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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
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.

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 ]

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 ]
  Hide Outcome Measure 4

Measure Type Secondary
Measure Title Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml
Measure Description All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 RNA levels of 200 to less than 500 copies/mL at each time point is presented by subgroup.
Time Frame Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks  
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 HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure.

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  
Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml  
[units: Percentage¬†of¬†participants]
     
Baseline     0     3     0  
Week 4     18     12     19  
Week 12     12     15     17  
Week 24     3     6     4  
Week 36     1     9     6  
Week 48     1     0     13  
Week 60     2     6     9  
Week 72     0     6     8  
Week 84     2     5     3  
Week 96     0     7     7  
Week 108     0     0     0  
Week 120     2     9     0  
Week 132     3     0     0  
Week 144     0     10     0  
Week 156     NA [1]   10     0  
Week 168     NA [1]   10     0  
Week 180     NA [1]   0     8  
Week 192     NA [1]   10     0  
Week 204     NA [1]   0     0  
Week 216     NA [1]   0     0  
Week 228     NA [1]   6     0  
Week 240     NA [1]   6     0  
[1] Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.

No statistical analysis provided for Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml



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