QD-Kapital: Treatment Perception of QD (Once a Day) Dosed Kaletra (Tablets)
Study Details
Study Description
Brief Summary
Both twice-a-day (BID) and once-a-day (QD) dosing are approved in Europe for the protease inhibitor lopinavir/ritonavir (LPV/r; Kaletra®).
Since once-a-day dosing is actually a driver for human immunodeficiency virus (HIV)-infected patients to request a specific antiretroviral, the aim of this study is to assess both patient's perception of and adherence to Kaletra once-a-day, as well as with which factors they are related.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Detailed Description
This is a multicenter, post-marketing, observational, cross-sectional (single visit) study in HIV-infected patients treated with a combination of antiretroviral treatment (ART) containing LPV/r 200/50 mg tablets dosed QD for at least 12 weeks to assess the participants' satisfaction and adherence level with LPV/r QD ART as measured by specific validated participant questionnaires.
As this is a non-interventional study, the decision to enroll a participant was separate from the decision to treat the subject with LPV/r. Prescription of LPV/r and duration of treatment were the responsibility of the treating physician.
In addition, the overall study population was compared to Cohort 2 (394 patients on LPV/r BID for ≥3 months to <2 years) from KAPITAL2, a post-marketing observational, cross-sectional, single visit, multicenter, national study. For further details on this study, please see: Casado JL, Griffa L, Cabrero E, Burgos A, Norton M and the KAPITAL 2 Collaborative Group. A study of treatment satisfaction reported by patients on lopinavir/r anchored regimens and physicians who provide HIV care (KAPITAL 2). 9th International Congress on Drug Therapy in HIV Infection. 9th International Congress on Drug Therapy in HIV Infection. Glasgow, 2008.#P080.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Outcome Measures
Primary Outcome Measures
- Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores for the Overall Study Population [At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD]
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.
- Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ)Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores for the Overall Study Population [At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD]
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.
Secondary Outcome Measures
- Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts [At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD]
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.
- Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores Comparison Between Cohorts [At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD]
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.
- Number of Days Without Medication, Per Simplified Medication Adherence Questionnaire (SMAQ) [At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD]
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.)
- Adherence Classification of Participants Per Simplified Medication Adherence Questionnaire (SMAQ) [At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD]
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.
- Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen [At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD]
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.
- Percentage of Participants With a Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Overall Satisfaction Dimension Mean Score Value of ≥5 and <5 [At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD]
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.
- Viral Load (VL) Change After at Least 12 Weeks of Treatment With the Lopinavir/Ritonavir (LPV/r) [At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD]
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).
- Mean Number of Days on LPV/r QD [At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD]
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).
- Comparison of Mean Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension Scores From QD-KAPITAL and KAPITAL2 Studies [at the single study visit, performed after at least 12 weeks of treatment with Kaletra]
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.
- Percentage of Participants With Missing Doses During "the Past 4 Days" and "the Last Weekend" in KAPITAL-2 and QD-KAPITAL Studies [at the single study visit, performed after at least 12 weeks of treatment with Kaletra]
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.
Eligibility Criteria
Criteria
Inclusion criteria:
-
Men or women aged 18 years or older, HIV-infected.
-
Patients who were under LPV/r Highly Active Anti-Retroviral Therapy (HAART) for 3 to 24 months before study visit:
Cohort 1: patients on LPV/r QD since they started the LPV/r regimen and who were naïve to protease inhibitor (PI) therapy.* Cohort 2: patients who previously started on LPV/r BID (maximum of 24 months before study) and switched to LPV/r QD (at least 3 months before the study visit).*
-
Patients who were able to complete questionnaires by themselves.
-
Patients who signed/dated informed consent to participate in the study.
- NOTE: Patients who were taking LPV/r QD should have had no more than 3 protease inhibitor mutations by the time the treatment with this LPV/r dosing was initiated.
Exclusion criteria:
-
Patients who were on LPV/r monotherapy or bi-therapy or on BID dosing at time of study visit.
-
Patients who were using another LPV/r formulation different from 200/50 LPV/r mg tablets.
-
Patients who were participating in any other clinical trial or postmarketing observational study (PMOS).
-
Patients who were unable to read and/or write.
-
Patients who were under treatment interruption. Patients who have stopped LPV-therapy for more than 3 months in the 12 months preceding study visit.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Site Ref # / Investigator 52274 | A Coruna | Spain | 15006 | |
| 2 | Site Ref # / Investigator 52363 | Barakaldo | Spain | 48903 | |
| 3 | Site Ref # / Investigator 52271 | Barcelona | Spain | 08035 | |
| 4 | Site Ref # / Investigator 52270 | Barcelona | Spain | 8036 | |
| 5 | Site Ref # / Investigator 52362 | Cartagena | Spain | 30203 | |
| 6 | Site Ref # / Investigator 53650 | Castellon de la Plana | Spain | 12004 | |
| 7 | Site Ref # / Investigator 52273 | Ferrol (A Coruna) | Spain | 15405 | |
| 8 | Site Ref # / Investigator 52264 | Granada | Spain | 18014 | |
| 9 | Site Ref # / Investigator 52267 | Hospitalet de Llobregat | Spain | 08906 | |
| 10 | Site Ref # / Investigator 52262 | Jaen | Spain | 23007 | |
| 11 | Site Ref # / Investigator 52263 | Jerez de la Frontera (Cadiz) | Spain | 11407 | |
| 12 | Site Ref # / Investigator 52345 | Madrid | Spain | 28007 | |
| 13 | Site Ref # / Investigator 52275 | Madrid | Spain | 28034 | |
| 14 | Site Ref # / Investigator 52302 | Madrid | Spain | 28046 | |
| 15 | Site Ref # / Investigator 52343 | Madrid | Spain | 28880 | |
| 16 | Site Ref # / Investigator 52344 | Madrid | Spain | 28905 | |
| 17 | Site Ref # / Investigator 53648 | Murcia | Spain | 30003 | |
| 18 | Site Ref # / Investigator 52268 | Reus (Tarragona) | Spain | 43201 | |
| 19 | Site Ref # / Investigator 52272 | Valencia | Spain | 46009 | |
| 20 | Site Ref # / Investigator 52266 | Zaragoza | Spain | 50009 |
Sponsors and Collaborators
- AbbVie (prior sponsor, Abbott)
- Triaca Magna, SA
Investigators
- Study Director: Angel Burgos, PhD, AbbVie S.L.U.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- P12-752
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 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 |
|---|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | Kaletra (LPV/r) QD as First Kaletra Treatment | Kaletra (LPV/r) QD From Kaletra BID | Total |
|---|---|---|---|
| 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 Participants | 34 | 60 | 94 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
36.2
(9.4)
|
39.9
(8.8)
|
38.6
(9.2)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
9
26.5%
|
21
35%
|
30
31.9%
|
| Male |
25
73.5%
|
39
65%
|
64
68.1%
|
Outcome Measures
| Title | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores for the Overall Study Population |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|
| 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. |
| Measure Participants | 94 |
| 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)
|
| Title | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 34 | 60 |
| 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)
|
| Title | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ)Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores for the Overall Study Population |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|
| 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. |
| Measure Participants | 93 |
| 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)
|
| Title | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores Comparison Between Cohorts |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 33 | 60 |
| 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)
|
| Title | Number of Days Without Medication, Per Simplified Medication Adherence Questionnaire (SMAQ) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 34 | 59 |
| None |
30
88.2%
|
36
60%
|
| One Day |
3
8.8%
|
8
13.3%
|
| More than One Day |
1
2.9%
|
15
25%
|
| Title | Adherence Classification of Participants Per Simplified Medication Adherence Questionnaire (SMAQ) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 34 | 60 |
| Perfect Adherence |
19
55.9%
|
28
46.7%
|
| Adequate Adherence |
11
32.4%
|
11
18.3%
|
| Poor Adherence |
4
11.8%
|
21
35%
|
| Title | Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants |
| Arm/Group Title | Overall Study Population |
|---|---|
| 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. |
| Measure Participants | 94 |
| Simp+ Pref + Adjust to ARV + Adherence + Lifestyle |
2
5.9%
|
| Simp + Pref + Adjust to ARV + Adherence |
3
8.8%
|
| Simp + Pref + Adjust to ARV + Lifestyle |
1
2.9%
|
| Simp+ Pref + Adherence + Lifestyle |
3
8.8%
|
| Simp + Pref + Adherence |
4
11.8%
|
| Simp + Pref + Lifestyle |
2
5.9%
|
| Simp + Pref |
3
8.8%
|
| Simp + Adjust to ARV + Adherence + Lifestyle |
2
5.9%
|
| Simp + Adjust to ARV + Adherence |
5
14.7%
|
| Simp + Adjust to ARV + Lifestyle |
1
2.9%
|
| Simp + Adjust to ARV |
1
2.9%
|
| Simp + Adherence + Lifestyle + Tolerability |
1
2.9%
|
| Simp + Adherence + Lifestyle |
6
17.6%
|
| Simp + Adherence |
12
35.3%
|
| Simp + Lifestyle |
1
2.9%
|
| Simp + Tolerability |
1
2.9%
|
| Simp |
18
52.9%
|
| Pref + Adjust to ARV + Adherence + Lifestyle |
1
2.9%
|
| Pref + Adjust to ARV |
1
2.9%
|
| Pref + Adherence + Lifestyle |
1
2.9%
|
| Pref + Adherence |
1
2.9%
|
| Pref |
4
11.8%
|
| Adjust to ARV + Adherence + Lifestyle |
1
2.9%
|
| Adjust to ARV + Lifestyle |
3
8.8%
|
| Adjust to ARV |
1
2.9%
|
| Adherence + Lifestyle + Tolerability |
1
2.9%
|
| Adherence + Lifestyle |
5
14.7%
|
| Adherence |
6
17.6%
|
| Lifestyle |
3
8.8%
|
| Title | Percentage of Participants With a Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Overall Satisfaction Dimension Mean Score Value of ≥5 and <5 |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants |
| Arm/Group Title | Overall Study Population |
|---|---|
| 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. |
| Measure Participants | 93 |
| Mean Score ≥5 |
54.3
159.7%
|
| Mean Score <5 |
45.7
134.4%
|
| Title | Viral Load (VL) Change After at Least 12 Weeks of Treatment With the Lopinavir/Ritonavir (LPV/r) |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants, per responses to the HIVTSQ Overall Satisfaction Dimension |
| Arm/Group Title | Overall Study Population |
|---|---|
| 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. |
| Measure Participants | 93 |
| Detectable to Undetectable |
51
150%
|
| Undetectable to Undetectable |
16
47.1%
|
| Current Detectable |
25
73.5%
|
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 | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | ||
| 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 |
|
| Parameter Dispersion |
Type: Value: |
|
| 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. | |
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 | ||
| Statistical Test of Hypothesis | p-Value | 0.072 |
| Comments | ||
| 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 |
|
| Parameter Dispersion |
Type: Value: |
|
| 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. | |
| Title | Mean Number of Days on LPV/r QD |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants, per responses to the HIVTSQ Overall Satisfaction Dimension |
| Arm/Group Title | Overall Study Population |
|---|---|
| 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. |
| Measure Participants | 92 |
| Mean (Standard Deviation) [days] |
208.3
(161.2)
|
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 | ||
| Statistical Test of Hypothesis | p-Value | 0.025 |
| Comments | ||
| 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 |
|
| Parameter Dispersion |
Type: Value: |
|
| 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. | |
| Title | Comparison of Mean Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension Scores From QD-KAPITAL and KAPITAL2 Studies |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants with evaluable data. n=the number of participants with data for given dimension. |
| Arm/Group Title | Overall Study Population |
|---|---|
| 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. |
| Measure Participants | 93 |
| Overall Satisfaction (n=92) |
44.4
(7.6)
|
| General/Clinical Satisfaction (n=93) |
25.5
(4.9)
|
| Lifestyle (n=93) |
18.6
(4.1)
|
| Title | Percentage of Participants With Missing Doses During "the Past 4 Days" and "the Last Weekend" in KAPITAL-2 and QD-KAPITAL Studies |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants with evaluable data. |
| Arm/Group Title | Overall Study Population |
|---|---|
| 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. |
| Measure Participants | 94 |
| No Missing Doses During Past 4 days |
90.4
265.9%
|
| ≥1 Missing Doses During Past 4 days |
9.6
28.2%
|
| No Missing Doses During Last Weekend |
90.4
265.9%
|
| ≥1 Missing Doses During Last Weekend |
9.6
28.2%
|
Adverse Events
| Time Frame | Collected at the single study visit, performed after at least 12 weeks of treatment with Kaletra QD | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Overall Study Population | |
| 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 (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Overall Study Population | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/94 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Overall Study Population | ||
| Affected / at Risk (%) | # Events | |
| Total | 13/94 (13.8%) | |
| Gastrointestinal disorders | ||
| Diarrhea | 10/94 (10.6%) | |
| Nausea | 2/94 (2.1%) | |
| Dyspepsia | 1/94 (1.1%) | |
| General disorders | ||
| Burning Sensation | 2/94 (2.1%) | |
| Musculoskeletal and connective tissue disorders | ||
| Musculoskeletal pain | 2/94 (2.1%) | |
| Reproductive system and breast disorders | ||
| Sexual Disorder NOS | 1/94 (1.1%) | |
| Skin and subcutaneous tissue disorders | ||
| Skin Disorders NOS | 1/94 (1.1%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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 |
- P12-752