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Completed

NCT Number: NCT01083173

Surveillance of Kaletra in Korean Patients

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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Key information

Conditions

HIV-1 Infection

Age range

2 year–99 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of Participants With Adverse Events

    Time frame: 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.

  2. Number of Participants Who Interrupted or Discontinued Kaletra Treatment

    Time frame: 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).

  3. Percentage of Participants With Viral Load Below 400 Copies/mL

    Time frame: 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.

  4. Percentage of Participants With Viral Load Below 50 Copies/mL

    Time frame: 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 outcomes

  1. Change From Baseline in Viral Load

    Time frame: Week 24 & 48

    This variable, change from baseline in viral load, was not included in the final protocol. Therefore, these data were not calculated.

  2. Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Counts

    Time frame: 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.

  3. Percentage of Participants With Confirmed Viral Resistance

    Time frame: 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.

  4. Mean Time to Treatment Failure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Mar 9, 2010
Registry last updated
Feb 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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