N/A
Completed N=94
Treatment Perception of QD (Once a Day) Dosed Kaletra (Tablets)
Source: ClinicalTrials.gov NCT01383005 ↗Enrolled (actual)
94
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcomePrimary: Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores for the Overall Study Population — 5.0; 5.4; 4.8; 2.4 units on a scale
Summary
Both twice-a-day (BID) and once-a-day (QD) dosing are approved in Europe for the protease inhibitor lopinavir/ritonavir (LPV/r; Kaletra®).
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores for the Overall Study Population |
5.0; 5.4; 4.8; 2.4; 4.8; 4.2 | — |
| PRIMARY Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ)Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores for the Overall Study Population |
44.4; 25.5; 18.6 | — |
| SECONDARY Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts |
5.0; 5.1; 5.4; 5.5; 4.8; 5.1 | — |
| SECONDARY Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores Comparison Between Cohorts |
43.3; 45.0; 24.4; 26.1; 18.2; 18.9 | — |
| SECONDARY Number of Days Without Medication, Per Simplified Medication Adherence Questionnaire (SMAQ) |
30; 36; 3; 8; 1; 15 | — |
| SECONDARY Adherence Classification of Participants Per Simplified Medication Adherence Questionnaire (SMAQ) |
19; 28; 11; 11; 4; 21 | — |
| SECONDARY Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen |
2; 3; 1; 3; 4; 2 | — |
| SECONDARY Percentage of Participants With a Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Overall Satisfaction Dimension Mean Score Value of ≥5 and <5 |
54.3; 45.7 | — |
| SECONDARY Viral Load (VL) Change After at Least 12 Weeks of Treatment With the Lopinavir/Ritonavir (LPV/r) |
51; 16; 25 | 0.001 sig |
| SECONDARY Mean Number of Days on LPV/r QD |
208.3 | 0.025 sig |
| SECONDARY Comparison of Mean Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension Scores From QD-KAPITAL and KAPITAL2 Studies |
44.4; 25.5; 18.6 | — |
| SECONDARY Percentage of Participants With Missing Doses During "the Past 4 Days" and "the Last Weekend" in KAPITAL-2 and QD-KAPITAL Studies |
90.4; 9.6; 90.4; 9.6 | — |
Eligibility Criteria
Inclusion criteria
- Men or women aged 18 years or older, HIV-infected.
- 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).*
- Patients who were able to complete questionnaires by themselves.
- 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
- Patients who were on LPV/r monotherapy or bi-therapy or on BID dosing at time of study visit.
- Patients who were using another LPV/r formulation different from 200/50 LPV/r mg tablets.
- Patients who were participating in any other clinical trial or postmarketing observational study (PMOS).
- Patients who were unable to read and/or write.
- Patients who were under treatment interruption. Patients who have stopped LPV-therapy for more than 3 months in the 12 months preceding study visit.
Data sourced from ClinicalTrials.gov (NCT01383005). 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. Informational only — not medical advice.