Study of Itraconazole in Patients With Advanced HIV Infection
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Purpose
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 |
|---|---|
|
HIV Infections |
Drug: Itraconazole |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Primary Purpose: Treatment |
| Official Title: | Pharmacokinetics Study of Intravenous Itraconazole Followed by Oral Dosing at 200 Mg Twice Daily in Patients With Advanced HIV Infection |
Eligibility| 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:
- Documented HIV infection.
- CD4 lymphocyte count < 300 cells/mm3.
- No clinically significant abnormalities, elicited by history and physical examination.
- No clinically significant abnormalities in blood count, biochemical profile, or urinalysis within 2 weeks of study entry.
- Negative urine screening.
- No clinically significant abnormalities of electrocardiogram.
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:
- Acute opportunistic infection or other significant concurrent illness that would preclude participation for the required 36 days.
- Unable to swallow oral solution.
- Obesity greater than 25% of ideal body weight.
Concurrent Medication:
Excluded:
- Rifampin.
- Rifabutin.
- Phenobarbital.
- Phenytoin.
- Carbamazepine.
- Digoxin.
- Warfarin.
- Midazolam.
- Triazolam.
- Terfenadine.
- Astemizole.
- Cisapride.
- H2 blockers.
- Omeprazole.
- Continual antacids.
- Didanosine.
- Any medication known to affect absorption, metabolism or excretion of imidazole or azole compounds.
Patients with the following prior symptoms and conditions are excluded:
- Previous hypersensitivity to azole antifungals.
- History of surgical procedure that may interfere with absorption of itraconazole.
- History of significant blood loss in the previous 30 days.
Prior Medication:
Excluded:
Excluded within 15 days prior to study entry:
- Rifampin.
- Rifabutin.
- Phenobarbital.
- Phenytoin.
- Carbamazepine.
- Digoxin.
- Warfarin.
- Midazolam.
- Triazolam.
Excluded within 8 weeks prior to study entry:
- Change in antiretroviral therapy.
Risk Behavior:
Excluded:
Patients who chew tobacco or regularly smoke more than 10 cigarettes per day.
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002370 History of Changes |
| Other Study ID Numbers: | 254B |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
Itraconazole Administration, Oral Antifungal Agents Acquired Immunodeficiency Syndrome Drug Administration Schedule |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome 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 Itraconazole Hydroxyitraconazole 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antifungal Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013