Drug Use Investigation of Kaletra

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01076972
First received: February 25, 2010
Last updated: January 31, 2012
Last verified: January 2012
Results First Received: 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

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  
Number of Participants  
[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
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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 ]
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Measure Type Primary
Measure Title Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each Visit
Measure Description Number of HIV RNA copies per mL is presented by the mean per visit for patients that were naive to previous antiretroviral treatment and those that were not. HIV-RNA data reported as < 400 copies/mL were considered 399 copies/mL in calculations. The mean and standard deviation of HIV-RNA levels were thus calculated after logarithmic (base 10) transformation (log10 399 is 2.6). Only observed cases were included in analyses; no data were imputed. n = xx, xx is the number of treatment-naive, treatment-experienced participants who had CD4+ T-cell counts available for analysis at each study 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  
Safety Issue No  

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.
Available data at each visit for each subgroup of patients who had not received and who had received prior antiretroviral drug therapy were included in the analyses. Data for patients for whom either baseline data or treatment data were missing for a given visit were excluded from the analysis for that visit.

Reporting Groups
  Description
Lopinavir/Ritonavir: Treatment-Naive The subgroup of patients who had not received prior antiretroviral drug therapy. Data for patients for whom either baseline data or data during treatment were missing for a given time point were excluded from the analysis for that time point. Of the 1184 total enrolled patients, 416 patients had baseline data and efficacy data for this outcome measure, and were therefore included in the analysis.
Lopinavir/Ritonavir: Treatment-experienced The subgroup of patients who have received prior antiretroviral drug therapy. Data for patients for whom either baseline data or data during treatment were missing for a given time point were excluded from the analysis for that time point. Of the 1184 total enrolled patients, 418 patients had baseline data and efficacy data for this outcome measure, and were therefore included in the analysis.

Measured Values
    Lopinavir/Ritonavir: Treatment-Naive     Lopinavir/Ritonavir: Treatment-experienced  
Number of Participants Analyzed  
[units: participants]
  416     418  
Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each Visit  
[units: copies/mL]
Mean ± Standard Deviation
   
Baseline (Month 0 [n = 416, 418])     4.9  ± 0.8     3.5  ± 1.1  
Month 3 (n = 315, 280)     2.7  ± 0.4     2.8  ± 0.5  
Month 6 (n = 288, 253)     2.7  ± 0.3     2.8  ± 0.6  
Month 9 (n = 224, 238)     2.6  ± 0.3     2.8  ± 0.5  
Month 12 (Year 1 [n = 203, 230])     2.7  ± 0.4     2.8  ± 0.6  
Year 2 (n = 145, 190)     2.7  ± 0.3     2.7  ± 0.5  
Year 3 (n = 107, 147)     2.6  ± 0.1     2.7  ± 0.4  
Year 4 (n = 70, 99)     2.6  ± 0.1     2.7  ± 0.4  
Year 5 (n = 39, 72)     2.7  ± 0.3     2.8  ± 0.5  
Year 6 (n = 25, 41)     2.7  ± 0.3     2.6  ± 0.3  
Year 7 (n = 3, 17)     2.6  ± 0.0     2.8  ± 0.6  
Year 8 (n = 0, 3)     NA  ± NA [1]   2.6  ± 0.0  
[1] No data were recorded for any patients at this visit.

No statistical analysis provided for Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each Visit



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


  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.


Limitations and Caveats
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
No text entered.  


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


No publications provided


Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01076972     History of Changes
Other Study ID Numbers: PMOS-JAP-00-001
Study First Received: February 25, 2010
Results First Received: December 9, 2011
Last Updated: January 31, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare