NCT00002370已完成不适用
Pharmacokinetics Study of Intravenous Itraconazole Followed by Oral Dosing at 200 Mg Twice Daily in Patients With Advanced HIV Infection
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Janssen, LP
- 入组人数
- 36
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
Patients will receive intravenous itraconazole solution twice daily for 2 days and then once daily for five additional days. Patients then randomized to receive twice-daily or once-daily itraconazole oral solution for an additional 28 days.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •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/mm
- •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:
- •Antiretroviral therapy providing patient has been on a stable, unchanged regimen for 8 weeks prior to study entry.
排除标准
- •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:
- •Rifampin.
- •Rifabutin.
- •Phenobarbital.
- •Phenytoin.
- •Carbamazepine.
- •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 within 15 days prior to study entry:
- •Rifampin.
- •Rifabutin.
- •Phenobarbital.
- •Phenytoin.
- •Carbamazepine.
- •Warfarin.
- •Midazolam.
- •Triazolam.
- •Excluded within 8 weeks prior to study entry:
- •Change in antiretroviral therapy.
- •Risk Behavior:
- •Patients who chew tobacco or regularly smoke more than 10 cigarettes per day.
研究者
研究点 (1)
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