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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 Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on 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 conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. 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 Clinical research trials and 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 healthcare trials occur in a lot of 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 generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including 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. 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 Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a 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 clinical trial. Test subjects typically receive the most effective healthcare possible for their 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 condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.

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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



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

For Condition: Candidiasis, Oral,HIV Infections
Status: Completed
Sponsor(s): Janssen Pharmaceutica ,
Synopsis: To provide maintenance treatment with itraconazole solution for patients who were clinical responders in the ITR-USA-94 protocol, even if they subsequently relapsed.
Details: Patients who responded to therapy on protocol FDA 236B receive maintenance with itraconazole oral solution for up to 6 months.
Eligibility:
Study Type:
  Interventional, Treatment, Open Label, Efficacy Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 

Location and Contact Information:

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


Additional Information:
Study ID Numbers:
  236C;  ITR-USA-107
Study Start Date: 
Record last reviewed: April 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002341

Other Hiv Infections Studies:
1. Safety and Effectiveness of Fluconazole Versus SCH 56592 to Treat Thrush in HIV-Positive Patients

2. The Effect of Oral Candidiasis on the Speech Production, Feeding Skills, and Self-Concept of Children and Adolescents with Symptomatic HIV Infection

3. Oral Manifestations of Human Immunodeficiency Virus Infection in High Risk Groups

4. Safety and Effectiveness of Giving Lamisil to HIV-Positive Subjects With Thrush Who Have Not Responded to Fluconazole Treatment

5. A Study of Amphotericin B in the Treatment of Fungal Infections of the Mouth in HIV-Infected Patients Who Have Not Had Success with Fluconazole

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