Real-life Effectiveness of the Kaletra Adherence Support Assistance (KASA) Program
NCT ID: NCT01662336
Last Updated: 2018-01-29
Study Results
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View full resultsBasic Information
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COMPLETED
173 participants
OBSERVATIONAL
2012-06-30
2016-06-30
Brief Summary
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Detailed Description
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This was a 12-month, multi-center, Canadian Post Marketing Observational Study utilizing a prospective single cohort design. All treatments including participation in the KASA program were according to the decision of the treating physician and the patients and were not affected in any way by their decision to participate in the study. Follow-up was for 12 months at an interval of every six months.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Lopinavir/Ritonavir + KASA
Patients were treated according to the standard of care provided by their respective study sites. Treatments with LPV/r and participation in the KASA program were according to the decision of the treating physician and the participant, and were not affected in any way by their decision to participate in the study.
Lopinavir / ritonavir
Prescribed according to the product monograph and physician's discretion.
Kaletra Adherence Support Assistance Program
A customized support network for patients treated with lopinavir / ritonavir that offers individual counseling with an HIV experienced nurse who assists patients with various aspects of their therapy including life-style changes, emotional stress, and adverse events, and may provide access to various healthcare professionals or may offer other types of support such as transportation, exercise, etc.
Interventions
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Lopinavir / ritonavir
Prescribed according to the product monograph and physician's discretion.
Kaletra Adherence Support Assistance Program
A customized support network for patients treated with lopinavir / ritonavir that offers individual counseling with an HIV experienced nurse who assists patients with various aspects of their therapy including life-style changes, emotional stress, and adverse events, and may provide access to various healthcare professionals or may offer other types of support such as transportation, exercise, etc.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* On treatment with LPV/r or currently initiated on treatment with LPV/r.
* Has provided written informed consent allowing the use of their data for the study and providing permission for contact by the study personnel.
* Willing to be enrolled in the Kaletra Adherence Support Assistance (KASA) program.
* Prescribed LPV/r as part of his/her treatment by the treating physician.
Exclusion Criteria
* In the opinion of the treating physician is unlikely to be available for the 12-month follow-up duration of the study.
* Is currently participating in a clinical trial of an investigational product.
* Not willing to participate in the KASA program.
18 Years
ALL
No
Sponsors
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AbbVie (prior sponsor, Abbott)
INDUSTRY
Responsible Party
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Principal Investigators
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Christina Pelizon, MD
Role: STUDY_DIRECTOR
AbbVie Corporation
Related Links
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Related Info
Other Identifiers
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P13-566
Identifier Type: -
Identifier Source: org_study_id
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