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
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: April 1996
History of Changes
To provide maintenance treatment with itraconazole solution for patients who were clinical responders in the ITR-USA-94 protocol, even if they subsequently relapsed.
Drug : Itraconazole
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:
Patients who responded to therapy on protocol FDA 236B receive maintenance with itraconazole oral solution for up to 6 months.Eligibility
|Ages Eligible for Study:||18 Years to 65 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- Underlying clinical condition that would preclude completion of study or place subject at significant risk.
- Judged unreliable with respect to physician's directives.
- Systemic antifungals.
- 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.
- Any investigational drug (other than itraconazole solution) within 1 month prior to
Patients with the following symptoms or conditions are excluded:
Patients with the following prior conditions are excluded:
Contacts and LocationsChoosing 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 Show More
|United States, Pennsylvania|
|Buckley Braffman Stern Med Associates|
|Philadelphia, Pennsylvania, United States, 19107|
Sponsors and CollaboratorsJanssen, LP
|Responsible Party:||Janssen, LP|
|ClinicalTrials.gov Identifier:||NCT00002341 History of Changes|
|Other Study ID Numbers:||236C|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Itraconazole
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on October 17, 2017
This information is provided by ClinicalTrials.gov.