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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 February 22, 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.
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Concurrent Medication:

Allowed:

- Cimetidine.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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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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[email protected]

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FOR MORE INFORMATION

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

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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