Kaletra: Therapy With Double Protease Inhibitors
2013年1月14日 更新者：AbbVie (prior sponsor, Abbott)
PMOS: Kaletra Double Protease Inhibitors
Therapy with lopinavir/ritonavir (Kaletra) and one other protease inhibitor in Human Immunodeficiency Virus participants
研究概览
地位
完全的
条件
详细说明
This study is intended to observe and collect data on the usage, dosing, tolerability, and effectiveness of lopinavir/ritonavir (Kaletra) when used as part of a Nucleoside Reverse Transcriptase Inhibitors-free double protease regimen.
Enrollment in the study was independent of the decision to prescribe Kaletra.
研究类型
观察性的
注册 (实际的)
65
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Berlin、德国、10439
- Site Reference ID/Investigator# 48283
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Berlin、德国、10551
- Site Reference ID/Investigator# 28131
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Berlin、德国、10961
- Site Reference ID/Investigator# 66422
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Berlin、德国、13347
- Site Reference ID/Investigator# 28123
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Berlin、德国、D-10243
- Site Reference ID/Investigator# 28109
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Dortmund、德国、44137
- Site Reference ID/Investigator# 28115
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Frankfurt、德国、60311
- Site Reference ID/Investigator# 28124
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Frankfurt、德国、60329
- Site Reference ID/Investigator# 28127
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Frankfurt、德国、60596
- Site Reference ID/Investigator# 28119
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Krefeld、德国、47800
- Site Reference ID/Investigator# 5318
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Ludwigshafen、德国、67063
- Site Reference ID/Investigator# 28112
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Muenster、德国、48143
- Site Reference ID/Investigator# 28111
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Muenster、德国、48149
- Site Reference ID/Investigator# 28129
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Munich、德国、80337
- Site Reference ID/Investigator# 28118
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Munich、德国、80801
- Site Reference ID/Investigator# 28113
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Stuttgart、德国、70197
- Site Reference ID/Investigator# 28133
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Wuppertal、德国、42277
- Site Reference ID/Investigator# 28126
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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 及以上 (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; Human Immunodeficiency Virus-infected participants
描述
Inclusion Criteria:
- Participants with Human Immunodeficiency Virus infection
- Participants on lopinavir/ritonavir (Kaletra) and one other protease inhibitor
Exclusion Criteria:
- Hypersensitivity against lopinavir, ritonavir or other ingredients
- Severe liver insufficiency
- No concomitant astemizole, terfenadine, oral midazolam, triazolam, cisapride, pimozide, amiodarone, ergotamine, dihydroergotamine, ergometrine, methylergometrine, vardenafil and St. John's wort
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
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
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HIV-infected participants
HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor. Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (three 133 mg/33 mg capsules twice daily or two 200 mg/50 mg tablets twice daily). |
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 |
|---|---|---|
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Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL
大体时间：Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
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Viral load (number of HIV-1 RNA copies in the blood) was measured at baseline and scheduled study visits.
A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
The percentage of participants with HIV RNA less than 50 copies/mL at each time point is presented.
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Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change From Baseline in Absolute CD4 Cell Count
大体时间：Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
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Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function.
Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
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Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
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Change From Baseline in Relative CD4 Cell Count
大体时间：Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
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Increases in relative CD4 count (the percentage of total lymphocytes that are CD4 cells) are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function.
Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the percentage of CD4+ cells at scheduled study visits.
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Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
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Change From Baseline in Absolute CD8 Cell Count
大体时间：Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
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Decreases in CD8 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function.
Changes in participants' CD8-positive (CD8+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD8+ cells at scheduled study visits.
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Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
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Change From Baseline in Relative CD8 Cell Count
大体时间：Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
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Decreases in relative CD8 count (the percentage of total lymphocytes that are CD8 cells) are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function.
Changes in participants' CD8-positive (CD8+) T-lymphocyte counts were assessed by measuring the change from Baseline in the percentage of CD8+ cells at scheduled study visits.
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Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
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Change From Baseline in CD4/CD8 T-cell Ratio
大体时间：Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
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The CD4/CD8 T-cell ratio, also known as the T-lymphocyte helper/suppressor profile, presents the number of lymphocytes in the blood positive for CD4 cells compared with the number positive for CD8 cells.
Changes in participants' CD4/CD8 T-lymphocyte ratio were assessed by measuring the change from Baseline in the ratio at scheduled study visits.
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Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
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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。
调查人员
- 研究主任：Stefan Simianer, 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
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
2004年1月1日
初级完成 (实际的)
2011年9月1日
研究完成 (实际的)
2011年9月1日
研究注册日期
首次提交
2010年2月23日
首先提交符合 QC 标准的
2010年2月23日
首次发布 (估计)
2010年2月25日
研究记录更新
最后更新发布 (估计)
2013年1月18日
上次提交的符合 QC 标准的更新
2013年1月14日
最后验证
2013年1月1日
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- P05-103
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.