Surveillance of Kaletra in Korean Patients

Post-Marketing Surveillance of Safety and Efficacy of Kaletra® Tablet in Korean Patients Under the "New Drug Re-Examination"

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.

Participants were observed for up to 48 weeks following the first dose of Kaletra. A follow-up visit took place 1-2 weeks after treatment initiation, and subsequent visits occurred at the discretion of the investigators, typically occurring every 3 months. Clinical/immunological/virological/laboratory status, Kaletra-containing regimen/concomitant medication information, and adverse event information were obtained at follow-up visits.

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