Randomized, Controlled, Double-Blind Study of Itraconazole Oral Solution Versus Fluconazole Tablets for the Treatment of Esophageal Candidiasis.

Completed · Not applicable

Conditions studied: Candidiasis, Esophageal, HIV Infections

In brief

To evaluate the safety and efficacy of itraconazole oral solution versus fluconazole tablets for the treatment of esophageal candidiasis in immunocompromised patients.

Key facts

Study ID

NCT00002132

Run by

Janssen Pharmaceuticals

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• Johns Hopkins Univ School of Medicine — Baltimore, Maryland, United States
• Wayne State Univ / Harper Hosp — Detroit, Michigan, United States
• Univ of Missouri at Kansas City School of Medicine — Kansas City, Missouri, United States
• Infectious Diseases Association / Research Med Ctr — Kansas City, Missouri, United States
• Erie County Med Ctr — Buffalo, New York, United States
• Dr Douglas Dieterich — New York, New York, United States
• Montefiore Med Ctr — The Bronx, New York, United States
• Univ of North Carolina — Chapel Hill, North Carolina, United States
• Bowman Gray School of Medicine — Winston-Salem, North Carolina, United States
• Univ Hosps of Cleveland — Cleveland, Ohio, United States
• Austin Infectious Disease Consultants — Austin, Texas, United States
• Houston Veterans Administration Med Ctr — Houston, Texas, United States
• Dr Eskild A Petersen — Tucson, Arizona, United States
• Los Angeles County - USC Med Ctr — Los Angeles, California, United States
• UCSD Med Ctr — San Diego, California, United States
• George Washington Univ Med Ctr — Washington D.C., District of Columbia, United States
• Emory Univ School of Medicine — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.