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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

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
Dr Robert Larsen
Los Angeles, California, 90033 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:

- Cimetidine.

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 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

- 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.

NCT00002282
Pfizer
Completed
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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Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
Brief SummaryTo 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE
  • Candidiasis, Oral
  • HIV Infections
Intervention  ICMJE
  • Drug: Clotrimazole
  • 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:

  • 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.
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 NCT00002282
Other Study ID Numbers  ICMJE 012M
056-171
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 DateFebruary 1990

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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