Real-life Effectiveness of the Kaletra Adherence Support Assistance (KASA) Program

NCT01662336 | Completed Results

• 1 other identifier: P13-566
• Study Type: observational
• Target: 173
• Locations: 0 countries
• Sites: N/A

Brief Summary

The overall purpose of the study was to describe the real-life adherence, effectiveness and safety of the Kaletra Adherence Support Assistance (KASA) Program in human immunodeficiency virus (HIV)-positive patients who were receiving treatment with lopinavir / ritonavir (LPV/r; Kaletra®) in Canada.

Conditions

Human Immunodeficiency Virus Infection

Keywords

Human Immunodeficiency Virus infection

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Adherent to Treatment at Month 6

  Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12 item tool that measures the patient's confidence to undertake treatment related activities and behaviors including medication regimen, diet and exercise. Each question is answered on a scale from 0 (cannot do at all) to 10 (certain can do). A summative score ranging from 0 to 120 was calculated, with higher scores indicating higher treatment self-efficacy. A participant was considered to have maintained adherence if the change in the ASES summative score at month 6 relative to Baseline was greater than or equal to zero. Participants who discontinued from the study or were lost to follow-up were considered non-adherent.

  Baseline and 6 months

Secondary Outcomes (19)

• Change From Baseline in Adherence Summative Score at Months 6 and 12

  Baseline, Month 6 and Month 12

• Change From Baseline in Adherence Integration Subscale Score at Months 6 and 12

  Baseline, Month 6 and Month 12

• Change From Baseline in Adherence Perseverance Subscale Score at Months 6 and 12

  Baseline, Month 6 and Month 12

• Percentage of Participants Adherent to Treatment at Month 12

  Baseline and 12 months

• Change From Baseline in Health-related Quality of Life General Health Perception Domain Score

  Baseline, Month 6 and Month 12

Study Arms (1)

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.

Drug: Lopinavir / ritonavir; Behavioral: Kaletra Adherence Support Assistance Program

Interventions

Lopinavir / ritonavir DRUG

Prescribed according to the product monograph and physician's discretion.

Also known as: Kaletra®, LPV/r

Lopinavir/Ritonavir + KASA

Kaletra Adherence Support Assistance Program BEHAVIORAL

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.

Also known as: KASA

Lopinavir/Ritonavir + KASA

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

Patients were enrolled from the offices (at clinic or hospital) of primary care physicians across Canada treating HIV-positive patients.

You may qualify if:

• Subject is HIV-positive
• 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.

You may not qualify if:

• Not willing to sign an informed consent.
• 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Related Links

• Related Info

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Lopinavir; lopinavir-ritonavir drug combination

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

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

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

800-633-9110

Study Officials

• Christina Pelizon, MD

  AbbVie Corporation

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2012
• First Posted: August 10, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: January 29, 2018
• Results First Posted: January 29, 2018

Record last verified: 2017-06