NCT00002223已完成不适用
Ritonavir (ABT-538)/Indinavir Combination Treatment in HIV-Infected Patients Previously Receiving Indinavir 800 mg TID
Abbott6 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
- 6
研究概览
简要总结
The purpose of this study is to determine how many HIV-infected patients continue taking ritonavir/indinavir combination after having taken indinavir three times a day as part of their anti-HIV drug therapy. This study also examines the safety and effectiveness of the ritonavir/indinavir combination.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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:
- •HIV infection.
- •CD4 cell count greater than 100 cells/microliter.
- •HIV RNA levels greater than 400 copies/microliter using the Roche Ultrasensitive assay.
- •No acute illness.
- •Consent of parent or guardian if less than legal age.
- •No prior enrollment in this study.
- •All entry criteria for this study met within 15 days prior to enrollment.
排除标准
- •Co-existing Condition:
- •Patients with any of the following symptoms or conditions are excluded:
- •Any condition that in the opinion of the investigator may obscure proper observation of the safety or activity of the treatment regimens used in this study.
- •Concurrent Medication:
- •Concurrent non-nucleoside reverse transcriptase inhibitors as part of the antiretroviral regimen.
- •Any of the following medications with ritonavir:
- •midazolam, clorazepate, diazepam, estazolam, flurazepam, triazolam, zolpidem, quinidine, amiodarone, encainide, flecainide, propafenone, bepridil, terfenadine, astemizole, cisapride, bupropion, clozapine, rifabutin, meperidine, propoxyphene, piroxicam, pimozide, dihydroergotamine, and ergotamine.
- •Any of the following medications with indinavir:
- •terfenadine, astemizole, cisapride, triazolam, midazolam. No requirement for rifampin or ketoconazole.
- •Any concurrent treatment with other protease inhibitors.
- •Other concurrent medication (including over-the-counter medicine or alcohol) without the knowledge and permission of the primary investigator.
- •Patients with the following prior conditions are excluded:
- •History of significant drug hypersensitivity.
- •Psychiatric illness that precludes compliance with the protocol.
- •Receipt of investigational drug within 30 days prior to administration of study drug.
- •History of acute or chronic pancreatitis.
- •Anticipation of poor patient compliance with protocol.
- •Prior Medication:
- •Prior treatment with ritonavir.
- •Risk Behavior:
- •History of active substance abuse (i.e., recreational drugs or alcohol).
- •- Indinavir 800 mg three times a day plus unspecified nucleosides for at least 3 months.
研究者
研究点 (6)
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