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

Primary Purpose

Candidiasis, Oral, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Itraconazole
Sponsored by
Janssen, LP
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Candidiasis, Oral focused on measuring Itraconazole, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Candidiasis, Oral

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Univ of Alabama at Birmingham
  • Univ of Arkansas for Med Sciences
  • East Bay AIDS Ctr
  • Kaiser Permanente Med Ctr
  • Dr Douglas Ward
  • George Washington Univ Med Ctr
  • Veterans Administration Med Ctr
  • Infectious Diseases Research Clinic / Indiana Univ Hosp
  • Natl Inst of Allergy & Infect Dis / Cln Ctr
  • Ann Arbor Veterans Administration Med Ctr
  • Wayne State Univ / Harper Hosp
  • Washington Univ
  • Ohio State Univ Hosp
  • Oklahoma City Veterans Administration Med Ctr
  • Pennsylvania Hosp
  • Infectious Disease Clinic
  • Audie L Murphy Veterans Administration Hosp
  • Univ of Virginia Health Sciences Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Janssen, LP
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1. Study Identification

Unique Protocol Identification Number
NCT00002133
Brief Title
An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.
Official Title
An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.
Study Type
Interventional

2. Study Status

Record Verification Date
April 1996
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Janssen, LP

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis, Oral, HIV Infections
Keywords
Itraconazole, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Candidiasis, Oral

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Itraconazole

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Excluded: 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: Excluded: Investigational drugs within 1 month prior to study entry (approved expanded access drugs are permitted).
Facility Information:
Facility Name
Univ of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Univ of Arkansas for Med Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
East Bay AIDS Ctr
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Kaiser Permanente Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Dr Douglas Ward
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20009
Country
United States
Facility Name
George Washington Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Veterans Administration Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
Infectious Diseases Research Clinic / Indiana Univ Hosp
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Natl Inst of Allergy & Infect Dis / Cln Ctr
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
Ann Arbor Veterans Administration Med Ctr
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Wayne State Univ / Harper Hosp
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Washington Univ
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Ohio State Univ Hosp
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oklahoma City Veterans Administration Med Ctr
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Pennsylvania Hosp
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Infectious Disease Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Audie L Murphy Veterans Administration Hosp
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284
Country
United States
Facility Name
Univ of Virginia Health Sciences Ctr
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
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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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