Treatment Perception of QD (Once a Day) Dosed Kaletra (Tablets)
NCT ID: NCT01383005
Last Updated: 2013-05-06
Study Results
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View full resultsBasic Information
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COMPLETED
97 participants
OBSERVATIONAL
2011-06-30
2011-12-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Triaca Magna, SA
UNKNOWN
AbbVie (prior sponsor, Abbott)
INDUSTRY
Responsible Party
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Principal Investigators
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Angel Burgos, PhD
Role: STUDY_DIRECTOR
AbbVie S.L.U.
Locations
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Site Ref # / Investigator 52274
A Coruña, , Spain
Site Ref # / Investigator 52363
Barakaldo, , Spain
Site Ref # / Investigator 52271
Barcelona, , Spain
Site Ref # / Investigator 52270
Barcelona, , Spain
Site Ref # / Investigator 52362
Cartagena, , Spain
Site Ref # / Investigator 53650
Castellon, , Spain
Site Ref # / Investigator 52273
Ferrol (A Coruna), , Spain
Site Ref # / Investigator 52264
Granada, , Spain
Site Ref # / Investigator 52262
Jaén, , Spain
Site Ref # / Investigator 52263
Jerez de La Frontera (Cadiz), , Spain
Site Ref # / Investigator 52267
L'Hospitalet de Llobregat, , Spain
Site Ref # / Investigator 52345
Madrid, , Spain
Site Ref # / Investigator 52275
Madrid, , Spain
Site Ref # / Investigator 52302
Madrid, , Spain
Site Ref # / Investigator 52343
Madrid, , Spain
Site Ref # / Investigator 52344
Madrid, , Spain
Site Ref # / Investigator 53648
Murcia, , Spain
Site Ref # / Investigator 52268
Reus (Tarragona), , Spain
Site Ref # / Investigator 52272
Valencia, , Spain
Site Ref # / Investigator 52266
Zaragoza, , Spain
Countries
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Related Links
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Related Info
Other Identifiers
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P12-752
Identifier Type: -
Identifier Source: org_study_id
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