此页面是自动翻译的，不保证翻译的准确性。请参阅英文版对于源文本。

Study on the Usage, Dosing, Tolerability, and Effectiveness of Kaletra Tablet

2017年5月18日更新者：AbbVie (prior sponsor, Abbott)

Use of KALETRA® Tablets in Adult HIV-infected Patients: Data From the Multicenter Star/Stella Cohort

The objective of this study is to observe and collect data on the usage, dosing, tolerability, and effectiveness of Kaletra (lopinavir/ritonavir) tablets in human immunodeficiency virus (HIV)-infected patients. In some patients, the study is to show the impact on tolerability of changing therapy to Kaletra tablets from other regimens.

研究概览

地位

完全的

条件

人类免疫缺陷病毒

详细说明

This study was designed as a non-interventional observational study. Kaletra was prescribed in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines.

研究类型

观察性的

注册 (实际的)

3049

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年至 99年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Community sample; HIV-infected patients
For Belgium: AIDS references centers (probability sample)

描述

Inclusion Criteria:

Patients with HIV infection
Patients that will be treated with Kaletra tablets independent from their participation in this study

Exclusion Criteria:

Hypersensitivity against Kaletra or other ingredients
Severe liver insufficiency
No concommitant astemizole, terfenadine, oral midazolam, triazolam, cisapride, pimozide, amiodarone, ergotamine, dihydroergotamine, ergometrine, methylergometrine, vardenafil and St. John's wort
Patients who received more than 1 protease inhibitor during their therapy history

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
HIV-infected Participants HIV-infected participants starting with Kaletra tablets. Participants included 3 subgroups: antiretroviral therapy (ART) treatment-naïve participants starting with Kaletra tablets participants receiving their first protease inhibitor (PI)-containing regimen (apart from Kaletra) pretreated with any non nucleoside reverse transcriptase inhibitor (NNRTI)-containing or nucleoside reverse transcriptase inhibitor (NRTI)-containing regimen participants pretreated with a PI-containing regimen (apart from Kaletra).

团体/队列

HIV-infected Participants

HIV-infected participants starting with Kaletra tablets.

Participants included 3 subgroups:

antiretroviral therapy (ART) treatment-naïve participants starting with Kaletra tablets
participants receiving their first protease inhibitor (PI)-containing regimen (apart from Kaletra) pretreated with any non nucleoside reverse transcriptase inhibitor (NNRTI)-containing or nucleoside reverse transcriptase inhibitor (NRTI)-containing regimen
participants pretreated with a PI-containing regimen (apart from Kaletra).

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
绝对分化簇 4 (CD4) 细胞计数相对于基线的变化大体时间：基线（第 0 周）至第 144 周	参与者的 CD4 细胞计数的变化是通过测量作为常规护理一部分的计划就诊时 CD4 细胞数量相对于基线的变化来评估的。	基线（第 0 周）至第 144 周
HIV-1 核糖核酸 (RNA) 病毒载量相对于基线的变化大体时间：基线（第 0 周）至第 144 周	参与者的 HIV-1 RNA 病毒载量的变化是通过在作为常规护理的一部分计划的定期访问中测量与基线相比的变化来评估的。	基线（第 0 周）至第 144 周

其他结果措施

结果测量	措施说明	大体时间
Prevalence of Adverse Events (Weeks 0-144), Per Event 大体时间：Weeks 0 to 144	Percentage of overall number of adverse events experienced during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the electronic case report form (eCRF). The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low high density lipoprotein (HDL) cholesterol, high low density lipoprotein (LDL) cholesterol, hyperglycemia, hyperbilirubinemia, elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT), elevated gamma glutamyl transferase (γGT), elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, neurocontrol disorder, headache, fatigue, fever, other (listed as 'not specified').	Weeks 0 to 144
Prevalence of Adverse Events (Weeks 0-144), Per Participant 大体时间：Weeks 0 to 144	Percentage of participants who experienced at least 1 adverse event during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the eCRF. The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low HDL cholesterol, high LDL cholesterol, hyperglycemia, hyperbilirubinemia, elevated AST, elevated ALT, elevated γGT, elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, neurocontrol disorder, headache, fatigue, fever, other (listed as 'not specified').	Weeks 0 to 144

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

AbbVie (prior sponsor, Abbott)

合作者

Veeda Clinical Research

调查人员

研究主任：Sandra Bloch, MD、AbbVie Deutschland GmbH & Co. KG, Medical Department

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

Related Info

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2006年8月1日

初级完成 (实际的)

2016年1月1日

研究完成 (实际的)

2016年1月1日

研究注册日期

首次提交

2010年2月26日

首先提交符合 QC 标准的

2010年3月31日

首次发布 (估计)

2010年4月2日

研究记录更新

最后更新发布 (实际的)

2017年5月23日

上次提交的符合 QC 标准的更新

2017年5月18日

最后验证

2017年5月1日