ClinicalTrials.gov
ClinicalTrials.gov Menu

Surveillance of Kaletra in Korean Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01083173
Recruitment Status : Completed
First Posted : March 9, 2010
Results First Posted : February 22, 2016
Last Update Posted : February 22, 2016
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Description
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
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.

Study Design
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 595 participants
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"
Study Start Date : October 2009
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Lopinavir
U.S. FDA Resources

Groups and Cohorts
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Participants with HIV-1 infection
Participants treated with Kaletra (lopinavir/ritonavir 200 mg/50 mg and 100 mg/25 mg) tablet


Outcome Measures
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 99 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01083173


Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: SoRa Lee, MD AbbVie Ltd.
More Information
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01083173     History of Changes
Other Study ID Numbers: P11-068
First Posted: March 9, 2010    Key Record Dates
Results First Posted: February 22, 2016
Last Update Posted: February 22, 2016
Last Verified: January 2016

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
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