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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
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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 ]

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 ]
  Hide Outcome Measure 11

Measure Type Secondary
Measure Title Comparison of Mean Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension Scores From QD-KAPITAL and KAPITAL2 Studies
Measure Description Participants' perceptions of the QD and BID LPV/r regimens using data from the overall study population of QD-KAPITAL and from Cohort 2 of a 2007-2008 study, respectively (KAPITAL2, Casado et al. See Detailed Description for full reference). The KAPITAL2 cohort was comprised of HIV-infected participants treated with LPV/r BID from ≥3 months to <2 years for at least 1 month before inclusion in the study. Data for the overall study population of QD-KAPITAL are provided here, but a comparison to Cohort 2 from the KAPITAL2 study is not presented.
Time Frame at the single study visit, performed after at least 12 weeks of treatment with Kaletra  
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 evaluable data. n=the number of participants with data for given 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]
  93  
Comparison of Mean Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension Scores From QD-KAPITAL and KAPITAL2 Studies  
[units: units on a scale]
Mean ± Standard Deviation
 
Overall Satisfaction (n=92)     44.4  ± 7.6  
General/Clinical Satisfaction (n=93)     25.5  ± 4.9  
Lifestyle (n=93)     18.6  ± 4.1  

No statistical analysis provided for Comparison of Mean Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension Scores From QD-KAPITAL and KAPITAL2 Studies



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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