Completed
Fluconazole vs Nystatin Oral Suspension for Oropharyngeal Candidiasis in AIDS Patients
What is being tested
Nystatin
+ Fluconazole
Drug
Who is being recruted
Blood-Borne Infections+20
+ Urogenital Diseases
+ Genital Diseases
Over 13 Years
+11 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Summary
Principal SponsorPfizer
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Patients are randomized to receive fluconazole oral suspension once daily (swallowed at approximately the same time every day) for 14 days or nystatin oral suspension used to rinse the mouth four times daily for 14 days. No food or drink is permitted immediately following the administration of the nystatin.
Principal SponsorPfizer
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 13 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesBacterial Infections and MycosesCandidiasisCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsStomatognathic DiseasesMouth DiseasesMycosesRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexCandidiasis, OralHIV Infections
Criteria
5 inclusion criteria required to participate
Allowed concurrent medications: Phenytoin, Oral hypoglycemics, Coumarin-type anticoagulants, Cyclosporine
Patients must have ARC or AIDS
Patients must have a life expectancy of at least 4 weeks
Patients must have confirmation of diagnosis by microscopic exam and culture of organism
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6 exclusion criteria prevent from participating
Excluded concurrent medications: Antifungal agents other than study drugs, Other experimental medications
Patients who are unable to tolerate oral medication
Patients who have taken other antifungal agents within the past 3 days
Patients with a known history of intolerance or allergy to imidazoles or triazoles or the polyene components of nystatin
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Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 5 locations
UCSF Hosp
San Francisco, United StatesJohns Hopkins School of Medicine
Baltimore, United StatesMed College of Pennsylvania
Philadelphia, United StatesCompleted5 Study Centers