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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002133
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

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

Condition or disease Intervention/treatment Phase
Candidiasis, Oral HIV Infections Drug: Itraconazole Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:


  • 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:


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002133

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
Dr Douglas Ward
Washington, District of Columbia, United States, 20009
George Washington Univ Med Ctr
Washington, District of Columbia, United States, 20037
Veterans Administration Med Ctr
Washington, District of Columbia, United States, 20422
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
Ann Arbor Veterans Administration Med Ctr
Ann Arbor, Michigan, United States, 48105
Wayne State Univ / Harper Hosp
Detroit, Michigan, United States, 48201
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

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) Identifier: NCT00002133     History of Changes
Other Study ID Numbers: 236B
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: April 1996

Keywords provided by NIH AIDS Clinical Trials Information Service:
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Candidiasis, Oral

Additional relevant MeSH terms:
HIV Infections
Candidiasis, Oral
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Mouth Diseases
Stomatognathic Diseases
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors