Surveillance of Kaletra in Korean Patients

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01083173
First received: February 19, 2010
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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.


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:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 555
Study Start Date: October 2009
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with HIV-1 infection
Those with condition

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

general hospitals

Criteria

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
  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

Locations
Korea, Republic of
Site Reference ID/Investigator# 27709
Ansan, Korea, Republic of, 152-703
Site Reference ID/Investigator# 27715
Bucheon, Korea, Republic of, 420-767
Site Reference ID/Investigator# 27713
Busan, Korea, Republic of, 602-739
Site Reference ID/Investigator# 27714
Busan, Korea, Republic of, 633-165
Site Reference ID/Investigator# 27712
Busan, Korea, Republic of, 602-739
Site Reference ID/Investigator# 27720
Busan, Korea, Republic of, 602-812
Site Reference ID/Investigator# 84613
Changwon, Korea, Republic of, 630-520
Site Reference ID/Investigator# 119435
Cheonan, Korea, Republic of, 330-715
Site Reference ID/Investigator# 84595
Chungbuk, Korea, Republic of, 361-240
Site Reference ID/Investigator# 27722
Daegu, Korea, Republic of, 700-712
Site Reference ID/Investigator# 119437
Daegu, Korea, Republic of, 705-703
Site Reference ID/Investigator# 27719
Daegu, Korea, Republic of, 702-210
Site Reference ID/Investigator# 27729
Daejeon, Korea, Republic of, 302-799
Site Reference ID/Investigator# 88253
Daejeon, Korea, Republic of, 301-721
Site Reference ID/Investigator# 119436
Goyang, Korea, Republic of, 410-719
Site Reference ID/Investigator# 27725
Gwangju, Korea, Republic of, 501-757
Site Reference ID/Investigator# 27737
Incheon, Korea, Republic of, 405-760
Site Reference ID/Investigator# 27716
Incheon, Korea, Republic of, 400-711
Site Reference ID/Investigator# 119438
Jeju, Korea, Republic of, 690-767
Site Reference ID/Investigator# 27708
Jeonju, Korea, Republic of, 651-180
Site Reference ID/Investigator# 27710
Jinju, Korea, Republic of, 660-702
Site Reference ID/Investigator# 66655
Koyang-shi, Korea, Republic of, 410-719
Site Reference ID/Investigator# 27736
Seongnam, Korea, Republic of, 463-712
Site Reference ID/Investigator# 27727
Seoul, Korea, Republic of, 136-705
Site Reference ID/Investigator# 27730
Seoul, Korea, Republic of, 134-709
Site Reference ID/Investigator# 27728
Seoul, Korea, Republic of, 152-703
Site Reference ID/Investigator# 27735
Seoul, Korea, Republic of, 138-736
Site Reference ID/Investigator# 27738
Seoul, Korea, Republic of, 137-701
Site Reference ID/Investigator# 27732
Seoul, Korea, Republic of, 134-709
Site Reference ID/Investigator# 27731
Seoul, Korea, Republic of, 150-030
Site Reference ID/Investigator# 27723
Seoul, Korea, Republic of, 100-799
Site Reference ID/Investigator# 27726
Seoul, Korea, Republic of, 156-755
Site Reference ID/Investigator# 27721
Seoul, Korea, Republic of, 135-720
Site Reference ID/Investigator# 20061
Seoul, Korea, Republic of, 140-887
Site Reference ID/Investigator# 84594
Seoul, Korea, Republic of, 135-740
Site Reference ID/Investigator# 27734
Seoul, Korea, Republic of, 120-752
Site Reference ID/Investigator# 53591
Seoul, Korea, Republic of, 158-710
Site Reference ID/Investigator# 27724
Suwon-si, Korea, Republic of, 443-721
Site Reference ID/Investigator# 27718
Ulsan, Korea, Republic of, 682-714
Site Reference ID/Investigator# 27717
Wonju, Korea, Republic of, 220-701
Site Reference ID/Investigator# 42062
Yangsan, Korea, Republic of, 626-770
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Deborah Chee, MD AbbVie Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01083173     History of Changes
Other Study ID Numbers: P11-068
Study First Received: February 19, 2010
Last Updated: July 22, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by AbbVie:
Postmarketing Drug Surveillance

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on August 19, 2014