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

This study has been completed.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	Janssen, LP
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002133

Purpose

To assess the efficacy and safety of itraconazole oral solution in HIV-seropositive patients with oropharyngeal candidiasis that is refractory to fluconazole.

Condition	Intervention
Candidiasis, Oral HIV Infections	Drug: Itraconazole

Study Type:	Interventional
Study Design:	Treatment, Open Label, Safety Study
Official Title:	An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.

Resource links provided by NLM:

MedlinePlus related topics: AIDS Yeast Infections

Drug Information available for: Itraconazole Fluconazole

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002133

Locations

United States, Alabama
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arkansas
Univ of Arkansas for Med Sciences
Little Rock, Arkansas, United States, 72205
United States, California
East Bay AIDS Ctr
Berkeley, California, United States, 94705
Kaiser Permanente Med Ctr
San Francisco, California, United States, 94115
United States, District of Columbia
George Washington Univ Med Ctr
Washington, District of Columbia, United States, 20037
Veterans Administration Med Ctr
Washington, District of Columbia, United States, 20422
Dr Douglas Ward
Washington, District of Columbia, United States, 20009
United States, Indiana
Infectious Diseases Research Clinic / Indiana Univ Hosp
Indianapolis, Indiana, United States, 46202
United States, Maryland
Natl Inst of Allergy & Infect Dis / Cln Ctr
Bethesda, Maryland, United States, 20892
United States, Michigan
Wayne State Univ / Harper Hosp
Detroit, Michigan, United States, 48201
Ann Arbor Veterans Administration Med Ctr
Ann Arbor, Michigan, United States, 48105
United States, Missouri
Washington Univ
St. Louis, Missouri, United States, 63108
United States, Ohio
Ohio State Univ Hosp
Columbus, Ohio, United States, 43210
United States, Oklahoma
Oklahoma City Veterans Administration Med Ctr
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Pennsylvania Hosp
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Infectious Disease Clinic
Nashville, Tennessee, United States, 37212
United States, Texas
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, United States, 78284
United States, Virginia
Univ of Virginia Health Sciences Ctr
Charlottesville, Virginia, United States, 22908

Sponsors and Collaborators

Janssen, LP

More Information

Publications:

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)

Study ID Numbers:	236B, ITR-USA-94
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002133 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Itraconazole
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Candidiasis, Oral

Additional relevant MeSH terms:

Mouth Diseases
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Candidiasis, Oral
Antiprotozoal Agents
Slow Virus Diseases
Candidiasis
Infection
Itraconazole
Hydroxyitraconazole
Mycoses
Antiparasitic Agents
Antifungal Agents

Therapeutic Uses
Retroviridae Infections
Fluconazole
RNA Virus Infections
Immune System Diseases
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Stomatognathic Diseases

ClinicalTrials.gov processed this record on November 27, 2009