Surveillance of Kaletra in Korean Patients
This study has been completed.
Sponsor:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01083173
First received: February 19, 2010
Last updated: November 14, 2014
Last verified: November 2014
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Purpose
About 555 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 ]
| Enrollment: | 591 |
| 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 |
|---|
|
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:
- patients 2 years of age and above 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
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# 27712 | |
| Busan, Korea, Republic of, 602-739 | |
| 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# 84613 | |
| Changwon, Korea, Republic of, 630-520 | |
| Site Reference ID/Investigator# 119435 | |
| Cheonan, Korea, Republic of, 330-715 | |
| Site Reference ID/Investigator# 84595 | |
| Cheongju, Korea, Republic of, 361-240 | |
| 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# 27722 | |
| Daegu, Korea, Republic of, 700-712 | |
| Site Reference ID/Investigator# 27729 | |
| Daejeon, Korea, Republic of, 302-799 | |
| 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# 27716 | |
| Incheon, Korea, Republic of, 400-711 | |
| Site Reference ID/Investigator# 27737 | |
| Incheon, Korea, Republic of, 405-760 | |
| Site Reference ID/Investigator# 27708 | |
| Jeonju, Korea, Republic of, 651-180 | |
| 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# 84594 | |
| Seoul, Korea, Republic of, 135-740 | |
| Site Reference ID/Investigator# 27721 | |
| Seoul, Korea, Republic of, 135-720 | |
| Site Reference ID/Investigator# 27723 | |
| Seoul, Korea, Republic of, 100-799 | |
| Site Reference ID/Investigator# 20061 | |
| Seoul, Korea, Republic of, 140-887 | |
| Site Reference ID/Investigator# 27727 | |
| Seoul, Korea, Republic of, 136-705 | |
| Site Reference ID/Investigator# 27731 | |
| Seoul, Korea, Republic of, 150-030 | |
| Site Reference ID/Investigator# 27734 | |
| Seoul, Korea, Republic of, 120-752 | |
| 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# 53591 | |
| Seoul, Korea, Republic of, 158-710 | |
| Site Reference ID/Investigator# 27726 | |
| Seoul, Korea, Republic of, 156-755 | |
| 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: | November 14, 2014 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by AbbVie:
|
Postmarketing Drug Surveillance |
ClinicalTrials.gov processed this record on February 27, 2015