Multicountry, Multicenter Post-Marketing Observational Study of Clinical, Biological and Virological Outcomes, Compliance and Tolerability of Kaletra® in Routine Clinical Use (KaleEAST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01379703
First received: June 22, 2011
Last updated: October 10, 2011
Last verified: October 2011
Results First Received: August 9, 2011  
Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: HIV-1 Patients

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Total Study Population HIV-1 infected participants who received lopinavir/ritonavir (any formulation) during any part of the study.

Baseline Measures
    Total Study Population  
Number of Participants  
[units: participants]
  2288  
Age  
[units: years]
Mean ± Standard Deviation
  32.6  ± 11.0  
Gender, Customized  
[units: Participants]
 
Female     867  
Male     1419  
Data not reported     2  
Region of Enrollment  
[units: participants]
 
Serbia     149  
Czech Republic     107  
Slovenia     123  
Slovakia     26  
Poland     381  
Ukraine     266  
Romania     422  
Lithuania     3  
Russian Federation     644  
Israel     139  
Georgia     10  
Latvia     18  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   CD4 Count   [ Time Frame: Baseline ]

2.  Primary:   Changes in CD4 Count   [ Time Frame: Baseline to 1 month ]

3.  Primary:   Changes in CD4 Count   [ Time Frame: Baseline to 3 months ]

4.  Primary:   Changes in CD4 Count   [ Time Frame: Baseline to 6 months ]

5.  Primary:   Changes in CD4 Count   [ Time Frame: Baseline to 9 months ]

6.  Primary:   Changes in CD4 Count   [ Time Frame: Baseline to 12 months ]

7.  Primary:   Changes in CD4 Count   [ Time Frame: Baseline to 15 months ]

8.  Primary:   Changes in CD4 Count   [ Time Frame: Baseline to 18 months ]

9.  Primary:   Viral Load   [ Time Frame: Baseline ]

10.  Primary:   Viral Load   [ Time Frame: 1 month ]

11.  Primary:   Viral Load   [ Time Frame: 3 months ]

12.  Primary:   Viral Load   [ Time Frame: 6 months ]

13.  Primary:   Viral Load   [ Time Frame: 9 months ]

14.  Primary:   Viral Load   [ Time Frame: 12 months ]

15.  Primary:   Viral Load   [ Time Frame: 15 months ]

16.  Primary:   Viral Load   [ Time Frame: 18 months ]

17.  Primary:   Laboratory Parameter Blood Glucose   [ Time Frame: Baseline, 9 months, 18 months ]

18.  Primary:   Laboratory Parameter Transaminases   [ Time Frame: Baseline, 9 months, 18 months ]

19.  Primary:   Laboratory Parameter Lipids   [ Time Frame: Baseline, 9 months, 18 months ]

20.  Secondary:   Reasons for Discontinuation of Lopinavir/Ritonavir   [ Time Frame: 9 months ]

21.  Secondary:   Reasons for Discontinuation of Lopinavir/Ritonavir   [ Time Frame: 18 months ]

22.  Secondary:   Compliance With Lopinavir/Ritonavir   [ Time Frame: 9 months ]

23.  Secondary:   Compliance With Lopinavir/Ritonavir   [ Time Frame: 18 months ]

24.  Secondary:   Adverse Events Observed on Treatment With Lopinavir/Ritonavir.   [ Time Frame: 18 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Global Medical Services
Organization: Abbott
phone: 1-800-633-9110


No publications provided


Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01379703     History of Changes
Other Study ID Numbers: PMOS-EAST-04-1
Study First Received: June 22, 2011
Results First Received: August 9, 2011
Last Updated: October 10, 2011
Health Authority: Romania: Ethics Committee
Romania: National Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Serbia: Ethics Committee
Israel: Ethics Commission
Israel: Ministry of Health
Slovenia: Ethics Committee
Slovak Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Latvia: Institutional Review Board
Latvia: State Agency of Medicines
Lithuania: Bioethics Committee
Lithuania: State Medicine Control Agency - Ministry of Health