Surveillance of Kaletra in Korean Patients

HIV-1 Infection Clinical Trial

Official title:

Post-Marketing Surveillance of Safety and Efficacy of Kaletra® Tablet in Korean Patients Under the "New Drug Re-Examination"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01083173
• Other study ID #: P11-068
• Status: Completed
• Phase: N/A
• First received: February 19, 2010
• Last updated: January 25, 2016
• Start date: October 2009
• Est. completion date: October 2014

Study information

• Verified date: January 2016
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 595
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 99 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV-1 Infection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events	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	Yes
Primary	Number of Participants Who Interrupted or Discontinued 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	Yes
Primary	Percentage of Participants With Viral Load Below 400 Copies/mL	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	No
Primary	Percentage of Participants With Viral Load Below 50 Copies/mL	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	No
Secondary	Change From Baseline in Viral Load	This variable, change from baseline in viral load, was not included in the final protocol. Therefore, these data were not calculated.	Week 24 & 48	No
Secondary	Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Counts	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	No
Secondary	Percentage of Participants With Confirmed Viral Resistance	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	No
Secondary	Mean Time to Treatment Failure	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	No

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