A Study of Treatments for Fungal Infections of the Mouth and Throat in HIV-Infected Patients Who Have Had Success With Itraconazole But Not With Fluconazole

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: NCT00002341
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 provide maintenance treatment with itraconazole solution for patients who were clinical responders in the ITR-USA-94 protocol, even if they subsequently relapsed.

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

Detailed Description:
Patients who responded to therapy on protocol FDA 236B receive maintenance with itraconazole oral solution for up to 6 months.

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Extension Study of Maintenance Therapy in HIV-Positive Subjects With Fluconazole-Refractory Oropharyngeal Candidiasis Who Have Responded to Itraconazole Oral Solution

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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:

  • Met criteria for clinical response on protocol FDA 236B with no residual visible lesion of oropharyngeal candidiasis upon completion of that study OR had initial response on protocol FDA 236B with subsequent relapse and retreatment with itraconazole solution or other therapies.
  • Life expectancy of at least 3 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Underlying clinical condition that would preclude completion of study or place subject at significant risk.
  • Judged unreliable with respect to physician's directives.

Concurrent Medication:


  • Rifampin.
  • Rifabutin.
  • Phenobarbital.
  • Phenytoin.
  • Carbamazepine.
  • Terfenadine.
  • Astemizole.
  • Systemic antifungals.

Patients with the following prior conditions are excluded:

  • Previously documented disseminated candidiasis.
  • Previous clinically significant adverse event during treatment with itraconazole oral solution, unless clearly attributable to an intercurrent illness or condition.
  • History of significant hepatic abnormalities or clinical evidence of significant hepatic disease within 2 months prior to study entry.

Prior Medication:


  • Any investigational drug (other than itraconazole solution) within 1 month prior to study entry.

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): NCT00002341

United States, Pennsylvania
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, United States, 19107
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)
Fessel WJ, Merrill KW, Ward D, Moskovitz B, Benken C, Oleka N, Grimwood H. Itraconazole oral solution (IS) for the treatment of fluconazole-refractory oropharyngeal candidiasis (OC) in HIV-positive patients. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:124 (abstract no 327) Identifier: NCT00002341     History of Changes
Other Study ID Numbers: 236C
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