NCT00002201已完成不适用
Safety and Efficacy of Ritonavir (ABT-538) in Combination With Nelfinavir in HIV-Infected Subjects.
Abbott1 个研究点 分布在 1 个国家开始时间: 2001年8月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to see if it is safe and effective to give ritonavir plus nelfinavir to HIV-infected patients. This study will also see how ritonavir and nelfinavir are absorbed by the body and how they affect the level of HIV in the blood.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have:
- •Documentation of a positive ELISA test for HIV confirmed by immunoblot, or a positive HIV RNA test using the Roche PCR assay, or the Chiron bDNA assay.
- •HIV RNA measurement of > 5,000 copies/ml within 3 weeks of baseline visit.
- •Signed, informed consent from parent or legal guardian for patients less than 18 years of age.
- •Access to a refrigerator for storing study drug.
- •Prior Medication:
- •Anti-HIV therapy other than protease inhibitor therapy.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Evidence of acute infection, as measured by vital signs, physical examination, 12-lead electrocardiogram and laboratory assessments.
- •Condition that may obscure the proper observation of the safety or activity of the treatment regimens.
- •Concurrent Medication:
- •Midazolam, alprazolam, clorazepate, diazepam, estazolam, flurazepam, triazolam, zolpidem, quinidine, amiodarone, encainide, flecainide, propafenone, bepridil, terfenadine, astemizole, cisapride, bupropion, clozapine, rifabutin, meperidine, propoxyphene, piroxicam, pimozide, ergotamine, dihydroergotamine, and rifampin.
- •Anti-retroviral therapy initiated prior to study entry.
- •Any other medication, including over-the-counter medicine and alcohol, taken without the permission of the primary investigator.
- •Patients with the following prior conditions are excluded:
- •History of significant drug hypersensitivity.
- •History of psychiatric illness that would preclude compliance with the protocol.
- •Prior enrollment in this study.
- •Prior Medication:
- •Investigational drugs within 30 days prior to drug administration.
- •Prior treatment with licensed or investigational HIV protease inhibitor.
- •1. Active substance abuse.
- •Positive urine screen for recreational drugs. NOTE:
- •The presence of cannabis is not exclusionary unless the investigator believes its use will interfere with patient compliance.
研究者
研究点 (1)
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