Randomized, Controlled, Double-Blind Study of Itraconazole Oral Solution Versus Fluconazole Tablets for the Treatment of Esophageal Candidiasis.
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: April 1996
History of Changes
To evaluate the safety and efficacy of itraconazole oral solution versus fluconazole tablets for the treatment of esophageal candidiasis in immunocompromised patients.
Drug : Itraconazole
Drug : Fluconazole
Primary Purpose: Treatment
|Official Title:||Randomized, Controlled, Double-Blind Study of Itraconazole Oral Solution Versus Fluconazole Tablets for the Treatment of Esophageal Candidiasis.|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
|Ages Eligible for Study:||13 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- 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.
- H2 blockers.
- Continual antacids.
- Any investigational drug (expanded access drugs are allowed).
- 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.
- 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
Patients with the following symptoms or conditions are excluded:
Patients with the following prior conditions are excluded:
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002132
Locations Show More
|United States, Arizona|
|Dr Eskild A Petersen|
|Tucson, Arizona, United States, 85724|
|United States, California|
|Los Angeles County - USC Med Ctr|
|Los Angeles, California, United States, 90033|
|UCSD Med Ctr|
|San Diego, California, United States, 92103|
|United States, District of Columbia|
|George Washington Univ Med Ctr|
|Washington, District of Columbia, United States, 20037|
|United States, Georgia|
|Emory Univ School of Medicine|
|Atlanta, Georgia, United States, 30303|
|United States, Illinois|
|Rush Presbyterian - Saint Luke's Med Ctr|
|Chicago, Illinois, United States, 60612|
|United States, Maryland|
|Johns Hopkins Univ School of Medicine|
|Baltimore, Maryland, United States, 21205|
|United States, Michigan|
|Wayne State Univ / Harper Hosp|
|Detroit, Michigan, United States, 48201|
|United States, Missouri|
|Univ of Missouri at Kansas City School of Medicine|
|Kansas City, Missouri, United States, 64108|
|Infectious Diseases Association / Research Med Ctr|
|Kansas City, Missouri, United States, 64132|
|United States, New York|
|Montefiore Med Ctr|
|Bronx, New York, United States, 10467|
|Erie County Med Ctr|
|Buffalo, New York, United States, 14215|
|Dr Douglas Dieterich|
|New York, New York, United States, 10016|
|United States, North Carolina|
|Univ of North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|Bowman Gray School of Medicine|
|Winston Salem, North Carolina, United States, 27157|
|United States, Ohio|
|Univ Hosps of Cleveland|
|Cleveland, Ohio, United States, 44106|
|United States, Texas|
|Austin Infectious Disease Consultants|
|Austin, Texas, United States, 78705|
|Houston Veterans Administration Med Ctr|
|Houston, Texas, United States, 77030|
Sponsors and CollaboratorsJanssen Pharmaceuticals
|Responsible Party:||Janssen Pharmaceuticals|
|ClinicalTrials.gov Identifier:||NCT00002132 History of Changes|
|Other Study ID Numbers:||236A|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Itraconazole
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.