Surveillance of Kaletra in Korean Patients

Completed

Brief 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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Viral Load Below 400 Copies/mL	Week 24	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.
Number of Participants With Adverse Events	From the start of treatment until 30 days after the last dose, up to 52 weeks	Adverse events were recorded during the 48-week surveillance period and until 30 days following the last dose.
Number of Participants Who Interrupted or Discontinued Kaletra Treatment	Weeks 24 and 48 after initiation of Kaletra treatment or upon permanent discontinuation of 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).
Percentage of Participants With Viral Load Below 50 Copies/mL	Week 48	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Viral Load	Week 24 & 48	This variable, change from baseline in viral load, was not included in the final protocol. Therefore, these data were not calculated.
Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Counts	From baseline to Weeks 24 and 48	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.
Percentage of Participants With Confirmed Viral Resistance	From baseline through weeks 24 and 48	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.
Mean Time to Treatment Failure	From baseline through weeks 24 and 48	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.