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Drug Use Investigation of Kaletra

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: February 26, 2010
Last Update Posted: March 1, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Results First Submitted: December 9, 2011  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Human Immunodeficiency Virus
Intervention: Drug: Lopinavir/ritonavir (Kaletra)

  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.
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Reporting Groups
Lopinavir/Ritonavir Group All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.

Baseline Measures
   Lopinavir/Ritonavir Group 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 39.7  (11.0) 
Age, Customized 
[Units: Participants]
<=14 years   4 
Between 15 and 64 years   1155 
>=65 years   25 
[Units: Participants]
Female   106 
Male   1078 
Region of Enrollment 
[Units: Participants]
Japan   1184 

  Outcome Measures
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1.  Primary:   Total Number of Patients With Adverse Drug Reactions   [ Time Frame: During the course of the survey period up to Year 8 ]

2.  Primary:   Cluster of Differentiation 4 Lymphocyte Count (CD4)   [ Time Frame: Baseline (Month 0), every 3 months thereafter up to Month 12 and every year thereafter up to Year 8 (Month 96) during the course of the survey period ]

3.  Primary:   Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each Visit   [ Time Frame: Baseline (Month 0), every 3 months thereafter up to Month 12 and every year thereafter up to Year 8 (Month 96) during the course of the survey period ]

4.  Primary:   Number of Patients Included in Each Center for Disease Control and Prevention (CDC) Classification Category for HIV-infected Adults and Adolescents   [ Time Frame: Baseline (Month 0) and following last treatment dose during the course of the survey period ]

  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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