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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002282
Enrollment
Unknown
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Candidiasis, Oral, HIV Infections

Keywords

AIDS-Related Opportunistic Infections, Fluconazole, Clotrimazole, Acquired Immunodeficiency Syndrome, Candidiasis, Oral

Brief 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.

Interventions

DRUGClotrimazole
DRUGFluconazole

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
13 Years to No maximum
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026