily (swallowed at approximately the same time every day) for 14 days or nystatin oral suspension used to rinse the mouth four times daily for 14 days. No food or drink is permitted immediately following the administration of the nystatin.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Nystatin
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: Phenytoin. Oral hypoglycemics. Coumarin-type anticoagulants. Cyclosporine. Patients must have: ARC or AIDS. Signs of oropharyngeal candidiasis (i.e., typical white plaques) with some associated symptoms. Confirmation of diagnosis by microscopic exam and culture of organism. Life expectancy of at least 4 weeks. NOTE: Patients with signs or symptoms of esophagitis (e.g., odynophagia) are not eligible unless esophagoscopy is performed and results are negative. Exclusion Criteria Co-existing Condition: Patients with the following conditions are excluded: Unable to tolerate oral medication. Concurrent enrollment on another experimental trial of approved or non-approved drugs or systemic compounds (without approval of Pfizer clinical monitor). Concurrent Medication: Excluded: Antifungal agents other than study drugs. Other experimental medications. Patients with the following prior conditions are excluded: Known history of intolerance or allergy to imidazoles or triazoles or the polyene components of nystatin. Prior Medication: Excluded: Other antifungal agents within the past 3 days.
Facility Information:
Facility Name
California Med Research Group
City
Fresno
State/Province
California
ZIP/Postal Code
93726
Country
United States
Facility Name
UCSF Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Johns Hopkins School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Med College of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19129
Country
United States
Facility Name
Hampton Roads Med Specialists
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Comparative Randomized Study of the Efficacy, Safety, and Toleration of Fluconazole Oral Suspension or Nystatin Oral Suspension in the Treatment of Patients With Oropharyngeal Candidiasis in Association With the Acquired Immunodeficiency Syndrome

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