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Clinical Trials

MainTitle

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
Sponsor
Janssen, LP


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002341

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: April 1996
History of Changes
Purpose

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 Intervention
Candidiasis, Oral
HIV Infections

Drug : Itraconazole

Study Type: Interventional
Study Design: 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

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

Detailed Description:

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

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 65 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002341

Locations

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

Sponsors and Collaborators

Janssen, LP
More Information

More Information


Responsible Party: Janssen, LP  
ClinicalTrials.gov Identifier: NCT00002341   History of Changes  
Other Study ID Numbers: 236C  
  ITR-USA-107  
Study First Received: November 2, 1999  
Last Updated: June 23, 2005  

Keywords provided by NIH AIDS Clinical Trials Information Service:

Itraconazole
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Candidiasis, Oral

Additional relevant MeSH terms:
Infection
HIV Infections
Candidiasis
Candidiasis, Oral
Itraconazole
Hydroxyitraconazole
Fluconazole

ClinicalTrials.gov processed this data on October 17, 2017
This information is provided by ClinicalTrials.gov.