N/A
Completed N=595
Surveillance of Kaletra in Korean Patients
Source: ClinicalTrials.gov NCT01083173 ↗Enrolled (actual)
595
Serious AEs
8.5%
Results posted
Feb 2016
Primary outcomePrimary: Number of Participants With Adverse Events — 363; 285 participants
Summary
This single-arm, multi-center, Post-Marketing Surveillance study of Kaletra (lopinavir/ritonavir) was conducted in accordance with the approved Korean product labeling in participants 2 years of age and older with human immunodeficiency virus type 1 (HIV-1) infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
363; 285 | — |
| PRIMARY Number of Participants Who Interrupted or Discontinued Kaletra Treatment |
120; 43 | — |
| PRIMARY Percentage of Participants With Viral Load Below 400 Copies/mL |
92.4 | — |
| PRIMARY Percentage of Participants With Viral Load Below 50 Copies/mL |
68.6 | — |
| SECONDARY Change From Baseline in Viral Load |
— | — |
| SECONDARY Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Counts |
145.47; 170.47 | < 0.0001 sig |
| SECONDARY Percentage of Participants With Confirmed Viral Resistance |
0.51; 1.96 | — |
| SECONDARY Mean Time to Treatment Failure |
399.97; 410.8 | — |
Eligibility Criteria
Inclusion Criteria
- Patients 2 years of age and above with HIV-1 infection
- Patients who were prescribed Kaletra treatment as per investigator's medical judgment
- Patients who gave verbal or written authorization to use their personal and health data
- Patients who started Kaletra treatment after study agreement was in place
Exclusion Criteria
- Patients with known hypersensitivity to lopinavir, ritonavir or any excipients of the Kaletra tablet
- Patients who were being treated or will be treated with drugs that are contraindicated with Kaletra
- Patients who have been treated with Kaletra
- Patients participating in other clinical trials
Data sourced from ClinicalTrials.gov (NCT01083173). 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.