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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

Last updated on November 7, 2019

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Study Location
California Med Research Group
Fresno, California, 93726 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Oral Candidiasis, HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT00002112
Pfizer
Completed
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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Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
Brief SummaryTo 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 DescriptionPatients 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Condition  ICMJE
  • Candidiasis, Oral
  • HIV Infections
Intervention  ICMJE
  • Drug: Nystatin
  • Drug: Fluconazole
Study Arms  ICMJE 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
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00002112
Other Study ID Numbers  ICMJE 012Q
R-0223
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS AccountNIH AIDS Clinical Trials Information Service
Verification DateApril 1996

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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