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| Sponsor: | Janssen, LP |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002341 |
Purpose
To provide maintenance treatment with itraconazole solution for patients who were clinical responders in the ITR-USA-94 protocol, even if they subsequently relapsed.
| Condition | Intervention |
|---|---|
|
Candidiasis, Oral HIV Infections |
Drug: Itraconazole |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Masking: 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 |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00002341 History of Changes |
| Other Study ID Numbers: | 236C, ITR-USA-107 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
Itraconazole Acquired Immunodeficiency Syndrome AIDS-Related Complex Candidiasis, Oral |
|
HIV Infections Acquired Immunodeficiency Syndrome Candidiasis Candidiasis, Oral Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Mycoses Mouth Diseases Stomatognathic Diseases Fluconazole Itraconazole Hydroxyitraconazole Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |