Clinical trial NCT01383005: Treatment Perception of QD (Once a Day) Dosed Kaletra (Tablets)
Official title: Treatment Perception of QD Dosed Kaletra (Tablets) Based Treatment in HIV Infected Patients. Observational Cross-Sectional Study (QD-KAPITAL)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus Infection
Keywords: Treatment satisfaction
Adherence to treatment
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Triaca Magna, SA
First posted: 2011-06-28
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-infected patients regularly visiting Spanish hospital/clinic physicians and treated with lopinavir/ritonavir once-a-day regimens.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores for the Overall Study Population
timeFrame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD
measure: Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ)Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores for the Overall Study Population
timeFrame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD
Secondary outcomes:
measure: Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts
timeFrame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD
measure: Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores Comparison Between Cohorts
timeFrame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD
measure: Number of Days Without Medication, Per Simplified Medication Adherence Questionnaire (SMAQ)
timeFrame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD
measure: Adherence Classification of Participants Per Simplified Medication Adherence Questionnaire (SMAQ)
timeFrame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD
measure: Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen
timeFrame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD
measure: Percentage of Participants With a Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Overall Satisfaction Dimension Mean Score Value of ≥5 and <5
timeFrame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD
measure: Viral Load (VL) Change After at Least 12 Weeks of Treatment With the Lopinavir/Ritonavir (LPV/r)
timeFrame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD
measure: Mean Number of Days on LPV/r QD
timeFrame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD
measure: Comparison of Mean Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension Scores From QD-KAPITAL and KAPITAL2 Studies
timeFrame: at the single study visit, performed after at least 12 weeks of treatment with Kaletra
measure: Percentage of Participants With Missing Doses During "the Past 4 Days" and "the Last Weekend" in KAPITAL-2 and QD-KAPITAL Studies
timeFrame: at the single study visit, performed after at least 12 weeks of treatment with Kaletra
Other outcomes:
Locations:
city: A Coruna
country: Spain
facility: Site Ref # / Investigator 52274
city: Barakaldo
country: Spain
facility: Site Ref # / Investigator 52363
city: Barcelona
country: Spain
facility: Site Ref # / Investigator 52271
city: Barcelona
country: Spain
facility: Site Ref # / Investigator 52270
city: Cartagena
country: Spain
facility: Site Ref # / Investigator 52362
city: Castellon de la Plana
country: Spain
facility: Site Ref # / Investigator 53650
city: Ferrol (A Coruna)
country: Spain
facility: Site Ref # / Investigator 52273
city: Granada
country: Spain
facility: Site Ref # / Investigator 52264
city: Hospitalet de Llobregat
country: Spain
facility: Site Ref # / Investigator 52267
city: Jaen
country: Spain
facility: Site Ref # / Investigator 52262
city: Jerez de la Frontera (Cadiz)
country: Spain
facility: Site Ref # / Investigator 52263
city: Madrid
country: Spain
facility: Site Ref # / Investigator 52345
city: Madrid
country: Spain
facility: Site Ref # / Investigator 52275
city: Madrid
country: Spain
facility: Site Ref # / Investigator 52302
city: Madrid
country: Spain
facility: Site Ref # / Investigator 52343
city: Madrid
country: Spain
facility: Site Ref # / Investigator 52344
city: Murcia
country: Spain
facility: Site Ref # / Investigator 53648
city: Reus (Tarragona)
country: Spain
facility: Site Ref # / Investigator 52268
city: Valencia
country: Spain
facility: Site Ref # / Investigator 52272
city: Zaragoza
country: Spain
facility: Site Ref # / Investigator 52266
Study officials:
affiliation: AbbVie S.L.U.
name: Angel Burgos, PhD
role: STUDY_DIRECTOR
References: