Surveillance of Kaletra in Korean Patients
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ClinicalTrials.gov Identifier: NCT01083173 |
Recruitment Status
:
Completed
First Posted
: March 9, 2010
Results First Posted
: February 22, 2016
Last Update Posted
: February 22, 2016
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Condition or disease |
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HIV-1 Infection |
Study Type : | Observational |
Actual Enrollment : | 595 participants |
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" |
Study Start Date : | October 2009 |
Actual Primary Completion Date : | October 2014 |
Actual Study Completion Date : | October 2014 |

Group/Cohort |
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Participants with HIV-1 infection
Participants treated with Kaletra (lopinavir/ritonavir 200 mg/50 mg and 100 mg/25 mg) tablet
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- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.

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Ages Eligible for Study: | 2 Years to 99 Years (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01083173
Study Director: | SoRa Lee, MD | AbbVie Ltd. |
Additional Information:
Responsible Party: | AbbVie (prior sponsor, Abbott) |
ClinicalTrials.gov Identifier: | NCT01083173 History of Changes |
Other Study ID Numbers: |
P11-068 |
First Posted: | March 9, 2010 Key Record Dates |
Results First Posted: | February 22, 2016 |
Last Update Posted: | February 22, 2016 |
Last Verified: | January 2016 |
Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Postmarketing Drug Surveillance HIV-1 infection Kaletra |
Additional relevant MeSH terms:
Lopinavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents |
Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |