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

AbbVie

Status: Completed

Conditions: Human Immunodeficiency Virus Infection

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

Study type: Observational

Funder types: Industry

Identifiers

NCT01662336

P13-566

Details and patient eligibility

About

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.

Full description

The Kaletra Adherence Support Assistance (KASA) Program is a customized support network that has been offered to patients treated with lopinavir / ritonavir (LPV/r; Kaletra®). KASA 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. Patients enrolled in KASA may also have access to various healthcare professionals (dietician, social worker, psychologist, etc.) or may be offered other types of support (transportation, exercise, etc.), which may help improve their quality of life as well as adherence or compliance while taking LPV/r.

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.

Enrollment: 173 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

173 participants in 1 patient group

Lopinavir/Ritonavir + KASA

Description:

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.

Treatment:

Behavioral: Kaletra Adherence Support Assistance Program

Drug: Lopinavir / ritonavir