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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

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Candidiasis, Oral; HIV Infections

Intervention: Clotrimazole (Drug); Fluconazole (Drug)

Phase: N/A

Status: Completed

Sponsored by: Pfizer

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.

Clinical Details

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 design: Primary Purpose: Treatment

Eligibility

Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Dr Robert Larsen, Los Angeles, California 90033, United States

Summitt Med Ctr / San Francisco Gen Hosp, Oakland, California 94609, United States

Davies Med Ctr, San Francisco, California 94114, United States

UCSF Hosp, San Francisco, California 941430654, United States

Saint Raphael's Hosp, New Haven, Connecticut 06511, United States

George Washington Univ Med Ctr, Washington, District of Columbia 20037, United States

Johns Hopkins Hosp, Baltimore, Maryland 21205, United States

Univ Hosp, Boston, Massachusetts 02118, United States

Washington Univ School of Medicine, St. Louis, Missouri 63108, United States

Saint Michael's Med Ctr, Newark, New Jersey 07102, United States

Cabrini Med Ctr, New York, New York 10003, United States

Cornell Univ Med Ctr, New York, New York 10021, United States

SUNY / Health Sciences Ctr at Stony Brook, Stony Brook, New York 117948153, United States

Ohio State Univ Hosp, Columbus, Ohio 43210, United States

Buckley Braffman Stern Med Associates, Philadelphia, Pennsylvania 19107, United States

Univ TX San Antonio Health Science Ctr, San Antonio, Texas 78284, United States

Infectious Disease Physicians Inc, Annandale, Virginia 22203, United States

Additional Information


Last updated: June 23, 2005

Page last updated: August 23, 2015

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