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

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ClinicalTrials.gov Identifier: NCT01383005
Recruitment Status : Completed
First Posted : June 28, 2011
Results First Posted : April 22, 2013
Last Update Posted : May 6, 2013
Sponsor:
Collaborator:
Triaca Magna, SA
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Cross-Sectional
Condition Human Immunodeficiency Virus Infection
Enrollment 97
Recruitment Details  
Pre-assignment Details 97 participants were enrolled; 3 participants who did not meet the inclusion criteria for treatment duration were excluded.
Arm/Group Title Kaletra (LPV/r) QD as First Kaletra Treatment Kaletra (LPV/r) QD From Kaletra BID
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 34 60
Completed 34 60
Not Completed 0 0
Arm/Group Title Kaletra (LPV/r) QD as First Kaletra Treatment Kaletra (LPV/r) QD From Kaletra BID Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 34 60 94
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 60 participants 94 participants
36.2  (9.4) 39.9  (8.8) 38.6  (9.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 60 participants 94 participants
Female
9
  26.5%
21
  35.0%
30
  31.9%
Male
25
  73.5%
39
  65.0%
64
  68.1%
1.Primary Outcome
Title Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores for the Overall Study Population
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with complete data. n=number of participants with complete data for given HIVTSQ item.
Arm/Group Title Overall Study Population
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 94
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
2.Primary Outcome
Title Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ)Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores for the Overall Study Population
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with complete data. n=number of participants with complete data for given HIVTSQ item.
Arm/Group Title Overall Study Population
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 93
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
3.Secondary Outcome
Title Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with complete data. n=number of participants with complete data for given HIVTSQ item.
Arm/Group Title Kaletra (LPV/r) QD as First Kaletra Treatment Kaletra (LPV/r) QD From Kaletra BID
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 34 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
4.Secondary Outcome
Title Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores Comparison Between Cohorts
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with complete data. n=number of participants with complete data for given HIVTSQ item.
Arm/Group Title Kaletra (LPV/r) QD as First Kaletra Treatment Kaletra (LPV/r) QD From Kaletra BID
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 33 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
5.Secondary Outcome
Title Number of Days Without Medication, Per Simplified Medication Adherence Questionnaire (SMAQ)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with complete data.
Arm/Group Title Kaletra (LPV/r) QD as First Kaletra Treatment Kaletra (LPV/r) QD From Kaletra BID
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 34 59
Measure Type: Number
Unit of Measure: participants
None 30 36
One Day 3 8
More than One Day 1 15
6.Secondary Outcome
Title Adherence Classification of Participants Per Simplified Medication Adherence Questionnaire (SMAQ)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with complete data.
Arm/Group Title Kaletra (LPV/r) QD as First Kaletra Treatment Kaletra (LPV/r) QD From Kaletra BID
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 34 60
Measure Type: Number
Unit of Measure: participants
Perfect Adherence 19 28
Adequate Adherence 11 11
Poor Adherence 4 21
7.Secondary Outcome
Title Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Overall Study Population
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 94
Measure Type: Number
Unit of Measure: 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
8.Secondary Outcome
Title Percentage of Participants With a Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Overall Satisfaction Dimension Mean Score Value of ≥5 and <5
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Overall Study Population
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 93
Measure Type: Number
Unit of Measure: percentage of participants
Mean Score ≥5 54.3
Mean Score <5 45.7
9.Secondary Outcome
Title Viral Load (VL) Change After at Least 12 Weeks of Treatment With the Lopinavir/Ritonavir (LPV/r)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants, per responses to the HIVTSQ Overall Satisfaction Dimension
Arm/Group Title Overall Study Population
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 93
Measure Type: Number
Unit of Measure: participants
Detectable to Undetectable 51
Undetectable to Undetectable 16
Current Detectable 25
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall Study Population
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Regression, Logistic
Comments Degree of freedom is 1 for the independent variable ‘viral load change from detectable to undetectable.’
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.160
Confidence Interval (2-Sided) 95%
0.052 to 0.494
Estimation Comments 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.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Overall Study Population
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.072
Comments [Not Specified]
Method Regression, Logistic
Comments Degree of freedom is 1 for the independent variable ‘viral load change from undetectable to undetectable.’
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.279
Confidence Interval (2-Sided) 95%
0.070 to 1.118
Estimation Comments 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 Outcome
Title Mean Number of Days on LPV/r QD
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants, per responses to the HIVTSQ Overall Satisfaction Dimension
Arm/Group Title Overall Study Population
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 92
Mean (Standard Deviation)
Unit of Measure: days
208.3  (161.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall Study Population
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments [Not Specified]
Method Regression, Logistic
Comments Degree of freedom is 1 for the independent variable ‘time on LPV/r.’
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.996
Confidence Interval (2-Sided) 95%
0.992 to 0.999
Estimation Comments 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 Outcome
Title Comparison of Mean Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension Scores From QD-KAPITAL and KAPITAL2 Studies
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with evaluable data. n=the number of participants with data for given dimension.
Arm/Group Title Overall Study Population
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 93
Mean (Standard Deviation)
Unit of Measure: units on a scale
Overall Satisfaction (n=92) 44.4  (7.6)
General/Clinical Satisfaction (n=93) 25.5  (4.9)
Lifestyle (n=93) 18.6  (4.1)
12.Secondary Outcome
Title Percentage of Participants With Missing Doses During “the Past 4 Days” and “the Last Weekend” in KAPITAL-2 and QD-KAPITAL Studies
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with evaluable data.
Arm/Group Title Overall Study Population
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 94
Measure Type: Number
Unit of Measure: 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
Time Frame Collected at the single study visit, performed after at least 12 weeks of treatment with Kaletra QD
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Overall Study Population
Hide Arm/Group Description

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.

All-Cause Mortality
Overall Study Population
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Overall Study Population
Affected / at Risk (%)
Total   0/94 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Overall Study Population
Affected / at Risk (%)
Total   13/94 (13.83%) 
Gastrointestinal disorders   
Diarrhea  1  10/94 (10.64%) 
Nausea  1  2/94 (2.13%) 
Dyspepsia  1  1/94 (1.06%) 
General disorders   
Burning Sensation  1  2/94 (2.13%) 
Musculoskeletal and connective tissue disorders   
Musculoskeletal pain  1  2/94 (2.13%) 
Reproductive system and breast disorders   
Sexual Disorder NOS  1  1/94 (1.06%) 
Skin and subcutaneous tissue disorders   
Skin Disorders NOS  1  1/94 (1.06%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
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.
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title: Global Medical Services
Organization: AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01383005     History of Changes
Other Study ID Numbers: P12-752
First Submitted: May 31, 2011
First Posted: June 28, 2011
Results First Submitted: December 28, 2012
Results First Posted: April 22, 2013
Last Update Posted: May 6, 2013