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


  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
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 ]

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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