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Surveillance of Kaletra in Korean Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01083173
First received: February 19, 2010
Last updated: January 25, 2016
Last verified: January 2016
Results First Received: October 30, 2015  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: HIV-1 Infection

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Main Surveillance The safety population included all participants who received at least one dose of Kaletra, and the effectiveness population included all participants who received Kaletra treatment for at least 24 weeks.
Long-term Surveillance The safety population included all participants who received Kaletra for more than 24 weeks, and the effectiveness population included all participants who received Kaletra treatment for at least 48 weeks.

Participant Flow for 4 periods

Period 1:   Main Surveillance: Safety Group
    Main Surveillance     Long-term Surveillance  
STARTED     595     0  
COMPLETED     580     0  
NOT COMPLETED     15     0  
Violation of inclusion/exclusion crit.                 14                 0  
Violation of the use/dosage                 1                 0  

Period 2:   Main Surveillance: Effectiveness Group
    Main Surveillance     Long-term Surveillance  
STARTED     580     0  
COMPLETED     198     0  
NOT COMPLETED     382     0  
No follow-up at 24 ±4 wks                 201                 0  
No viral load data at 24 ±4 wks                 168                 0  
Administration of Kaletra <24 wks                 13                 0  

Period 3:   Long-term Surveillance: Safety Group
    Main Surveillance     Long-term Surveillance  
STARTED     0     595  
COMPLETED     0     479  
NOT COMPLETED     0     116  
Violation of inclusion/exclusion crit.                 0                 14  
Violation of the dosage                 0                 1  
Administration of Kaletra <20 wks                 0                 101  

Period 4:   Long-term Surveillance: Effectiveness Gr
    Main Surveillance     Long-term Surveillance  
STARTED     0     479  
COMPLETED     0     102  
NOT COMPLETED     0     377  
No follow-up at 48 ±4 wks                 0                 195  
No viral load data at 48 ±4 wks                 0                 136  
Administration of Kaletra <48 wks                 0                 46  



  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.
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Reporting Groups
  Description
Overall Study The main surveillance safety population included all participants who received at least one dose of Kaletra. The long-term surveillance safety population included participants who received Kaletra for more than 24 weeks.

Baseline Measures
    Overall Study  
Number of Participants  
[units: participants]
  580  
Age, Customized  
[units: years]
Mean (Standard Deviation)
 
Main Surveillance n= 580     41.3  (12.5)  
Long-term Surveillance n=479     41  (12.1)  
Gender, Customized  
[units: participants]
 
Main Surveillance Females     56  
Main Surveillance Males     524  
Long-Term Surveillance Females     47  
Long-Term Surveillance Males     432  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Adverse Events   [ Time Frame: From the start of treatment until 30 days after the last dose, up to 52 weeks ]

2.  Primary:   Number of Participants Who Interrupted or Discontinued Kaletra Treatment   [ Time Frame: Weeks 24 and 48 after initiation of Kaletra treatment or upon permanent discontinuation of Kaletra treatment ]

3.  Primary:   Percentage of Participants With Viral Load Below 400 Copies/mL   [ Time Frame: Week 24 ]

4.  Primary:   Percentage of Participants With Viral Load Below 50 Copies/mL   [ Time Frame: Week 48 ]

5.  Secondary:   Change From Baseline in Viral Load   [ Time Frame: Week 24 & 48 ]

6.  Secondary:   Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Counts   [ Time Frame: From baseline to Weeks 24 and 48 ]

7.  Secondary:   Percentage of Participants With Confirmed Viral Resistance   [ Time Frame: From baseline through weeks 24 and 48 ]

8.  Secondary:   Mean Time to Treatment Failure   [ Time Frame: From baseline through weeks 24 and 48 ]


  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 Information
Organization: AbbVie (prior sponsor, Abbott)
phone: 800-633-9110



Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01083173     History of Changes
Other Study ID Numbers: P11-068
Study First Received: February 19, 2010
Results First Received: October 30, 2015
Last Updated: January 25, 2016
Health Authority: Korea: Food and Drug Administration