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.
No text entered.

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
  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 ]
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Measure Type Primary
Measure Title Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs
Measure Description Standard genotypic resistance assays were developed for HIV-1 viral load levels greater than 500 to 1000 copies per milliliter (mL). All 3 protocols recommended this testing be done at Baseline prior to lopinavir/ritonavir therapy and (if possible) in cases of virologic failure. The exact timing varied and depended on whether there was an adequate viral load and physician clinical judgment. Participants with resistance to lopinavir/ritonavir, nucleoside reverse transcriptase inhibitors (NRTI) or non-nucleoside reverse transcriptase inhibitors (NNRTI) at Baseline and follow-up are reported.
Time Frame Baseline and at any timepoint where testing is possible  
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.
All participants with resistance testing at baseline and follow-up are presented.

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.

Measured Values
    Therapy-naive     Pre-treated     Non-B  
Number of Participants Analyzed  
[units: participants]
  137     92     55  
Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs  
[units: Participants]
     
Genotypic resistance testing performed at Baseline     137     68     55  
Complete resistance testing results at Baseline     122     68     55  
>Resistance to lopinavir/ritonavir at Baseline     0     2     0  
>Partial resistance to NRTI at Baseline     5     0     0  
>Partial resistance to NNRTI at Baseline     0     0     0  
Underwent resistance testing at follow-up     2     2     2  
>Resistance to lopinavir/ritonavir*     0     1     0  
>>Resistance to NRTIs     0     1     0  
>>Resistance to NNRTIs     0     0     0  
*No baseline results avail for this participant     NA [1]   1     NA [1]
[1] NA=not applicable to this subgroup.

No statistical analysis provided for Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs



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
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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.


Results Point of Contact:  
Name/Title: Global Medical Services
Organization: Abbott
phone: 1-800-633-9110


No publications provided


Responsible Party: Dr. Stefan Simianer, Medical Director, Medical Department, Abbott Germany (Wiesbaden)
ClinicalTrials.gov Identifier: NCT01083810     History of Changes
Obsolete Identifiers: NCT01081470, NCT01083836
Other Study ID Numbers: KAL 1 RO
Study First Received: February 26, 2010
Results First Received: June 30, 2011
Last Updated: August 9, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices