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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• 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

Study information

• Verified date: April 1996
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• 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).

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Esophageal
• HIV Infections

Intervention

Drug:
• Itraconazole

• Fluconazole

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

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