Human Immunodeficiency Virus InfectionQD-KapitalNCT01383005
Treatment Perception of QD (Once a Day) Dosed Kaletra (Tablets)
An observational study of Human Immunodeficiency Virus Infection, run by AbbVie (prior sponsor, Abbott) at 20 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus Infection
- How many people
- 97 participants
- Where
- 20 sitesSpain
- Study dates
- Jun 2011to Dec 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV-infected patients regularly visiting Spanish hospital/clinic physicians and treated with lopinavir/ritonavir once-a-day regimens.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Spain20 sites
Site Ref # / Investigator 52274
A Coruña, 15006
Site Ref # / Investigator 52363
Barakaldo, 48903
Site Ref # / Investigator 52271
Barcelona, 08035
Site Ref # / Investigator 52270
Barcelona, 8036
Site Ref # / Investigator 52362
Cartagena, 30203
Site Ref # / Investigator 53650
Castellon, 12004
Site Ref # / Investigator 52273
Ferrol (A Coruna), 15405
Site Ref # / Investigator 52264
Granada, 18014
Site Ref # / Investigator 52262
Jaén, 23007
Site Ref # / Investigator 52263
Jerez de La Frontera (Cadiz), 11407
Site Ref # / Investigator 52267
L'Hospitalet de Llobregat, 08906
Site Ref # / Investigator 52345
Madrid, 28007
Site Ref # / Investigator 52275
Madrid, 28034
Site Ref # / Investigator 52302
Madrid, 28046
Site Ref # / Investigator 52343
Madrid, 28880
Site Ref # / Investigator 52344
Madrid, 28905
Site Ref # / Investigator 53648
Murcia, 30003
Site Ref # / Investigator 52268
Reus (Tarragona), 43201
Site Ref # / Investigator 52272
Valencia, 46009
Site Ref # / Investigator 52266
Zaragoza, 50009
About this study
Official title: Treatment Perception of QD Dosed Kaletra (Tablets) Based Treatment in HIV Infected Patients. Observational Cross-Sectional Study (QD-KAPITAL)
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.
Read the 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.
- Conditions
- Human Immunodeficiency Virus Infection
- Keywords
- Treatment satisfaction, Adherence to treatment
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD
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.
Measured: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD
Secondary outcomes (10)
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.
Measured: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD
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.
Measured: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD
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.)
Measured: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD
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.
Measured: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD
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.
Measured: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD
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.
Measured: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD
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).
Measured: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD
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).
Measured: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD
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.
Measured: at the single study visit, performed after at least 12 weeks of treatment with Kaletra
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.
Measured: at the single study visit, performed after at least 12 weeks of treatment with Kaletra
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Human Immunodeficiency Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Triaca Magna, SA
- Responsible party
- Sponsor
- Investigators
- Angel Burgos, PhD, Study director, AbbVie S.L.U.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01383005
- Sponsor's protocol ID
- P12-752
- Acronym
- QD-Kapital
- Status last verified
- Apr 2013
- First submitted
- 31 May 2011
- Last updated
- 6 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Perception of QD Dosed Kaletra (Tablets) Based Treatment in HIV Infected Patients. Observational Cross-Sectional Study (QD-KAPITAL)
- ClinicalTrials.gov ID
- NCT01383005
- Acronym / sponsor ID
- QD-Kapital / P12-752
- Conditions
- Human Immunodeficiency Virus Infection
- Keywords
- Treatment satisfaction, Adherence to treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Collaborators
- Triaca Magna, SA
- Study start
- Jun 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 28 Jun 2011 (estimated)
- Results
- Posted 22 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-infected patients regularly visiting Spanish hospital/clinic physicians and treated with lopinavir/ritonavir once-a-day regimens.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores for the Overall Study Population
Time frame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD
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
Time frame: 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.
10 secondary outcomes
Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts
Time frame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD
Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores Comparison Between Cohorts
Time frame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD
Number of Days Without Medication, Per Simplified Medication Adherence Questionnaire (SMAQ)
Time frame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD
Adherence Classification of Participants Per Simplified Medication Adherence Questionnaire (SMAQ)
Time frame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD
Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen
Time frame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD
Percentage of Participants With a Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Overall Satisfaction Dimension Mean Score Value of ≥5 and <5
Time frame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD
Viral Load (VL) Change After at Least 12 Weeks of Treatment With the Lopinavir/Ritonavir (LPV/r)
Time frame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD
Mean Number of Days on LPV/r QD
Time frame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD
Comparison of Mean Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension Scores From QD-KAPITAL and KAPITAL2 Studies
Time frame: at the single study visit, performed after at least 12 weeks of treatment with Kaletra
Percentage of Participants With Missing Doses During "the Past 4 Days" and "the Last Weekend" in KAPITAL-2 and QD-KAPITAL Studies
Time frame: at the single study visit, performed after at least 12 weeks of treatment with Kaletra
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
Related trials for Human Immunodeficiency Virus Infection
Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
Enrolling by invitation
Effect of Omega-3 Supplementation on Pregnant Outcomes and Inflammation Markers of Women Infected With HIV Using Antiretroviral Therapy
Pregnant HIV Positive Women
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angel Burgos, PhD study director
AbbVie S.L.U.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus Infection, run by AbbVie (prior sponsor, Abbott) at 20 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores for the Overall Study Population (time frame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2013.