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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 - Article


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Strep Throat

 




Clinical Trial: 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

This study has been completed.

Sponsored by: Janssen Pharmaceutica
Information provided by: AIDS Clinical Trials Information Service

Purpose

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 Treatment or Intervention
Candidiasis, Oral
HIV Infections
 Drug: Itraconazole

MedlinePlus related topics:  AIDS;   Candidiasis

Study Type: Interventional
Study Design: Treatment, Open Label, Efficacy Study

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

Further Study Details: 

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

Eligibility

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Patients must have:

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.

Location Information


Pennsylvania
      Buckley Braffman Stern Med Associates, Philadelphia,  Pennsylvania,  19107,  United States

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)

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)

Study ID Numbers:  236C; ITR-USA-107
Record last reviewed:  April 1996
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002341
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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November 28, 2009



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