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 ]

Measure Type Primary
Measure Title Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores for the Overall Study Population
Measure Description Participant treatment satisfaction was measured using the HIVTSQ, which consists of 10 items (1-Satisfaction, 2-HIV Control, 3-Adverse Effects, 4-Level of Demand, 5-Convenience, 6-Flexibility, 7-Knowledge, 8-Life Habits, 9-Recommendability, and 10-Willingness to Continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). Each single item was considered for the evaluation of the primary outcome.
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 with complete data. n=number of participants with complete data for given HIVTSQ item.

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]
  94  
Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores for the Overall Study Population  
[units: units on a scale]
Mean ± Standard Deviation
 
Item 1: Satisfied (n=93)     5.0  ± 1.2  
Item 2: HIV Control (n=93)     5.4  ± 1.0  
Item 3: Adverse Effects (n=93)     4.8  ± 1.3  
Item 4: Demanding (n=94)     2.4  ± 2.3  
Item 5: Convenient (n=94)     4.8  ± 1.4  
Item 6: Flexible (n=94)     4.2  ± 1.9  
Item 7: Knowledge (n=93)     4.6  ± 1.4  
Item 8: Life Habits (n=94)     4.9  ± 1.3  
Item 9: Would Recommend (n=94)     5.1  ± 1.2  
Item 10: Willing to Continue (n=94)     5.0  ± 1.5  

No statistical analysis provided for Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores for the Overall Study Population



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 ]

Measure Type Primary
Measure Title Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ)Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores for the Overall Study Population
Measure Description The HIVTSQ consists of 10 items (1-Satisfaction, 2-HIV Control, 3-Adverse Effects, 4-Level of Demand, 5-Convenience, 6-Flexibility, 7-Knowledge, 8-Life Habits, 9-Recommendability, and 10-Willingness to Continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The items are aggregated to 3 different dimensions: the Overall Satisfaction dimension, with a maximum score of 54 (items 1, 2, 3, 5, 6, 7, 8, 9 and 10); General/Clinical Satisfaction dimension, with a maximum score of 30 (items 1, 2, 3, 9 and 10); Lifestyle dimension, with a maximum score of 24 (items 5, 6, 7 and 8). Each dimension was considered for the evaluation of the primary outcome. For each participant, each dimension score was calculated as a sum of the individual item scores.
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 with complete data. n=number of participants with complete data for given HIVTSQ item.

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  
Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ)Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores for the Overall Study Population  
[units: units on a scale]
Mean ± Standard Deviation
 
Score for Overall Satisfaction (n=92)     44.4  ± 7.6  
Score for General/Clinical Satisfaction (n=93)     25.5  ± 4.9  
Score of Lifestyle (n=93)     18.6  ± 4.1  

No statistical analysis provided for Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ)Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores for the Overall Study Population



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 ]

Measure Type Secondary
Measure Title Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts
Measure Description The HIVTSQ consists of 10 items (1-Satisfaction, 2-HIV Control, 3-Adverse Effects, 4-Level of Demand, 5-Convenience, 6-Flexibility, 7-Knowledge, 8-Life Habits, 9-Recommendability, and 10-Willingness to Continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The mean score per item was compared between cohorts.
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 with complete data. n=number of participants with complete data for given HIVTSQ item.

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.

Measured Values
    Kaletra (LPV/r) QD as First Kaletra Treatment     Kaletra (LPV/r) QD From Kaletra BID  
Number of Participants Analyzed  
[units: participants]
  34     60  
Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts  
[units: units on a scale]
Mean ± Standard Deviation
   
Item 1: Satisfied (n=33, 60)     5.0  ± 27.7     5.1  ± 18.3  
Item 2: HIV Control (n=33, 60)     5.4  ± 18.1     5.5  ± 16.1  
Item 3: Adverse Effects (n=33, 60)     4.8  ± 24.0     5.1  ± 19.6  
Item 4: Demanding (n=34, 60)     2.4  ± 38.4     2.5  ± 38.3  
Item 5: Convenient (n=34, 60)     4.8  ± 24.0     5.0  ± 21.6  
Item 6: Flexible (n=34, 60)     4.2  ± 32.5     4.3  ± 30.6  
Item 7: Knowledge (n=33, 60)     4.6  ± 23.6     4.7  ± 22.1  
Item 8: Life Habits (n=34, 60)     4.9  ± 22.9     5.0  ± 21.6  
Item 9: Would Recommend (n=34, 60)     5.1  ± 21.4     5.3  ± 19.7  
Item 10: Willing to Continue (n=34, 60)     5.0  ± 26.4     5.1  ± 23.5  

No statistical analysis provided for Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts



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 ]

Measure Type Secondary
Measure Title Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores Comparison Between Cohorts
Measure Description The HIVTSQ consists of 10 items (1-Satisfaction, 2-HIV Control, 3-Adverse Effects, 4-Level of Demand, 5-Convenience, 6-Flexibility, 7-Knowledge, 8-Life Habits, 9-Recommendability, and 10-Willingness to Continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The items are aggregated to 3 different dimensions: the Overall Satisfaction dimension, with a maximum score of 54 (items 1, 2, 3, 5, 6, 7, 8, 9 and 10); General/Clinical Satisfaction dimension, with a maximum score of 30 (items 1, 2, 3, 9 and 10); Lifestyle dimension, with a maximum score of 24 (items 5, 6, 7 and 8). The mean score per dimension was compared between cohorts.
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 with complete data. n=number of participants with complete data for given HIVTSQ item.

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.

Measured Values
    Kaletra (LPV/r) QD as First Kaletra Treatment     Kaletra (LPV/r) QD From Kaletra BID  
Number of Participants Analyzed  
[units: participants]
  33     60  
Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores Comparison Between Cohorts  
[units: units on a scale]
Mean ± Standard Deviation
   
Score for Overall Satisfaction (n=32, 60)     43.3  ± 7.9     45.0  ± 7.5  
Score for General/Clinical Satisfaction (n=33, 60)     24.4  ± 5.7     26.1  ± 4.4  
Score for Lifestyle (n=33, 60)     18.2  ± 4.4     18.9  ± 3.9  

No statistical analysis provided for Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores Comparison Between Cohorts



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 ]

Measure Type Secondary
Measure Title Number of Days Without Medication, Per Simplified Medication Adherence Questionnaire (SMAQ)
Measure Description Number of days without medication was assessed by 1 of the 6 items on the patient questionnaire Simplified Medication Adherence Questionnaire (SMAQ): How many full days have you missed your medication since your last visit? (Please see Outcome Measure 6 for details regarding the remaining 5 items on the SMAQ.)
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 with complete data.

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.

Measured Values
    Kaletra (LPV/r) QD as First Kaletra Treatment     Kaletra (LPV/r) QD From Kaletra BID  
Number of Participants Analyzed  
[units: participants]
  34     59  
Number of Days Without Medication, Per Simplified Medication Adherence Questionnaire (SMAQ)  
[units: participants]
   
None     30     36  
One Day     3     8  
More than One Day     1     15  

No statistical analysis provided for Number of Days Without Medication, Per Simplified Medication Adherence Questionnaire (SMAQ)



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 ]

Measure Type Secondary
Measure Title Adherence Classification of Participants Per Simplified Medication Adherence Questionnaire (SMAQ)
Measure Description Participants' adherence was classified according to answers for 5 of 6 items on the participant questionnaire Simplified Medication Adherence Questionnaire (SMAQ): 4 yes/no questions: Do you ever forget to take your medicines? Do you take your medicines at the instructed time? If you ever feel ill, do you stop taking the medication? Have you ever missed your medication during weekends?; plus the following: In the past week, how many times have you missed your medication? (0, 1-2, 3-5, 6-10, >10). (Please see Outcome Measure 5 for details regarding the 6th item on the SMAQ.) Perfect adherence = no dose was forgotten, medication was not skipped for any reason, and the schedule was not modified; adequate adherence = no dose was forgotten, but at least one dose was not taken at the indicated time; poor adherence = one or more doses were not taken.
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 with complete data.

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.

Measured Values
    Kaletra (LPV/r) QD as First Kaletra Treatment     Kaletra (LPV/r) QD From Kaletra BID  
Number of Participants Analyzed  
[units: participants]
  34     60  
Adherence Classification of Participants Per Simplified Medication Adherence Questionnaire (SMAQ)  
[units: participants]
   
Perfect Adherence     19     28  
Adequate Adherence     11     11  
Poor Adherence     4     21  

No statistical analysis provided for Adherence Classification of Participants Per Simplified Medication Adherence Questionnaire (SMAQ)



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 ]

Measure Type Secondary
Measure Title Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen
Measure Description Participants’ cumulative reasons for starting or switching to a LPV/r QD regimen were tabulated via the following yes/no questions entered on the case report form by the physician: simplification (simp) as reason to change to LPV/r QD; preference (pref) of patient as reason to change to LPV/r QD; adjustment to other antiretrovirals (adjust to ARV) as reason to change to LPV/r QD; adherence as reason to change to LPV/r QD; patient’s lifestyle as reason to change to LPV/r QD; tolerability as reason to change to LPV/r QD.
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

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]
  94  
Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen  
[units: participants]
 
Simp+ Pref + Adjust to ARV + Adherence + Lifestyle     2  
Simp + Pref + Adjust to ARV + Adherence     3  
Simp + Pref + Adjust to ARV + Lifestyle     1  
Simp+ Pref + Adherence + Lifestyle     3  
Simp + Pref + Adherence     4  
Simp + Pref + Lifestyle     2  
Simp + Pref     3  
Simp + Adjust to ARV + Adherence + Lifestyle     2  
Simp + Adjust to ARV + Adherence     5  
Simp + Adjust to ARV + Lifestyle     1  
Simp + Adjust to ARV     1  
Simp + Adherence + Lifestyle + Tolerability     1  
Simp + Adherence + Lifestyle     6  
Simp + Adherence     12  
Simp + Lifestyle     1  
Simp + Tolerability     1  
Simp     18  
Pref + Adjust to ARV + Adherence + Lifestyle     1  
Pref + Adjust to ARV     1  
Pref + Adherence + Lifestyle     1  
Pref + Adherence     1  
Pref     4  
Adjust to ARV + Adherence + Lifestyle     1  
Adjust to ARV + Lifestyle     3  
Adjust to ARV     1  
Adherence + Lifestyle + Tolerability     1  
Adherence + Lifestyle     5  
Adherence     6  
Lifestyle     3  

No statistical analysis provided for Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen



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 ]

Measure Type Secondary
Measure Title Percentage of Participants With a Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Overall Satisfaction Dimension Mean Score Value of ≥5 and <5
Measure Description The HIVTSQ consists of 10 items (1-Satisfaction, 2-HIV Control, 3-Adverse Effects, 4-Level of Demand, 5-Convenience, 6-Flexibility, 7-Knowledge, 8-Life Habits, 9-Recommendability, and 10-Willingness to Continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The items are aggregated to 3 different dimensions. The Overall Satisfaction dimension has a maximum score of 54 (items 1, 2, 3, 5, 6, 7, 8, 9 and 10). The mean of the individual item scores were dichotomized as 'mean score <5 (lower participant perception of LPV/r QD)' and 'mean score ≥5 (high or very high participant perception of LPV/r QD).' The dependent variable of a mean score <5 was correlated with the independent variables of viral load and time on treatment (see Outcome Measures 9 and 10), to determine the factors associated with a participant's lower perception of QD LPV/r treatment.
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

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  
Percentage of Participants With a Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Overall Satisfaction Dimension Mean Score Value of ≥5 and <5  
[units: percentage of participants]
 
Mean Score ≥5     54.3  
Mean Score <5     45.7  

No statistical analysis provided for Percentage of Participants With a Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Overall Satisfaction Dimension Mean Score Value of ≥5 and <5



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 ]

Measure Type Secondary
Measure Title Viral Load (VL) Change After at Least 12 Weeks of Treatment With the Lopinavir/Ritonavir (LPV/r)
Measure Description Viral load change was categorized as either 'detectable to undetectable,' 'undetectable to undetectable,' or 'current detectable' (includes participants whose viral load changed from undetectable to detectable and those whose viral load was detectable throughout). This independent variable was correlated with the percentage of participants with the dependent variable of a Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (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 analyses 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]
  93  
Viral Load (VL) Change After at Least 12 Weeks of Treatment With the Lopinavir/Ritonavir (LPV/r)  
[units: participants]
 
Detectable to Undetectable     51  
Undetectable to Undetectable     16  
Current Detectable     25  


Statistical Analysis 1 for Viral Load (VL) Change After at Least 12 Weeks of Treatment With the Lopinavir/Ritonavir (LPV/r)
Groups [1] Overall Study Population
Method [2] Regression, Logistic
P Value [3] 0.001
Odds Ratio (OR) [4] 0.160
95% Confidence Interval ( 0.052 to 0.494 )
[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 a viral load change from 'detectable to undetectable' 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 ‘viral load change from detectable to undetectable.’
[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.

Statistical Analysis 2 for Viral Load (VL) Change After at Least 12 Weeks of Treatment With the Lopinavir/Ritonavir (LPV/r)
Groups [1] Overall Study Population
Method [2] Regression, Logistic
P Value [3] 0.072
Odds Ratio (OR) [4] 0.279
95% Confidence Interval ( 0.070 to 1.118 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Statistical Analysis 2 presents the risk of a 'mean score <5' on the HIVTSQ overall satisfaction dimension (see Outcome Measure 8) when correlated with a viral load change from 'undetectable to undetectable' 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 ‘viral load change from undetectable to undetectable.’
[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.



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 ]

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 ]

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 ]

Measure Type Secondary
Measure Title Percentage of Participants With Missing Doses During “the Past 4 Days” and “the Last Weekend” in KAPITAL-2 and QD-KAPITAL Studies
Measure Description Adherence to LPV/r QD therapy (overall study population of QD-KAPITAL) compared with that of LPV/r BID therapy using data of Cohort 2 from 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. (A full comparison of the adherence between the QD-KAPITAL study and the KAPITAL2 study could not be made due to formal differences in the applied adherence questionnaires; therefore, the above in-common specified item was compared.) 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.

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]
  94  
Percentage of Participants With Missing Doses During “the Past 4 Days” and “the Last Weekend” in KAPITAL-2 and QD-KAPITAL Studies  
[units: percentage of participants]
 
No Missing Doses During Past 4 days     90.4  
≥1 Missing Doses During Past 4 days     9.6  
No Missing Doses During Last Weekend     90.4  
≥1 Missing Doses During Last Weekend     9.6  

No statistical analysis provided for Percentage of Participants With Missing Doses During “the Past 4 Days” and “the Last Weekend” in KAPITAL-2 and QD-KAPITAL Studies




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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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