Surveillance of Kaletra in Korean Patients
This study is enrolling participants by invitation only.
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: April 26, 2013
Last verified: April 2013
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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 | Intervention |
|---|---|
|
HIV-1 Infection |
Drug: Lopinavir/Ritonavir (Kaletra) |
| 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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
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: | 600 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Patients with HIV-1 infection
Those with condition
|
Drug: Lopinavir/Ritonavir (Kaletra)
Lopinavir/Ritonavir (Kaletra) (200/50mg) tablet, 2 tablets twice a day or 4 tablets once daily
|
Eligibility| Ages Eligible for Study: | 19 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
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# 84595 | |
| Chungbuk, Korea, Republic of, 361-240 | |
| Site Reference ID/Investigator# 27722 | |
| Daegu, Korea, Republic of, 700-712 | |
| Site Reference ID/Investigator# 27719 | |
| Daegu, Korea, Republic of, 700-721 | |
| 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 | |
| Jeollabuk-do, Korea, Republic of, 651-180 | |
| Site Reference ID/Investigator# 27736 | |
| Seongnam, Korea, Republic of, 463-712 | |
| Site Reference ID/Investigator# 20061 | |
| Seoul, Korea, Republic of, 140-887 | |
| Site Reference ID/Investigator# 53591 | |
| Seoul, Korea, Republic of, 158-710 | |
| Site Reference ID/Investigator# 27721 | |
| Seoul, Korea, Republic of, 135-720 | |
| 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# 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# 27723 | |
| Seoul, Korea, Republic of, 100-799 | |
| 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: | April 26, 2013 |
| 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 Ritonavir Lopinavir |
HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013