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

This study has been completed.
Sponsor:
Collaborator:
Veeda Clinical Research
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01097655
First received: February 26, 2010
Last updated: May 18, 2017
Last verified: May 2017
Results First Received: January 18, 2017  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Human Immunodeficiency Virus

  Participant Flow
  Hide Participant Flow

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
HIV-infected Participants HIV-infected participants starting with Kaletra tablets.

Participant Flow:   Overall Study
    HIV-infected Participants
STARTED   3049 
COMPLETED   3039 [1] 
NOT COMPLETED   10 
Withdrawal by Subject                1 
Subject Documented Twice                1 
Did Not Meet Inclusion Criteria                8 
[1] participants included for analysis



  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
HIV-infected Participants HIV-infected participants starting with Kaletra tablets.

Baseline Measures
   HIV-infected Participants 
Overall Participants Analyzed 
[Units: Participants]
 3039 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 2896 
   40.7  (10.1) 
[1] participants with age recorded at Baseline
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 3039 
Female      595  19.6% 
Male      2444  80.4% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count   [ Time Frame: Baseline (Week 0) to Week 144 ]

2.  Primary:   Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load   [ Time Frame: Baseline (Week 0) to Week 144 ]

3.  Other Pre-specified:   Prevalence of Adverse Events (Weeks 0-144), Per Event   [ Time Frame: Weeks 0 to 144 ]

4.  Other Pre-specified:   Prevalence of Adverse Events (Weeks 0-144), Per Participant   [ Time Frame: Weeks 0 to 144 ]


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



Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01097655     History of Changes
Other Study ID Numbers: P06-131
Study First Received: February 26, 2010
Results First Received: January 18, 2017
Last Updated: May 18, 2017