Clinical trial NCT00002112: Comparative Randomized Study of the Efficacy, Safety, and Toleration of Fluconazole Oral Suspension or Nystatin Oral Suspension in the Treatment of Patients With Oropharyngeal Candidiasis in Association With the Acquired Immunodeficiency Syndrome
Official title: Comparative Randomized Study of the Efficacy, Safety, and Toleration of Fluconazole Oral Suspension or Nystatin Oral Suspension in the Treatment of Patients With Oropharyngeal Candidiasis in Association With the Acquired Immunodeficiency Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Candidiasis, Oral
HIV Infections
Keywords: Nystatin
Fluconazole
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Candidiasis, Oral
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy, safety, and toleration of fluconazole as a single daily oral suspension for 14 days versus nystatin oral suspension 4 times daily for 14 days in the treatment of oropharyngeal candidiasis in patients with AIDS or HIV infection.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Phenytoin.
* Oral hypoglycemics.
* Coumarin-type anticoagulants.
* Cyclosporine.

Patients must have:

* ARC or AIDS.
* Signs of oropharyngeal candidiasis (i.e., typical white plaques) with some associated symptoms.
* Confirmation of diagnosis by microscopic exam and culture of organism.
* Life expectancy of at least 4 weeks.

NOTE:

* Patients with signs or symptoms of esophagitis (e.g., odynophagia) are not eligible unless esophagoscopy is performed and results are negative.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions are excluded:

* Unable to tolerate oral medication.
* Concurrent enrollment on another experimental trial of approved or non-approved drugs or systemic compounds (without approval of Pfizer clinical monitor).

Concurrent Medication:

Excluded:

* Antifungal agents other than study drugs.
* Other experimental medications.

Patients with the following prior conditions are excluded:

Known history of intolerance or allergy to imidazoles or triazoles or the polyene components of nystatin.

Prior Medication:

Excluded:

* Other antifungal agents within the past 3 days.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Fresno
country: United States
facility: California Med Research Group
state: California
city: San Francisco
country: United States
facility: UCSF Hosp
state: California
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
city: Philadelphia
country: United States
facility: Med College of Pennsylvania
state: Pennsylvania
city: Hampton
country: United States
facility: Hampton Roads Med Specialists
state: Virginia
Study officials:
References: