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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

February 19, 2010
January 25, 2016
October 2009
October 2014   (final data collection date for primary outcome measure)
  • 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.
  • Adverse events [ Time Frame: About one month after the initiation of Kaletra®-containing regimen, then at an average interval of 3 months ] [ Designated as safety issue: Yes ]
  • Number of subjects who interrupt or discontinue Kaletra-containing regimen [ Time Frame: Week 24 & 48 ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with viral load below 400 copies/mL [ Time Frame: Week 24 & 48 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01083173 on ClinicalTrials.gov Archive Site
  • 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.
  • Change From Baseline in Viral Load [ Time Frame: Week 24 & 48 ] [ Designated as safety issue: No ]
  • Change from baseline in CD4 counts [ Time Frame: Week 24 & 48 ] [ Designated as safety issue: No ]
  • Subjects with confirmed resistance [ Time Frame: Week 24 and 48 ] [ Designated as safety issue: No ]
  • Time to treatment failure [ Time Frame: Week 24 & 48 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Surveillance of Kaletra in Korean Patients
Post-Marketing Surveillance of Safety and Efficacy of Kaletra® Tablet in Korean Patients Under the "New Drug Re-Examination"
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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
general hospitals
HIV-1 Infection
Not Provided
Participants with HIV-1 infection
Participants treated with Kaletra (lopinavir/ritonavir 200 mg/50 mg and 100 mg/25 mg) tablet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
595
October 2014
October 2014   (final data collection date for primary outcome measure)

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
Both
2 Years to 99 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Korea, Republic of
 
NCT01083173
P11-068
No
Not Provided
Not Provided
AbbVie (prior sponsor, Abbott)
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: SoRa Lee, MD AbbVie Ltd.
AbbVie
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP