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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. Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects. conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects. Clinical research trials and An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects. medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.. An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects. Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects. clinical trial. Participants frequently get the best healthcare available for their An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects. condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.  An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.
An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.
For Condition: Candidiasis, Oral,HIV Infections
Status: Completed
Sponsor(s): Janssen Pharmaceutica ,
Synopsis: To assess the efficacy and safety of itraconazole oral solution in HIV-seropositive patients with oropharyngeal candidiasis that is refractory to fluconazole.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Safety Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry 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).
Total Enrollment:
Location and Contact Information:
East Bay AIDS Ctr
Berkeley, California, 94705
United States
Univ of Arkansas for Med Sciences
Little Rock, Arkansas, 72205
United States
Ohio State Univ Hosp
Columbus, Ohio, 43210
United States
Dr Douglas Ward
Washington D.C., District of Columbia, 20009
United States
Natl Inst of Allergy & Infect Dis / Cln Ctr
Bethesda, Maryland, 20892
United States
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, 78284
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Univ of Virginia Health Sciences Ctr
Charlottesville, Virginia, 22908
United States
Pennsylvania Hosp
Philadelphia, Pennsylvania, 19107
United States
Infectious Diseases Research Clinic / Indiana Univ Hosp
Indianapolis, Indiana, 46202
United States
Ann Arbor Veterans Administration Med Ctr
Ann Arbor, Michigan, 48105
United States
Wayne State Univ / Harper Hosp
Detroit, Michigan, 48201
United States
Oklahoma City Veterans Administration Med Ctr
Oklahoma City, Oklahoma, 73104
United States
Infectious Disease Clinic
Nashville, Tennessee, 37212
United States
Veterans Administration Med Ctr
Washington D.C., District of Columbia, 20422
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Washington Univ
St. Louis, Missouri, 63108
United States
Additional Information:
Study ID Numbers: 236B; ITR-USA-94
Study Start Date:
Record last reviewed: April 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002133
Other Hiv Infections Studies:
1. Comparative Randomized Study of the Efficacy, Safety, and Toleration of Fluconazole Oral Suspension or Nystatin Oral Suspension in the Treatment of Patients With Oropharyngeal Candidiasis in Association With the Acquired Immunodeficiency Syndrome
2. Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC
3. The Effect of Oral Candidiasis on the Speech Production, Feeding Skills, and Self-Concept of Children and Adolescents with Symptomatic HIV Infection
4. Safety and Effectiveness of Fluconazole Versus SCH 56592 to Treat Thrush in HIV-Positive Patients
5. A Study of Nystatin in the Prevention of Fungal Infections of the Mouth in Patients with AIDS or AIDS-Related Syndromes
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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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