NCT01083173

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"

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 595 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 2 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• HIV-1 Infection

Timeline

• Start date: 2009-10-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2010-03-09
• Last updated: 2016-02-22
• Results posted: 2016-02-22