Surveillance of Kaletra in Korean Patients

AbbVie

Status: Completed

Conditions: HIV-1 Infection

Study type: Observational

Funder types: Industry

Identifiers

NCT01083173

P11-068

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 595 patients

Sex: All

Ages: 2 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

595 participants in 1 patient group

Participants with HIV-1 infection

Description:

Participants treated with Kaletra (lopinavir/ritonavir 200 mg/50 mg and 100 mg/25 mg) tablet