Surveillance of Kaletra in Korean Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01083173
First received: February 19, 2010
Last updated: January 25, 2016
Last verified: January 2016
  Purpose
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.

Condition
HIV-1 Infection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post-Marketing Surveillance of Safety and Efficacy of Kaletra® Tablet in Korean Patients Under the "New Drug Re-Examination"

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Number of Participants With Adverse Events [ Time Frame: From the start of treatment until 30 days after the last dose, up to 52 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Weeks 24 and 48 after initiation of Kaletra treatment or upon permanent discontinuation of Kaletra treatment ] [ Designated as safety issue: Yes ]
    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 400 Copies/mL [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Viral Load Below 50 Copies/mL [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    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:
  • Change From Baseline in Viral Load [ Time Frame: Week 24 & 48 ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline to Weeks 24 and 48 ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline through weeks 24 and 48 ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline through weeks 24 and 48 ] [ Designated as safety issue: No ]
    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.


Enrollment: 595
Study Start Date: October 2009
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Participants with HIV-1 infection
Participants treated with Kaletra (lopinavir/ritonavir 200 mg/50 mg and 100 mg/25 mg) tablet

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.
  Eligibility

Ages Eligible for Study:   2 Years to 99 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
general hospitals
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01083173

Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: SoRa Lee, MD AbbVie Ltd.
  More Information

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01083173     History of Changes
Other Study ID Numbers: P11-068 
Study First Received: February 19, 2010
Results First Received: October 30, 2015
Last Updated: January 25, 2016
Health Authority: Korea: Food and Drug Administration

Keywords provided by AbbVie:
Postmarketing Drug Surveillance
HIV-1 infection
Kaletra

Additional relevant MeSH terms:
Lopinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 28, 2016