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Evaluation of Kaletra Therapy Over the Long-term

2011年8月9日 更新者：Abbott
Long term observation of patients under lopinavir/ritonavir containing therapy

研究概览

地位

完全的

条件

干预/治疗

详细说明

Three to five year observation of lopinavir/ritonavir therapy. Reporting groups are 1) therapy-naïve patients (144 weeks), 2) therapy-experienced but protease inhibitor naïve patients (240 weeks,) and 3) non-B subtype infected patients (240 weeks).

These three groups of participants with HIV-1 infection were at first registered as three different studies: KAL1RO (this study, NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55) but were now reconciled under KAL1RO (NCT01083810) as a single study with three reporting groups.

研究类型

观察性的

注册 (实际的)

284

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

  • 德国
      • Aachen、德国、52062
        • Site Ref # / Investigator 27706
      • Aachen、德国、52062
        • Site Ref # / Investigator 52972
      • Berlin、德国、10117
        • Site Ref # / Investigator 27660
      • Berlin、德国、10117
        • Site Ref # / Investigator 27937
      • Berlin、德国、10117
        • Site Ref # / Investigator 52973
      • Berlin、德国、10243
        • Site Reference ID/Investigator# 27629
      • Berlin、德国、10439
        • Site Ref # / Investigator 27651
      • Berlin、德国、10439
        • Site Ref # / Investigator 27912
      • Berlin、德国、10439
        • Site Reference ID/Investigator# 27544
      • Berlin、德国、10551
        • Site Reference ID/Investigator# 27567
      • Berlin、德国、10589
        • Site Ref # / Investigator 27929
      • Berlin、德国、10707
        • Site Ref # / Investigator 52971
      • Berlin、德国、10707
        • Site Ref # / Investigator 53468
      • Berlin、德国、10777
        • Site Ref # / Investigator 27965
      • Berlin、德国、10777
        • Site Reference ID/Investigator# 27547
      • Berlin、德国、10777
        • Site Reference ID/Investigator# 27552
      • Berlin、德国、10777
        • Site Reference ID/Investigator# 27562
      • Berlin、德国、10961
        • Site Ref # / Investigator 52984
      • Berlin、德国、13347
        • Site Ref # / Investigator 27639
      • Berlin、德国、13347
        • Site Ref # / Investigator 52970
      • Berlin、德国、D-10243
        • Site Ref # / Investigator 27909
      • Berlin、德国、D-10243
        • Site Ref # / Investigator 47113
      • Chemnitz、德国、09113
        • Site Reference ID/Investigator# 27574
      • Cologne、德国、50674
        • Site Ref # / Investigator 28060
      • Cologne、德国、50674
        • Site Ref # / Investigator 52978
      • Cologne、德国、50679
        • Site Ref # / Investigator 27932
      • Cologne、德国、50679
        • Site Ref # / Investigator 52979
      • Cologne、德国、50931
        • Site Ref # / Investigator 48233
      • Cologne、德国、50931
        • Site Ref # / Investigator 52985
      • Cologne、德国、50931
        • Site Ref # / Investigator 53464
      • Dortmund、德国、44137
        • Site Ref # / Investigator 27704
      • Dortmund、德国、44137
        • Site Ref # / Investigator 27947
      • Dortmund、德国、44137
        • Site Ref # / Investigator 52968
      • Duesseldorf、德国、40237
        • Site Ref # / Investigator 28056
      • Duisburg、德国、47259
        • Site Reference ID/Investigator# 27558
      • Frankfurt、德国、15232
        • Site Ref # / Investigator 52983
      • Frankfurt、德国、60311
        • Site Ref # / Investigator 27928
      • Frankfurt、德国、60311
        • Site Ref # / Investigator 52967
      • Freiburg、德国、79106
        • Site Reference ID/Investigator# 27565
      • Fuerth、德国、90762
        • Site Reference ID/Investigator# 27566
      • Fuerth、德国、D-90762
        • Site Ref # / Investigator 53465
      • Hamburg、德国、20099
        • Site Ref # / Investigator 27931
      • Hamburg、德国、20099
        • Site Ref # / Investigator 27982
      • Hamburg、德国、20099
        • Site Ref # / Investigator 47114
      • Hamburg、德国、20099
        • Site Ref # / Investigator 47115
      • Hamburg、德国、20099
        • Site Reference ID/Investigator# 27551
      • Hamburg、德国、20099
        • Site Reference ID/Investigator# 27634
      • Hamburg、德国、20146
        • Site Ref # / Investigator 30864
      • Hamburg、德国、20146
        • Site Ref # / Investigator 5348
      • Hamburg、德国、20146
        • Site Reference ID/Investigator# 27546
      • Hamburg、德国、20246
        • Site Ref # / Investigator 28032
      • Hamburg、德国、20246
        • Site Ref # / Investigator 52969
      • Hamburg、德国、20246
        • Site Ref # / Investigator 53467
      • Hamburg、德国、20354
        • Site Ref # / Investigator 52980
      • Karlsruhe、德国、76135
        • Site Ref # / Investigator 27641
      • Karlsruhe、德国、76135
        • Site Ref # / Investigator 27964
      • Karlsruhe、德国、76135
        • Site Reference ID/Investigator# 27561
      • Koblenz、德国、56065
        • Site Ref # / Investigator 53466
      • Koblenz、德国、56065
        • Site Reference ID/Investigator# 27555
      • Krefeld、德国、47800
        • Site Ref # / Investigator 27905
      • Leipzig、德国、04107
        • Site Ref # / Investigator 27906
      • Leipzig、德国、04107
        • Site Ref # / Investigator 52975
      • Leipzig、德国、04107
        • Site Ref # / Investigator 53463
      • Ludwigshafen、德国、67063
        • Site Ref # / Investigator 27948
      • Ludwigshafen、德国、67063
        • Site Ref # / Investigator 52977
      • Mainz、德国、55116
        • Site Ref # / Investigator 27902
      • Mainz、德国、55116
        • Site Reference ID/Investigator# 27543
      • Moenchengladbach、德国、41061
        • Site Ref # / Investigator 28104
      • Moenchengladbach、德国、41061
        • Site Ref # / Investigator 52981
      • Muenster、德国、48149
        • Site Ref # / Investigator 27648
      • Muenster、德国、48149
        • Site Reference ID/Investigator# 27568
      • Munich、德国、80337
        • Site Ref # / Investigator 27949
      • Munich、德国、80337
        • Site Reference ID/Investigator# 27553
      • Munich、德国、80801
        • Site Ref # / Investigator 27926
      • Munich、德国、80801
        • Site Ref # / Investigator 53462
      • Nuernberg、德国、90419
        • Site Ref # / Investigator 52982
      • Oldenburg、德国、26121
        • Site Ref # / Investigator 27988
      • Oldenburg、德国、26121
        • Site Reference ID/Investigator# 27563
      • Osnabrueck、德国、49076
        • Site Ref # / Investigator 27637
      • Osnabrueck、德国、49076
        • Site Ref # / Investigator 27943
      • Osnabrueck、德国、49076
        • Site Ref # / Investigator 52974
      • Paderborn、德国、33100
        • Site Ref # / Investigator 27939
      • Rostock、德国、18057
        • Site Ref # / Investigator 27649
      • Rostock、德国、D-18057
        • Site Reference ID/Investigator# 27569
      • Stuttgart、德国、70197
        • Site Ref # / Investigator 27647
      • Stuttgart、德国、70197
        • Site Ref # / Investigator 28047
      • Stuttgart、德国、70197
        • Site Ref # / Investigator 28048
      • Stuttgart、德国、70197
        • Site Reference ID/Investigator# 27631
      • Troisdorf、德国、53840
        • Site Ref # / Investigator 52976
      • Wuppertal、德国、42277
        • Site Ref # / Investigator 27961

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

Human Immunodeficiency Virus-infected, protease inhibitor-naïve patients from a clinical setting

描述

Inclusion Criteria:

  • Patients infected by HIV-1
  • Age greater than or equal to 18 years

Exclusion Criteria:

  • as described in SmPC (summary of product characteristics) at the time of prescription

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

队列和干预

团体/队列
干预/治疗
therapy-naive
Patients who had not received prior antiretroviral drug therapy
药品：Lopinavir/Ritonavir (Kaletra)
3 capsules 2xdaily or 2 tablets 2xdaily Kaletra
其他名称：
  • 克力芝
  • 洛匹那韦/利托那韦
  • ABT-378/r
pre-treated
Patients that had previously received antiretroviral therapy, but are protease inhibitor naive
药品：Lopinavir/Ritonavir (Kaletra)
3 capsules 2xdaily or 2 tablets 2xdaily Kaletra
其他名称：
  • 克力芝
  • 洛匹那韦/利托那韦
  • ABT-378/r
non-B
Patients infected with non-B subtypes of HIV-1
药品：Lopinavir/Ritonavir (Kaletra)
3 capsules 2xdaily or 2 tablets 2xdaily Kaletra
其他名称：
  • 克力芝
  • 洛匹那韦/利托那韦
  • ABT-378/r

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
Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs
大体时间：Baseline and at any timepoint where testing is possible
Standard genotypic resistance assays were developed for HIV-1 viral load levels greater than 500 to 1000 copies per milliliter (mL). All 3 protocols recommended this testing be done at Baseline prior to lopinavir/ritonavir therapy and (if possible) in cases of virologic failure. The exact timing varied and depended on whether there was an adequate viral load and physician clinical judgment. Participants with resistance to lopinavir/ritonavir, nucleoside reverse transcriptase inhibitors (NRTI) or non-nucleoside reverse transcriptase inhibitors (NNRTI) at Baseline and follow-up are reported.
Baseline and at any timepoint where testing is possible

次要结果测量

结果测量
措施说明
大体时间
Percentage of Patients With HIV-1 RNA <50 Copies/ml
大体时间：Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 ribonucleic acid (RNA) less than 50 copies/mL at each time point is presented by subgroup.
Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml
大体时间：Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 RNA levels of 50 to less than 200 copies/mL at each time point is presented by subgroup.
Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml
大体时间：Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 RNA levels of 200 to less than 500 copies/mL at each time point is presented by subgroup.
Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
Percentage of Patients With HIV-1 RNA >500 Copies/ml
大体时间：Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with more than 500 HIV-1 RNA copies/mL at each time point is presented by subgroup.
Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
Change in Absolute CD4 Cell Count [CD4+ Cells/µL]
大体时间：Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
The evolution of participants' CD4-positive (CD4+) T-lymphocyte counts after starting the lopinavir/ritonavir-containing regimen was to be assessed by measuring the number of CD4+ cells at baseline and each subsequent study visit. Study visits were to occur at approximately Weeks 4, 12, 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. CD4+ cell count results are reported as the change from Baseline in the absolute number of CD4+ cells per microliter.
Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks

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

Abbott

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

2001年6月1日

初级完成 (实际的)

2010年6月1日

研究完成 (实际的)

2010年6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8日

首次发布 (估计)

2010年3月10日

研究记录更新

最后更新发布 (估计)

2011年8月11日

上次提交的符合 QC 标准的更新

2011年8月9日

最后验证

2011年8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

  • KAL 1 RO

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.

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