Clinical trial NCT00002282: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Candidiasis, Oral
HIV Infections
Keywords: AIDS-Related Opportunistic Infections
Fluconazole
Clotrimazole
Acquired Immunodeficiency Syndrome
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
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Dr Robert Larsen
state: California
city: Oakland
country: United States
facility: Summitt Med Ctr / San Francisco Gen Hosp
state: California
city: San Francisco
country: United States
facility: Davies Med Ctr
state: California
city: San Francisco
country: United States
facility: UCSF Hosp
state: California
city: New Haven
country: United States
facility: Saint Raphael's Hosp
state: Connecticut
city: Washington
country: United States
facility: George Washington Univ Med Ctr
state: District of Columbia
city: Baltimore
country: United States
facility: Johns Hopkins Hosp
state: Maryland
city: Boston
country: United States
facility: Univ Hosp
state: Massachusetts
city: St. Louis
country: United States
facility: Washington Univ School of Medicine
state: Missouri
city: Newark
country: United States
facility: Saint Michael's Med Ctr
state: New Jersey
city: New York
country: United States
facility: Cabrini Med Ctr
state: New York
city: New York
country: United States
facility: Cornell Univ Med Ctr
state: New York
city: Stony Brook
country: United States
facility: SUNY / Health Sciences Ctr at Stony Brook
state: New York
city: Columbus
country: United States
facility: Ohio State Univ Hosp
state: Ohio
city: Philadelphia
country: United States
facility: Buckley Braffman Stern Med Associates
state: Pennsylvania
city: San Antonio
country: United States
facility: Univ TX San Antonio Health Science Ctr
state: Texas
city: Annandale
country: United States
facility: Infectious Disease Physicians Inc
state: Virginia
Study officials:
References: