HIV Infections Clinical Trial
Official title:
Randomized, Controlled, Double-Blind Study of Itraconazole Oral Solution Versus Fluconazole Tablets for the Treatment of Esophageal Candidiasis.
NCT number | NCT00002132 |
Other study ID # | 236A |
Secondary ID | ITR-USA-12 |
Status | Completed |
Phase | N/A |
First received | November 2, 1999 |
Last updated | June 23, 2005 |
To evaluate the safety and efficacy of itraconazole oral solution versus fluconazole tablets for the treatment of esophageal candidiasis in immunocompromised patients.
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 13 Years and older |
Eligibility |
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). |
Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Emory Univ School of Medicine | Atlanta | Georgia |
United States | Austin Infectious Disease Consultants | Austin | Texas |
United States | Johns Hopkins Univ School of Medicine | Baltimore | Maryland |
United States | Montefiore Med Ctr | Bronx | New York |
United States | Erie County Med Ctr | Buffalo | New York |
United States | Univ of North Carolina | Chapel Hill | North Carolina |
United States | Rush Presbyterian - Saint Luke's Med Ctr | Chicago | Illinois |
United States | Univ Hosps of Cleveland | Cleveland | Ohio |
United States | Wayne State Univ / Harper Hosp | Detroit | Michigan |
United States | Houston Veterans Administration Med Ctr | Houston | Texas |
United States | Infectious Diseases Association / Research Med Ctr | Kansas City | Missouri |
United States | Univ of Missouri at Kansas City School of Medicine | Kansas City | Missouri |
United States | Los Angeles County - USC Med Ctr | Los Angeles | California |
United States | Dr Douglas Dieterich | New York | New York |
United States | UCSD Med Ctr | San Diego | California |
United States | Dr Eskild A Petersen | Tucson | Arizona |
United States | George Washington Univ Med Ctr | Washington | District of Columbia |
United States | Bowman Gray School of Medicine | Winston Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Janssen Pharmaceuticals |
United States,
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. — View Citation
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