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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002341
• Other study ID #: 236C
• Secondary ID: ITR-USA-107
• 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 provide maintenance treatment with itraconazole solution for patients who were clinical responders in the ITR-USA-94 protocol, even if they subsequently relapsed.

Description:

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

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:

• 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:

Excluded:

• 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:

Excluded:

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

Study Design

Endpoint Classification: Efficacy 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	Buckley Braffman Stern Med Associates	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Janssen, LP

Country where clinical trial is conducted

United States, 

References & Publications (2)

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)

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)