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Evaluation of Kaletra Therapy Over the Long-term

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01083810
First Posted: March 10, 2010
Last Update Posted: August 11, 2011
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:
Abbott
Results First Submitted: June 30, 2011  
Study Type: Observational
Study Design: Observational Model: Case-Only;   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
These three groups of participants with HIV-1 infection were at first registered as three different studies: KAL1RO (this study, NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55) but were now reconciled under KAL1RO (NCT01083810) as a single study with three reporting groups.

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
Therapy-naive Participants who had not received prior antiretroviral drug therapy.
Pre-treated Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
Non-B Participants infected with non-B subtypes of HIV-1.

Participant Flow:   Overall Study
    Therapy-naive   Pre-treated   Non-B
STARTED   137   92   55 
COMPLETED   72   47   35 
NOT COMPLETED   65   45   20 
Lost to Follow-up                23                11                4 
Adverse Event                15                11                4 
Withdrawal by Subject                7                2                4 
Reason not reported                6                1                1 
Non-compliance                4                7                2 
Simplification                4                1                0 
Death                2                2                3 
Co-morbidities                1                0                0 
Participation in study                1                0                0 
Therapy break                1                2                2 
Virologic failure                1                8                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.
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Reporting Groups
  Description
Therapy-naive Participants who had not received prior antiretroviral drug therapy.
Pre-treated Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
Non-B Participants infected with non-B subtypes of HIV-1.
Total Total of all reporting groups

Baseline Measures
   Therapy-naive   Pre-treated   Non-B   Total 
Overall Participants Analyzed 
[Units: Participants]
 137   92   55   284 
Age, Customized 
[Units: Participants]
       
>= 18 years of age (exact age not reported)   137   92   55   284 
Gender, Customized 
[Units: Participants]
       
Female   17   11   20   48 
Male   119   81   35   235 
Gender not reported   1   0   0   1 
Region of Enrollment 
[Units: Participants]
       
Germany   137   92   55   284 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs   [ Time Frame: Baseline and at any timepoint where testing is possible ]

2.  Secondary:   Percentage of Patients With HIV-1 RNA <50 Copies/ml   [ Time Frame: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks ]

3.  Secondary:   Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml   [ Time Frame: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks ]

4.  Secondary:   Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml   [ Time Frame: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks ]

5.  Secondary:   Percentage of Patients With HIV-1 RNA >500 Copies/ml   [ Time Frame: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks ]

6.  Secondary:   Change in Absolute CD4 Cell Count [CD4+ Cells/µL]   [ Time Frame: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks ]


  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