Surveillance of Kaletra in Korean Patients

Study Overview
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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.

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.

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

Conditions
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HIV-1 Infection

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with HIV-1 infection<br>Participants treated with Kaletra (lopinavir/ritonavir 200 mg/50 mg and 100 mg/25 mg) tablet | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | Adverse events were recorded during the 48-week surveillance period and until 30 days following the last dose. | From the start of treatment until 30 days after the last dose, up to 52 weeks | 
| Number of Participants Who Interrupted or Discontinued Kaletra Treatment | At 24 and 48 weeks after initiation of Kaletra treatment or upon permanent discontinuation of Kaletra treatment, the investigator documented Kaletra status (on-going, permanently discontinued, lost to follow-up, etc). | Weeks 24 and 48 after initiation of Kaletra treatment or upon permanent discontinuation of Kaletra treatment | 
| Percentage of Participants With Viral Load Below 400 Copies/mL | Blood samples were obtained from participants 24 weeks after the start of Kaletra treatment, and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels. | Week 24 | 
| Percentage of Participants With Viral Load Below 50 Copies/mL | Blood samples were obtained from participants 48 weeks after the start of Kaletra treatment, and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels. | Week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Viral Load | This variable, change from baseline in viral load, was not included in the final protocol. Therefore, these data were not calculated. | Week 24 & 48 | 
| Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Counts | Blood samples were obtained from participants at baseline, 24, and 48 weeks after the start of Kaletra treatment and analyzed for CD4 cell counts. Change in CD4 cell counts in the main surveillance population was calculated by subtracting the value at baseline from the value at 24 weeks. Change in CD4 cell counts in the long-term surveillance population was calculated by subtracting the value at baseline from the value at 48 weeks. | From baseline to Weeks 24 and 48 | 
| Percentage of Participants With Confirmed Viral Resistance | Blood samples were obtained from participants at initiation of Kaletra treatment and follow up visits through weeks 24 and 48 and analyzed for genotypic viral resistance. | From baseline through weeks 24 and 48 | 
| Mean Time to Treatment Failure | Blood samples were obtained from participants at initiation of Kaletra treatment and at follow up visits through weeks 24 and 48 and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels. Treatment failure was defined as HIV RNA level > 400 copies/mL at week 24 and HIV RNA level > 50 copies/mL at week 48. | From baseline through weeks 24 and 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postmarketing Drug Surveillance, HIV-1 infection, Kaletra