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Drug Use Investigation of Kaletra

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01076972
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):
Abbott
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
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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
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.

Participant Flow:   Overall Study
    Lopinavir/Ritonavir Group
STARTED   1184 
COMPLETED   1184 
NOT COMPLETED   0 



  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
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]
 1184 
Age 
[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 
Gender 
[Units: Participants]
 
Female   106 
Male   1078 
Region of Enrollment 
[Units: Participants]
 
Japan   1184 


  Outcome Measures
  Show All Outcome Measures

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


  More Information