Surveillance of Kaletra in Korean Patients

• Adverse events [ Time Frame: About one month after the initiation of Kaletra®-containing regimen, then at an average interval of 3 months ] [ Designated as safety issue: Yes ]
• Number of subjects who interrupt or discontinue Kaletra-containing regimen [ Time Frame: Week 24 & 48 ] [ Designated as safety issue: Yes ]
• Proportion of subjects with viral load below 400 copies/mL [ Time Frame: Week 24 & 48 ] [ Designated as safety issue: No ]

• Change from baseline in viral load [ Time Frame: Week 24 & 48 ] [ Designated as safety issue: No ]
• Change from baseline in cluster of differentiation 4 (CD4) counts [ Time Frame: Week 24 & 48 ] [ Designated as safety issue: No ]
• Subjects with confirmed resistance [ Time Frame: Week 24 and 48 ] [ Designated as safety issue: No ]
• Time to treatment failure [ Time Frame: Week 24 & 48 ] [ Designated as safety issue: No ]

• Change from baseline in viral load [ Time Frame: Week 24 & 48 ] [ Designated as safety issue: No ]
• Change from baseline in CD4 counts [ Time Frame: Week 24 & 48 ] [ Designated as safety issue: No ]
• Subjects with confirmed resistance [ Time Frame: Week 24 and 48 ] [ Designated as safety issue: No ]
• Time to treatment failure [ Time Frame: Week 24 & 48 ] [ Designated as safety issue: No ]

About 600 patients who are prescribed Kaletra® treatment will be registered in the study and be treated with Kaletra® in accordance with the approved Korean product labeling and observed for up to 48 weeks following the first dose of Kaletra® tablet. Baseline data will be obtained at inclusion including demographics, Human Immunodeficiency Virus-1 diagnosis history, clinical/immunological.virological/laboratory status, other prior and concomitant disease history, prior anti-retroviral therapy history, Kaletra-containing regimen information and concomitant medication information. At routine follow-up visits which will occur according to usual medical practice, clinical/immunological/virological/laboratory status, Kaletra-containing regimen information, concomitant medication information and adverse events information will be obtained.

general hospitals

Inclusion Criteria:

• Adult patients with HIV-1 infection
• Patients who are prescribed Kaletra® treatment as investigator's medical judgment
• Patients who gave verbal or written authorization to use their personal and health data
• Patients starting Kaletra® treatment after study agreement is in place

Exclusion Criteria:

• Patients with known hypersensitivity to lopinavir, ritonavir or any excipients of Kaletra® tablet
• Patients who are 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 trial