Clinical trial NCT01083173: Surveillance of Kaletra in Korean Patients
Official title: Post-Marketing Surveillance of Safety and Efficacy of Kaletra® Tablet in Korean Patients Under the "New Drug Re-Examination"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-1 Infection
Keywords: Postmarketing Drug Surveillance
HIV-1 infection
Kaletra
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2010-03-09
Enrollment: 595
Sex: ALL
Minimum age (years): 2
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: general hospitals

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: From the start of treatment until 30 days after the last dose, up to 52 weeks
measure: Number of Participants Who Interrupted or Discontinued Kaletra Treatment
timeFrame: Weeks 24 and 48 after initiation of Kaletra treatment or upon permanent discontinuation of Kaletra treatment
measure: Percentage of Participants With Viral Load Below 400 Copies/mL
timeFrame: Week 24
measure: Percentage of Participants With Viral Load Below 50 Copies/mL
timeFrame: Week 48
Secondary outcomes:
measure: Change From Baseline in Viral Load
timeFrame: Week 24 & 48
measure: Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Counts
timeFrame: From baseline to Weeks 24 and 48
measure: Percentage of Participants With Confirmed Viral Resistance
timeFrame: From baseline through weeks 24 and 48
measure: Mean Time to Treatment Failure
timeFrame: From baseline through weeks 24 and 48
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie Ltd.
name: SoRa Lee, MD
role: STUDY_DIRECTOR
References: