Clinical trial NCT00002132: Randomized, Controlled, Double-Blind Study of Itraconazole Oral Solution Versus Fluconazole Tablets for the Treatment of Esophageal Candidiasis.
Official title: Randomized, Controlled, Double-Blind Study of Itraconazole Oral Solution Versus Fluconazole Tablets for the Treatment of Esophageal Candidiasis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Candidiasis, Esophageal
HIV Infections
Keywords: Itraconazole
Fluconazole
Acquired Immunodeficiency Syndrome
Candidiasis
Immunocompromised Host
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 evaluate the safety and efficacy of itraconazole oral solution versus fluconazole tablets for the treatment of esophageal candidiasis in immunocompromised patients.


Eligibility criteria: Inclusion Criteria

Patients must have:

* Esophageal candidiasis.
* Histological evidence of Candida spp. at baseline with confirmation by positive mycological culture.
* HIV infection or other predisposing risk factor.
* Life expectancy of at least 2 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Malignancies of the head or neck, if the treatment or disease will interfere with response assessment.
* Evidence of systemic fungal infection.
* Underlying clinical condition that would preclude study completion.
* Judged to be unreliable in regard to following physician's directives.

Concurrent Medication:

Excluded:

* Rifampin.
* Rifabutin.
* Phenobarbital.
* Phenytoin.
* Carbamazepine.
* Terfenadine.
* Astemizole.
* H2 blockers.
* Continual antacids.
* Any investigational drug (expanded access drugs are allowed).

Patients with the following prior conditions are excluded:

* History of significant hepatic abnormalities or clinical evidence of hepatic disease within 2 months prior to study entry.
* History of hypersensitivity to imidazole or azole compounds.

Prior Medication:

Excluded:

* Other orally administered antifungal therapy within 3 days prior to study entry.
* Any investigational drug within 1 month prior to study entry (expanded access drugs are allowed).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Dr Eskild A Petersen
state: Arizona
city: Los Angeles
country: United States
facility: Los Angeles County - USC Med Ctr
state: California
city: San Diego
country: United States
facility: UCSD Med Ctr
state: California
city: Washington
country: United States
facility: George Washington Univ Med Ctr
state: District of Columbia
city: Atlanta
country: United States
facility: Emory Univ School of Medicine
state: Georgia
city: Chicago
country: United States
facility: Rush Presbyterian - Saint Luke's Med Ctr
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Univ School of Medicine
state: Maryland
city: Detroit
country: United States
facility: Wayne State Univ / Harper Hosp
state: Michigan
city: Kansas City
country: United States
facility: Univ of Missouri at Kansas City School of Medicine
state: Missouri
city: Kansas City
country: United States
facility: Infectious Diseases Association / Research Med Ctr
state: Missouri
city: Bronx
country: United States
facility: Montefiore Med Ctr
state: New York
city: Buffalo
country: United States
facility: Erie County Med Ctr
state: New York
city: New York
country: United States
facility: Dr Douglas Dieterich
state: New York
city: Chapel Hill
country: United States
facility: Univ of North Carolina
state: North Carolina
city: Winston Salem
country: United States
facility: Bowman Gray School of Medicine
state: North Carolina
city: Cleveland
country: United States
facility: Univ Hosps of Cleveland
state: Ohio
city: Austin
country: United States
facility: Austin Infectious Disease Consultants
state: Texas
city: Houston
country: United States
facility: Houston Veterans Administration Med Ctr
state: Texas
Study officials:
References:
citation: Barbaro G, Barbarini G, Di Lorenzo G. Fluconazole compared with itraconazole in the treatment of esophageal candidiasis in AIDS patients: a double-blind, randomized, controlled clinical study. Scand J Infect Dis. 1995;27(6):613-7. doi: 10.3109/00365549509047076.