Human Immunodeficiency Virus Infection
Conditions
Keywords
Treatment satisfaction, Adherence to treatment
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.
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.
Interventions
None listed
Sponsors
Triaca Magna, SA
AbbVie (prior sponsor, Abbott)
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Men or women aged 18 years or older, HIV-infected. 2. 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).\* 3. Patients who were able to complete questionnaires by themselves. 4. 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
1. Patients who were on LPV/r monotherapy or bi-therapy or on BID dosing at time of study visit. 2. Patients who were using another LPV/r formulation different from 200/50 LPV/r mg tablets. 3. Patients who were participating in any other clinical trial or postmarketing observational study (PMOS). 4. Patients who were unable to read and/or write. 5. Patients who were under treatment interruption. Patients who have stopped LPV-therapy for more than 3 months in the 12 months preceding study visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Spain
Participant flow
Pre-assignment details
97 participants were enrolled; 3 participants who did not meet the inclusion criteria for treatment duration were excluded.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 34 |
| 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. | 60 |
| Total | 94 |
Baseline characteristics
| Characteristic | Kaletra (LPV/r) QD as First Kaletra Treatment | Kaletra (LPV/r) QD From Kaletra BID | Total |
|---|---|---|---|
| Age Continuous | 36.2 years STANDARD_DEVIATION 9.4 | 39.9 years STANDARD_DEVIATION 8.8 | 38.6 years STANDARD_DEVIATION 9.2 |
| Sex: Female, Male Female | 9 Participants | 21 Participants | 30 Participants |
| Sex: Female, Male Male | 25 Participants | 39 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 13 / 94 |
| serious Total, serious adverse events | 0 / 94 |
Outcome results
Primary
Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ)Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores for the Overall Study Population
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
Population: All participants with complete data. n=number of participants with complete data for given HIVTSQ item.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Population | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ)Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores for the Overall Study Population | Score for Overall Satisfaction (n=92) | 44.4 units on a scale | Standard Deviation 7.6 |
| Overall Study Population | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ)Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores for the Overall Study Population | Score for General/Clinical Satisfaction (n=93) | 25.5 units on a scale | Standard Deviation 4.9 |
| Overall Study Population | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ)Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores for the Overall Study Population | Score of Lifestyle (n=93) | 18.6 units on a scale | Standard Deviation 4.1 |
Primary
Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores for the Overall Study Population
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
Population: All participants with complete data. n=number of participants with complete data for given HIVTSQ item.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Population | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores for the Overall Study Population | Item 5: Convenient (n=94) | 4.8 units on a scale | Standard Deviation 1.4 |
| Overall Study Population | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores for the Overall Study Population | Item 6: Flexible (n=94) | 4.2 units on a scale | Standard Deviation 1.9 |
| Overall Study Population | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores for the Overall Study Population | Item 1: Satisfied (n=93) | 5.0 units on a scale | Standard Deviation 1.2 |
| Overall Study Population | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores for the Overall Study Population | Item 2: HIV Control (n=93) | 5.4 units on a scale | Standard Deviation 1 |
| Overall Study Population | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores for the Overall Study Population | Item 3: Adverse Effects (n=93) | 4.8 units on a scale | Standard Deviation 1.3 |
| Overall Study Population | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores for the Overall Study Population | Item 4: Demanding (n=94) | 2.4 units on a scale | Standard Deviation 2.3 |
| Overall Study Population | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores for the Overall Study Population | Item 7: Knowledge (n=93) | 4.6 units on a scale | Standard Deviation 1.4 |
| Overall Study Population | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores for the Overall Study Population | Item 8: Life Habits (n=94) | 4.9 units on a scale | Standard Deviation 1.3 |
| Overall Study Population | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores for the Overall Study Population | Item 9: Would Recommend (n=94) | 5.1 units on a scale | Standard Deviation 1.2 |
| Overall Study Population | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores for the Overall Study Population | Item 10: Willing to Continue (n=94) | 5.0 units on a scale | Standard Deviation 1.5 |
Secondary
Adherence Classification of Participants Per Simplified Medication Adherence Questionnaire (SMAQ)
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
Population: All participants with complete data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Population | Adherence Classification of Participants Per Simplified Medication Adherence Questionnaire (SMAQ) | Perfect Adherence | 19 participants |
| Overall Study Population | Adherence Classification of Participants Per Simplified Medication Adherence Questionnaire (SMAQ) | Adequate Adherence | 11 participants |
| Overall Study Population | Adherence Classification of Participants Per Simplified Medication Adherence Questionnaire (SMAQ) | Poor Adherence | 4 participants |
| Kaletra (LPV/r) QD From Kaletra BID | Adherence Classification of Participants Per Simplified Medication Adherence Questionnaire (SMAQ) | Perfect Adherence | 28 participants |
| Kaletra (LPV/r) QD From Kaletra BID | Adherence Classification of Participants Per Simplified Medication Adherence Questionnaire (SMAQ) | Adequate Adherence | 11 participants |
| Kaletra (LPV/r) QD From Kaletra BID | Adherence Classification of Participants Per Simplified Medication Adherence Questionnaire (SMAQ) | Poor Adherence | 21 participants |
Secondary
Comparison of Mean Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension Scores From QD-KAPITAL and KAPITAL2 Studies
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
Population: All participants with evaluable data. n=the number of participants with data for given dimension.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Population | Comparison of Mean Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension Scores From QD-KAPITAL and KAPITAL2 Studies | Overall Satisfaction (n=92) | 44.4 units on a scale | Standard Deviation 7.6 |
| Overall Study Population | Comparison of Mean Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension Scores From QD-KAPITAL and KAPITAL2 Studies | General/Clinical Satisfaction (n=93) | 25.5 units on a scale | Standard Deviation 4.9 |
| Overall Study Population | Comparison of Mean Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension Scores From QD-KAPITAL and KAPITAL2 Studies | Lifestyle (n=93) | 18.6 units on a scale | Standard Deviation 4.1 |
Secondary
Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores Comparison Between Cohorts
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
Population: All participants with complete data. n=number of participants with complete data for given HIVTSQ item.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Population | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores Comparison Between Cohorts | Score for Overall Satisfaction (n=32, 60) | 43.3 units on a scale | Standard Deviation 7.9 |
| Overall Study Population | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores Comparison Between Cohorts | Score for General/Clinical Satisfaction (n=33, 60) | 24.4 units on a scale | Standard Deviation 5.7 |
| Overall Study Population | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores Comparison Between Cohorts | Score for Lifestyle (n=33, 60) | 18.2 units on a scale | Standard Deviation 4.4 |
| Kaletra (LPV/r) QD From Kaletra BID | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores Comparison Between Cohorts | Score for Overall Satisfaction (n=32, 60) | 45.0 units on a scale | Standard Deviation 7.5 |
| Kaletra (LPV/r) QD From Kaletra BID | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores Comparison Between Cohorts | Score for General/Clinical Satisfaction (n=33, 60) | 26.1 units on a scale | Standard Deviation 4.4 |
| Kaletra (LPV/r) QD From Kaletra BID | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores Comparison Between Cohorts | Score for Lifestyle (n=33, 60) | 18.9 units on a scale | Standard Deviation 3.9 |
Secondary
Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts
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
Population: All participants with complete data. n=number of participants with complete data for given HIVTSQ item.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Population | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts | Item 3: Adverse Effects (n=33, 60) | 4.8 units on a scale | Standard Deviation 24 |
| Overall Study Population | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts | Item 6: Flexible (n=34, 60) | 4.2 units on a scale | Standard Deviation 32.5 |
| Overall Study Population | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts | Item 2: HIV Control (n=33, 60) | 5.4 units on a scale | Standard Deviation 18.1 |
| Overall Study Population | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts | Item 7: Knowledge (n=33, 60) | 4.6 units on a scale | Standard Deviation 23.6 |
| Overall Study Population | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts | Item 4: Demanding (n=34, 60) | 2.4 units on a scale | Standard Deviation 38.4 |
| Overall Study Population | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts | Item 8: Life Habits (n=34, 60) | 4.9 units on a scale | Standard Deviation 22.9 |
| Overall Study Population | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts | Item 1: Satisfied (n=33, 60) | 5.0 units on a scale | Standard Deviation 27.7 |
| Overall Study Population | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts | Item 9: Would Recommend (n=34, 60) | 5.1 units on a scale | Standard Deviation 21.4 |
| Overall Study Population | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts | Item 5: Convenient (n=34, 60) | 4.8 units on a scale | Standard Deviation 24 |
| Overall Study Population | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts | Item 10: Willing to Continue (n=34, 60) | 5.0 units on a scale | Standard Deviation 26.4 |
| Kaletra (LPV/r) QD From Kaletra BID | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts | Item 10: Willing to Continue (n=34, 60) | 5.1 units on a scale | Standard Deviation 23.5 |
| Kaletra (LPV/r) QD From Kaletra BID | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts | Item 1: Satisfied (n=33, 60) | 5.1 units on a scale | Standard Deviation 18.3 |
| Kaletra (LPV/r) QD From Kaletra BID | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts | Item 2: HIV Control (n=33, 60) | 5.5 units on a scale | Standard Deviation 16.1 |
| Kaletra (LPV/r) QD From Kaletra BID | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts | Item 3: Adverse Effects (n=33, 60) | 5.1 units on a scale | Standard Deviation 19.6 |
| Kaletra (LPV/r) QD From Kaletra BID | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts | Item 4: Demanding (n=34, 60) | 2.5 units on a scale | Standard Deviation 38.3 |
| Kaletra (LPV/r) QD From Kaletra BID | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts | Item 5: Convenient (n=34, 60) | 5.0 units on a scale | Standard Deviation 21.6 |
| Kaletra (LPV/r) QD From Kaletra BID | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts | Item 6: Flexible (n=34, 60) | 4.3 units on a scale | Standard Deviation 30.6 |
| Kaletra (LPV/r) QD From Kaletra BID | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts | Item 7: Knowledge (n=33, 60) | 4.7 units on a scale | Standard Deviation 22.1 |
| Kaletra (LPV/r) QD From Kaletra BID | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts | Item 8: Life Habits (n=34, 60) | 5.0 units on a scale | Standard Deviation 21.6 |
| Kaletra (LPV/r) QD From Kaletra BID | Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts | Item 9: Would Recommend (n=34, 60) | 5.3 units on a scale | Standard Deviation 19.7 |
Secondary
Mean Number of Days on LPV/r 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).
Time frame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD
Population: All participants, per responses to the HIVTSQ Overall Satisfaction Dimension
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Study Population | Mean Number of Days on LPV/r QD | 208.3 days | Standard Deviation 161.2 |
Comparison: 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.p-value: 0.02595% CI: [0.992, 0.999]Regression, Logistic
Secondary
Number of Days Without Medication, Per Simplified Medication Adherence Questionnaire (SMAQ)
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
Population: All participants with complete data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Population | Number of Days Without Medication, Per Simplified Medication Adherence Questionnaire (SMAQ) | None | 30 participants |
| Overall Study Population | Number of Days Without Medication, Per Simplified Medication Adherence Questionnaire (SMAQ) | One Day | 3 participants |
| Overall Study Population | Number of Days Without Medication, Per Simplified Medication Adherence Questionnaire (SMAQ) | More than One Day | 1 participants |
| Kaletra (LPV/r) QD From Kaletra BID | Number of Days Without Medication, Per Simplified Medication Adherence Questionnaire (SMAQ) | None | 36 participants |
| Kaletra (LPV/r) QD From Kaletra BID | Number of Days Without Medication, Per Simplified Medication Adherence Questionnaire (SMAQ) | One Day | 8 participants |
| Kaletra (LPV/r) QD From Kaletra BID | Number of Days Without Medication, Per Simplified Medication Adherence Questionnaire (SMAQ) | More than One Day | 15 participants |
Secondary
Percentage of Participants With a Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Overall Satisfaction Dimension Mean Score Value of ≥5 and <5
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
Population: All participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Population | Percentage of Participants With a Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Overall Satisfaction Dimension Mean Score Value of ≥5 and <5 | Mean Score ≥5 | 54.3 percentage of participants |
| Overall Study Population | Percentage of Participants With a Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Overall Satisfaction Dimension Mean Score Value of ≥5 and <5 | Mean Score <5 | 45.7 percentage of participants |
Secondary
Percentage of Participants With Missing Doses During the Past 4 Days and the Last Weekend in KAPITAL-2 and QD-KAPITAL Studies
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
Population: All participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Population | Percentage of Participants With Missing Doses During the Past 4 Days and the Last Weekend in KAPITAL-2 and QD-KAPITAL Studies | ≥1 Missing Doses During Last Weekend | 9.6 percentage of participants |
| Overall Study Population | Percentage of Participants With Missing Doses During the Past 4 Days and the Last Weekend in KAPITAL-2 and QD-KAPITAL Studies | No Missing Doses During Past 4 days | 90.4 percentage of participants |
| Overall Study Population | Percentage of Participants With Missing Doses During the Past 4 Days and the Last Weekend in KAPITAL-2 and QD-KAPITAL Studies | ≥1 Missing Doses During Past 4 days | 9.6 percentage of participants |
| Overall Study Population | Percentage of Participants With Missing Doses During the Past 4 Days and the Last Weekend in KAPITAL-2 and QD-KAPITAL Studies | No Missing Doses During Last Weekend | 90.4 percentage of participants |
Secondary
Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen
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
Population: All participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Population | Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen | Simp + Adherence | 12 participants |
| Overall Study Population | Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen | Pref + Adjust to ARV | 1 participants |
| Overall Study Population | Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen | Adherence | 6 participants |
| Overall Study Population | Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen | Simp+ Pref + Adjust to ARV + Adherence + Lifestyle | 2 participants |
| Overall Study Population | Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen | Simp + Pref + Adjust to ARV + Adherence | 3 participants |
| Overall Study Population | Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen | Simp + Pref + Adjust to ARV + Lifestyle | 1 participants |
| Overall Study Population | Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen | Simp+ Pref + Adherence + Lifestyle | 3 participants |
| Overall Study Population | Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen | Simp + Pref + Adherence | 4 participants |
| Overall Study Population | Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen | Simp + Pref + Lifestyle | 2 participants |
| Overall Study Population | Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen | Simp + Pref | 3 participants |
| Overall Study Population | Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen | Simp + Adjust to ARV + Adherence + Lifestyle | 2 participants |
| Overall Study Population | Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen | Simp + Adjust to ARV + Adherence | 5 participants |
| Overall Study Population | Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen | Simp + Adjust to ARV + Lifestyle | 1 participants |
| Overall Study Population | Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen | Simp + Adjust to ARV | 1 participants |
| Overall Study Population | Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen | Simp + Adherence + Lifestyle + Tolerability | 1 participants |
| Overall Study Population | Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen | Simp + Adherence + Lifestyle | 6 participants |
| Overall Study Population | Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen | Simp + Lifestyle | 1 participants |
| Overall Study Population | Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen | Simp + Tolerability | 1 participants |
| Overall Study Population | Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen | Simp | 18 participants |
| Overall Study Population | Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen | Pref + Adjust to ARV + Adherence + Lifestyle | 1 participants |
| Overall Study Population | Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen | Pref + Adherence + Lifestyle | 1 participants |
| Overall Study Population | Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen | Pref + Adherence | 1 participants |
| Overall Study Population | Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen | Pref | 4 participants |
| Overall Study Population | Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen | Adjust to ARV + Adherence + Lifestyle | 1 participants |
| Overall Study Population | Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen | Adjust to ARV + Lifestyle | 3 participants |
| Overall Study Population | Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen | Adjust to ARV | 1 participants |
| Overall Study Population | Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen | Adherence + Lifestyle + Tolerability | 1 participants |
| Overall Study Population | Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen | Adherence + Lifestyle | 5 participants |
| Overall Study Population | Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen | Lifestyle | 3 participants |
Secondary
Viral Load (VL) Change After at Least 12 Weeks of Treatment With the Lopinavir/Ritonavir (LPV/r)
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
Population: All participants, per responses to the HIVTSQ Overall Satisfaction Dimension
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Population | Viral Load (VL) Change After at Least 12 Weeks of Treatment With the Lopinavir/Ritonavir (LPV/r) | Detectable to Undetectable | 51 participants |
| Overall Study Population | Viral Load (VL) Change After at Least 12 Weeks of Treatment With the Lopinavir/Ritonavir (LPV/r) | Undetectable to Undetectable | 16 participants |
| Overall Study Population | Viral Load (VL) Change After at Least 12 Weeks of Treatment With the Lopinavir/Ritonavir (LPV/r) | Current Detectable | 25 participants |
Comparison: 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.p-value: 0.00195% CI: [0.052, 0.494]Regression, Logistic
Comparison: 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.p-value: 0.07295% CI: [0.07, 1.118]Regression, Logistic