An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.

HIV Infections Clinical Trial

Official title:

An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002133
• Other study ID #: 236B
• Secondary ID: ITR-USA-94
• 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 assess the efficacy and safety of itraconazole oral solution in HIV-seropositive patients with oropharyngeal candidiasis that is refractory to fluconazole.

Description:

Patients receive itraconazole oral solution twice daily. Per 08/15/94 amendment, patients with complete resolution of oropharyngeal candidiasis lesions upon completion of treatment are eligible for maintenance treatment on protocol FDA 236C. Patients who decline maintenance are followed for 6 weeks. Patients who relapse during follow-up are re-treated for 14-28 days; if lesions clear, patients may enter the maintenance protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria

Patients must have:

• HIV antibody seropositivity or diagnosis of AIDS.

• Confirmed oropharyngeal candidiasis.

• Failed fluconazole treatment within the past 14 days.

• Life expectancy of at least 3 months.

• NO symptoms of esophageal candidiasis (e.g., dysphagia) unless endoscopic exam of esophagus was performed and fungal esophagitis was not present.

• NO prior disseminated candidiasis.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Underlying clinical condition that precludes study completion or places the patient at significant risk.

• Considered unreliable about following physician's directives.

Concurrent Medication:

Excluded:

• Investigational drugs (approved expanded access drugs are permitted).

• Rifampin.

• Rifabutin.

• Phenobarbital.

• Phenytoin.

• Carbamazepine.

• Terfenadine.

• Astemizole.

Patients with the following prior conditions are excluded:

• History of hypersensitivity to imidazole or azole compounds.

• Clinical evidence of significant hepatic disease within the past 2 months.

Prior Medication:

Excluded:

• Investigational drugs within 1 month prior to study entry (approved expanded access drugs are permitted).

Study Design

Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Oral
• HIV Infections

Intervention

Drug:
• Itraconazole

Locations

Country	Name	City	State
United States	Ann Arbor Veterans Administration Med Ctr	Ann Arbor	Michigan
United States	East Bay AIDS Ctr	Berkeley	California
United States	Natl Inst of Allergy & Infect Dis / Cln Ctr	Bethesda	Maryland
United States	Univ of Alabama at Birmingham	Birmingham	Alabama
United States	Univ of Virginia Health Sciences Ctr	Charlottesville	Virginia
United States	Ohio State Univ Hosp	Columbus	Ohio
United States	Wayne State Univ / Harper Hosp	Detroit	Michigan
United States	Infectious Diseases Research Clinic / Indiana Univ Hosp	Indianapolis	Indiana
United States	Univ of Arkansas for Med Sciences	Little Rock	Arkansas
United States	Infectious Disease Clinic	Nashville	Tennessee
United States	Oklahoma City Veterans Administration Med Ctr	Oklahoma City	Oklahoma
United States	Pennsylvania Hosp	Philadelphia	Pennsylvania
United States	Audie L Murphy Veterans Administration Hosp	San Antonio	Texas
United States	Kaiser Permanente Med Ctr	San Francisco	California
United States	Washington Univ	St. Louis	Missouri
United States	Dr Douglas Ward	Washington	District of Columbia
United States	George Washington Univ Med Ctr	Washington	District of Columbia
United States	Veterans Administration Med Ctr	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Janssen, LP

Country where clinical trial is conducted

United States, 

References & Publications (1)

Moskovitz B, Wu J, Baruch A, Benken C. Long term safety and efficacy of itraconazole oral solution (IS) for treatment of fluconazole refractory oropharyngeal candidiasis (OC) in HIV-positive patients (pts). Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:124 (abstract no 325)