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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 is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about 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 committed 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 health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts 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 permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes 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. Human subjects often get the best 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, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.

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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

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