Surveillance of Kaletra in Korean Patients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

595 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2014-10-31

Brief Summary

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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.

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Detailed Description

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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

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HIV-1 Infection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with HIV-1 infection

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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No