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

NCT01383005 | Completed Results

• 1 other identifier: P12-752
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 20

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.

Conditions

Human Immunodeficiency Virus Infection

Keywords

Treatment satisfaction; Adherence to treatment

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  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)

  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)

  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

  At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead
• Triaca Magna, SA: collaborator

Study Sites (20)

Site Ref # / Investigator 52274

A Coruña, 15006, Spain

Location

Site Ref # / Investigator 52363

Barakaldo, 48903, Spain

Location

Site Ref # / Investigator 52271

Barcelona, 08035, Spain

Location

Site Ref # / Investigator 52270

Barcelona, 8036, Spain

Location

Site Ref # / Investigator 52362

Cartagena, 30203, Spain

Location

Site Ref # / Investigator 53650

Castellon, 12004, Spain

Location

Site Ref # / Investigator 52273

Ferrol (A Coruna), 15405, Spain

Location

Site Ref # / Investigator 52264

Granada, 18014, Spain

Location

Site Ref # / Investigator 52262

Jaén, 23007, Spain

Location

Site Ref # / Investigator 52263

Jerez de La Frontera (Cadiz), 11407, Spain

Location

Site Ref # / Investigator 52267

L'Hospitalet de Llobregat, 08906, Spain

Location

Site Ref # / Investigator 52345

Madrid, 28007, Spain

Location

Site Ref # / Investigator 52275

Madrid, 28034, Spain

Location

Site Ref # / Investigator 52302

Madrid, 28046, Spain

Location

Site Ref # / Investigator 52343

Madrid, 28880, Spain

Location

Site Ref # / Investigator 52344

Madrid, 28905, Spain

Location

Site Ref # / Investigator 53648

Murcia, 30003, Spain

Location

Site Ref # / Investigator 52268

Reus (Tarragona), 43201, Spain

Location

Site Ref # / Investigator 52272

Valencia, 46009, Spain

Location

Site Ref # / Investigator 52266

Zaragoza, 50009, Spain

Location

Related Links

• Related Info

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Health Behavior; Behavior

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Angel Burgos, PhD

  AbbVie S.L.U.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: June 28, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 6, 2013
• Results First Posted: April 22, 2013

Record last verified: 2013-04

Locations

ES (20)