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Sponsored by: |
Janssen, LP |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002370 |
To demonstrate a dosage regimen for intravenous itraconazole that produces a plasma concentration range comparable to that obtained after currently used oral dosages of itraconazole oral solution; and to obtain preliminary safety data in patients with advanced HIV disease.
Condition | Intervention |
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HIV Infections |
Drug: Itraconazole |
Study Type: | Interventional |
Study Design: | Treatment, Dose Comparison, Pharmacokinetics Study |
Official Title: | Pharmacokinetics Study of Intravenous Itraconazole Followed by Oral Dosing at 200 Mg Twice Daily in Patients With Advanced HIV Infection |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Antiretroviral therapy providing patient has already been on a stable, unchanged regimen for 8 weeks prior to study entry.
Patients must have:
Prior Medication:
Allowed:
Antiretroviral therapy providing patient has been on a stable, unchanged regimen for 8 weeks prior to study entry.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior symptoms and conditions are excluded:
Prior Medication:
Excluded:
Excluded within 15 days prior to study entry:
Excluded within 8 weeks prior to study entry:
Risk Behavior:
Excluded:
Patients who chew tobacco or regularly smoke more than 10 cigarettes per day.
Study ID Numbers: | 254B |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002370 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Itraconazole Administration, Oral Antifungal Agents Acquired Immunodeficiency Syndrome Drug Administration Schedule |
Sexually Transmitted Diseases, Viral Clotrimazole Miconazole Acquired Immunodeficiency Syndrome Tioconazole Itraconazole Hydroxyitraconazole |
Immunologic Deficiency Syndromes Virus Diseases HIV Infections Antifungal Agents Sexually Transmitted Diseases Retroviridae Infections |
Anti-Infective Agents Communicable Diseases Antiprotozoal Agents RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Hydroxyitraconazole Itraconazole Infection |
Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases Antiparasitic Agents HIV Infections Therapeutic Uses Antifungal Agents Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |