Treatment Perception of QD (Once a Day) Dosed Kaletra (Tablets) (QD-Kapital)

This study has been completed.
Sponsor:
Collaborator:
Triaca Magna, SA
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01383005
First received: May 31, 2011
Last updated: April 30, 2013
Last verified: April 2013
Results First Received: December 28, 2012  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Cross-Sectional
Condition: Human Immunodeficiency Virus Infection

  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
97 participants were enrolled; 3 participants who did not meet the inclusion criteria for treatment duration were excluded.

Reporting Groups
  Description
Kaletra (LPV/r) QD as First Kaletra Treatment HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
Kaletra (LPV/r) QD From Kaletra BID HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD.

Participant Flow:   Overall Study
    Kaletra (LPV/r) QD as First Kaletra Treatment     Kaletra (LPV/r) QD From Kaletra BID  
STARTED     34     60  
COMPLETED     34     60  
NOT COMPLETED     0     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
Kaletra (LPV/r) QD as First Kaletra Treatment HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
Kaletra (LPV/r) QD From Kaletra BID HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD.
Total Total of all reporting groups

Baseline Measures
    Kaletra (LPV/r) QD as First Kaletra Treatment     Kaletra (LPV/r) QD From Kaletra BID     Total  
Number of Participants  
[units: participants]
  34     60     94  
Age  
[units: years]
Mean ± Standard Deviation
  36.2  ± 9.4     39.9  ± 8.8     38.6  ± 9.2  
Gender  
[units: participants]
     
Female     9     21     30  
Male     25     39     64  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores for the Overall Study Population   [ Time Frame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD ]

2.  Primary:   Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ)Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores for the Overall Study Population   [ Time Frame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD ]

3.  Secondary:   Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts   [ Time Frame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD ]

4.  Secondary:   Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores Comparison Between Cohorts   [ Time Frame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD ]

5.  Secondary:   Number of Days Without Medication, Per Simplified Medication Adherence Questionnaire (SMAQ)   [ Time Frame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD ]

6.  Secondary:   Adherence Classification of Participants Per Simplified Medication Adherence Questionnaire (SMAQ)   [ Time Frame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD ]

7.  Secondary:   Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen   [ Time Frame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD ]

8.  Secondary:   Percentage of Participants With a Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Overall Satisfaction Dimension Mean Score Value of ≥5 and <5   [ Time Frame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD ]

9.  Secondary:   Viral Load (VL) Change After at Least 12 Weeks of Treatment With the Lopinavir/Ritonavir (LPV/r)   [ Time Frame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD ]

10.  Secondary:   Mean Number of Days on LPV/r QD   [ Time Frame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD ]
  Hide Outcome Measure 10

Measure Type Secondary
Measure Title Mean Number of Days on LPV/r QD
Measure Description This independent variable was correlated with the percentage of participants with the dependent variable of an HIVTSQ Overall Satisfaction dimension mean score value of <5 (see Outcome Measure 8), to determine the factors associated with a participant's lower perception of QD LPV/r treatment (see statistical analysis for odds ratio).
Time Frame At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD  
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, per responses to the HIVTSQ Overall Satisfaction Dimension

Reporting Groups
  Description
Overall Study Population

HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.

Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD.


Measured Values
    Overall Study Population  
Number of Participants Analyzed  
[units: participants]
  92  
Mean Number of Days on LPV/r QD  
[units: days]
Mean ± Standard Deviation
  208.3  ± 161.2  


Statistical Analysis 1 for Mean Number of Days on LPV/r QD
Groups [1] Overall Study Population
Method [2] Regression, Logistic
P Value [3] 0.025
Odds Ratio (OR) [4] 0.996
95% Confidence Interval ( 0.992 to 0.999 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Statistical Analysis 1 presents the risk of a 'mean score <5' on the HIVTSQ overall satisfaction dimension (see Outcome Measure 8) when correlated with time on treatment with LPV/r QD in the last model of the Wald test.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Degree of freedom is 1 for the independent variable ‘time on LPV/r.’
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Stepwise procedures forward and backward were used to select variables in the model using entry and exit probabilities of 0.05 and 0.1 respectively. Identical models were obtained by forward and backward selection procedures.



11.  Secondary:   Comparison of Mean Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension Scores From QD-KAPITAL and KAPITAL2 Studies   [ Time Frame: at the single study visit, performed after at least 12 weeks of treatment with Kaletra ]

12.  Secondary:   Percentage of Participants With Missing Doses During “the Past 4 Days” and “the Last Weekend” in KAPITAL-2 and QD-KAPITAL Studies   [ Time Frame: at the single study visit, performed after at least 12 weeks of treatment with Kaletra ]


  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: AbbVie (prior sponsor, Abbott)
phone: 800-633-9110


No publications provided


Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01383005     History of Changes
Other Study ID Numbers: P12-752
Study First Received: May 31, 2011
Results First Received: December 28, 2012
Last Updated: April 30, 2013
Health Authority: Spain: Spanish Agency of Medicines