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
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00002282 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Candidiasis, Oral HIV Infections | Drug: Clotrimazole Drug: Fluconazole | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Primary Purpose: | Treatment |
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 |

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 13 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002282
United States, California | |
Dr Robert Larsen | |
Los Angeles, California, United States, 90033 | |
Summitt Med Ctr / San Francisco Gen Hosp | |
Oakland, California, United States, 94609 | |
Davies Med Ctr | |
San Francisco, California, United States, 94114 | |
UCSF Hosp | |
San Francisco, California, United States, 941430654 | |
United States, Connecticut | |
Saint Raphael's Hosp | |
New Haven, Connecticut, United States, 06511 | |
United States, District of Columbia | |
George Washington Univ Med Ctr | |
Washington, District of Columbia, United States, 20037 | |
United States, Maryland | |
Johns Hopkins Hosp | |
Baltimore, Maryland, United States, 21205 | |
United States, Massachusetts | |
Univ Hosp | |
Boston, Massachusetts, United States, 02118 | |
United States, Missouri | |
Washington Univ School of Medicine | |
St. Louis, Missouri, United States, 63108 | |
United States, New Jersey | |
Saint Michael's Med Ctr | |
Newark, New Jersey, United States, 07102 | |
United States, New York | |
Cabrini Med Ctr | |
New York, New York, United States, 10003 | |
Cornell Univ Med Ctr | |
New York, New York, United States, 10021 | |
SUNY / Health Sciences Ctr at Stony Brook | |
Stony Brook, New York, United States, 117948153 | |
United States, Ohio | |
Ohio State Univ Hosp | |
Columbus, Ohio, United States, 43210 | |
United States, Pennsylvania | |
Buckley Braffman Stern Med Associates | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, Texas | |
Univ TX San Antonio Health Science Ctr | |
San Antonio, Texas, United States, 78284 | |
United States, Virginia | |
Infectious Disease Physicians Inc | |
Annandale, Virginia, United States, 22203 |
ClinicalTrials.gov Identifier: | NCT00002282 History of Changes |
Other Study ID Numbers: |
012M 056-171 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | February 1990 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections Fluconazole Clotrimazole Acquired Immunodeficiency Syndrome Candidiasis, Oral |
Additional relevant MeSH terms:
Infection Communicable Diseases HIV Infections Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome Candidiasis Candidiasis, Oral Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immune System Diseases Slow Virus Diseases |
Mycoses Mouth Diseases Stomatognathic Diseases Fluconazole Antifungal Agents Anti-Infective Agents 14-alpha Demethylase Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Steroid Synthesis Inhibitors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Cytochrome P-450 CYP2C9 Inhibitors |