Evaluation of Kaletra Therapy Over the Long-term

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT01083810
First received: February 26, 2010
Last updated: August 9, 2011
Last verified: August 2011
Results First Received: 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  
Number of Participants  
[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
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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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