- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01083173
Surveillance of Kaletra in Korean Patients
January 25, 2016 updated by: AbbVie (prior sponsor, Abbott)
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.
Study Overview
Status
Completed
Conditions
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
595
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 99 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
general hospitals
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Participants with HIV-1 infection
Participants treated with Kaletra (lopinavir/ritonavir 200 mg/50 mg and 100 mg/25 mg) tablet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Adverse Events
Time Frame: From the start of treatment until 30 days after the last dose, up to 52 weeks
|
Adverse events were recorded during the 48-week surveillance period and until 30 days following the last dose.
|
From the start of treatment until 30 days after the last dose, up to 52 weeks
|
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
|
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).
|
Weeks 24 and 48 after initiation of Kaletra treatment or upon permanent discontinuation of Kaletra treatment
|
Percentage of Participants With Viral Load Below 400 Copies/mL
Time Frame: Week 24
|
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.
|
Week 24
|
Percentage of Participants With Viral Load Below 50 Copies/mL
Time Frame: Week 48
|
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.
|
Week 48
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Viral Load
Time Frame: Week 24 & 48
|
This variable, change from baseline in viral load, was not included in the final protocol.
Therefore, these data were not calculated.
|
Week 24 & 48
|
Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Counts
Time Frame: From baseline to Weeks 24 and 48
|
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.
|
From baseline to Weeks 24 and 48
|
Percentage of Participants With Confirmed Viral Resistance
Time Frame: From baseline through weeks 24 and 48
|
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.
|
From baseline through weeks 24 and 48
|
Mean Time to Treatment Failure
Time Frame: From baseline through weeks 24 and 48
|
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.
|
From baseline through weeks 24 and 48
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: SoRa Lee, MD, AbbVie Ltd.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
February 19, 2010
First Submitted That Met QC Criteria
March 8, 2010
First Posted (Estimate)
March 9, 2010
Study Record Updates
Last Update Posted (Estimate)
February 22, 2016
Last Update Submitted That Met QC Criteria
January 25, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P11-068
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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