N/A
N=173
Real-life Effectiveness of the Kaletra Adherence Support Assistance (KASA) Program
Human Immunodeficiency Virus Infection
Bottom Line
View on ClinicalTrials.gov: NCT01662336 ↗Enrolled (actual)
173
Serious AEs
1.7%
Results posted
Jan 2018
Primary outcome: Primary: Percentage of Participants Adherent to Treatment at Month 6 — 43.3 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Lopinavir / ritonavir (Drug); Kaletra Adherence Support Assistance Program (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Adherent to Treatment at Month 6 |
43.3 | — |
| SECONDARY Change From Baseline in Adherence Summative Score at Months 6 and 12 |
-1.2; -5.1 | — |
| SECONDARY Change From Baseline in Adherence Integration Subscale Score at Months 6 and 12 |
-0.7; -3.6 | — |
| SECONDARY Change From Baseline in Adherence Perseverance Subscale Score at Months 6 and 12 |
-0.1; -1.0 | — |
| SECONDARY Percentage of Participants Adherent to Treatment at Month 12 |
30.2 | — |
| SECONDARY Change From Baseline in Health-related Quality of Life General Health Perception Domain Score |
-1.0; 1.5 | — |
| SECONDARY Change From Baseline in Health-related Quality of Life Physical Functioning Domain Score |
0.0; 0.1 | — |
| SECONDARY Change From Baseline in Health-related Quality of Life Role Functioning Domain Score |
-0.4; 0.8 | — |
| SECONDARY Change From Baseline in Health-related Quality of Life Social Functioning Domain Score |
0.4; 2.9 | — |
| SECONDARY Change From Baseline in Health-related Quality of Life Cognitive Functioning Domain Score |
1.2; 4.7 | — |
| SECONDARY Change From Baseline in Health-related Quality of Life Pain Domain Score |
-0.3; -1.0 | — |
| SECONDARY Change From Baseline in Health-related Quality of Life Mental Health Domain Score |
-3.0; -1.4 | — |
| SECONDARY Change From Baseline in Health-related Quality of Life Energy/ Fatigue Domain Score |
-2.4; -0.1 | — |
| SECONDARY Change From Baseline in Patient Perception of Stress |
-0.3; -0.8 | — |
| SECONDARY Change From Baseline in Psychological Well-being |
1.7; 1.0 | — |
| SECONDARY Change From Baseline in Coping Self-Efficacy |
2.4; 8.1 | — |
| SECONDARY Health Resource Utilization |
8.1; 8.5; 5.5; 3.5; 2.8; 3.7 | — |
| SECONDARY Viral Load at Each Visit |
111.3; 55.7; 47.2 | — |
| SECONDARY Cluster of Differentiation 4 (CD4) Positive Cell Counts at Each Visit |
547.0; 620.8; 620.2 | — |
| SECONDARY Healthcare Provider Satisfaction |
74.1; 73.3; 65.6; 62.7; 74.7; 70.0 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01662336). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.