Surveillance of Kaletra in Korean Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01083173
First received: February 19, 2010
Last updated: September 9, 2014
Last verified: September 2014

February 19, 2010
September 9, 2014
October 2009
November 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
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 ]
  • Change from baseline in cluster of differentiation 4 (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 ]
  • 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"

About 600 patients who are prescribed Kaletra® treatment will be registered in the study and be treated with Kaletra® in accordance with the approved Korean product labeling and observed for up to 48 weeks following the first dose of Kaletra® tablet. Baseline data will be obtained at inclusion including demographics, Human Immunodeficiency Virus-1 diagnosis history, clinical/immunological.virological/laboratory status, other prior and concomitant disease history, prior anti-retroviral therapy history, Kaletra-containing regimen information and concomitant medication information. At routine follow-up visits which will occur according to usual medical practice, clinical/immunological/virological/laboratory status, Kaletra-containing regimen information, concomitant medication information and adverse events information will be obtained.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

general hospitals

HIV-1 Infection
Not Provided
Patients with HIV-1 infection
Those with condition
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
555
November 2014
November 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients with HIV-1 infection
  • Patients who are prescribed Kaletra® treatment as investigator's medical judgment
  • Patients who gave verbal or written authorization to use their personal and health data
  • Patients starting Kaletra® treatment after study agreement is in place

Exclusion Criteria:

  • Patients with known hypersensitivity to lopinavir, ritonavir or any excipients of Kaletra® tablet
  • Patients who are 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 trial
Both
2 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01083173
P11-068
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Deborah Chee, MD AbbVie Ltd.
AbbVie
September 2014

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