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.
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.
Study Type
OBSERVATIONAL
Enrollment
595
Number of Participants With Adverse Events
Adverse events were recorded during the 48-week surveillance period and until 30 days following the last dose.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Week 48
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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: From baseline through weeks 24 and 48