Drug Use Investigation of Kaletra

This non-interventional, post-marketing observational study was conducted to obtain data, such as safety and effectiveness, from the use of lopinavir/ritonavir (Kaletra) in clinical practice and investigate the necessity to conduct a follow-up post-marketing clinical study in Japan.

Study Overview

• Status: Completed
• Conditions: Human Immunodeficiency Virus
• Intervention / Treatment: Drug: Lopinavir/ritonavir (Kaletra)

• Study Type: Observational
• Enrollment (Actual): 1184

Contacts and Locations

Study Locations

• Japan
  • Aichi, Japan
    • Site Reference ID/Investigator# 36516
  • Aichi, Japan
    • Site Reference ID/Investigator# 36517
  • Chiba, Japan
    • Site Reference ID/Investigator# 36518
  • Fukuoka, Japan
    • Site Reference ID/Investigator# 36519
  • Fukuoka, Japan
    • Site Reference ID/Investigator# 36521
  • Hiroshima, Japan
    • Site Reference ID/Investigator# 36522
  • Hokkaido, Japan
    • Site Reference ID/Investigator# 36523
  • Hyogo, Japan
    • Site Reference ID/Investigator# 36524
  • Kanagawa, Japan
    • Site Reference ID/Investigator# 36525
  • Kyoto, Japan
    • Site Reference ID/Investigator# 36526
  • Miyagi, Japan
    • Site Reference ID/Investigator# 36622
  • Miyagi, Japan
    • Site Reference ID/Investigator# 36623
  • Niigata, Japan
    • Site Reference ID/Investigator# 36624
  • Okayama, Japan
    • Site Reference ID/Investigator# 36625
  • Osaka, Japan
    • Site Reference ID/Investigator# 36626
  • Osaka, Japan
    • Site Reference ID/Investigator# 36627
  • Shizuoka, Japan
    • Site Reference ID/Investigator# 36628
  • Tokyo, Japan
    • Site Reference ID/Investigator# 36629
  • Tokyo, Japan
    • Site Reference ID/Investigator# 36630
  • Tokyo, Japan
    • Site Reference ID/Investigator# 36631
  • Tokyo, Japan
    • Site Reference ID/Investigator# 36632
  • Tokyo, Japan
    • Site Reference ID/Investigator# 36633
  • Tokyo, Japan
    • Site Reference ID/Investigator# 36634
  • Tokyo, Japan
    • Site Reference ID/Investigator# 36635
  • Tokyo, Japan
    • Site Reference ID/Investigator# 36636
  • Tokyo, Japan
    • Site Reference ID/Investigator# 36637
  • Tokyo, Japan
    • Site Reference ID/Investigator# 36638
  • Tokyo, Japan
    • Site Reference ID/Investigator# 36639
  • Tokyo, Japan
    • Site Reference ID/Investigator# 5342

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hospital

Description

Inclusion Criteria:

• All patients prescribed Kaletra for the treatment of HIV are eligible for this survey.

Exclusion Criteria:

• Contraindications according to the Package Insert:

  • Patients with a history of hypersensitivity to any ingredient of Kaletra
  • Patients who are receiving pimozide, cisapride, ergotamine tartrate, dihydroergotamine mesylate, ergometrine maleate, methylergometrine maleate, midazolam, triazolam, vardenafil hydrochloride hydrate, boriconazol

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lopinavir/ritonavir group; All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.	Drug: Lopinavir/ritonavir (Kaletra); Lopinavir/ritonavir evaluated separately in patients who were naive to previous antiretroviral treatment and those who were not.; Other Names: Lopinavir/ritonavir; Kaletra

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Number of Patients With Adverse Drug Reactions	Number of patients with adverse drug reactions, defined as adverse events for which the causal relationship with Kaletra was something other than "not related" by the investigator (i.e., "probable," "possible," or "unclear"), that occurred in ≥ 5% of patients. Adverse drug reactions are reported by preferred term and inclusive of all those reported at each visit. Although a patient may experience a particular preferred term more than once, each patient was counted only once for each preferred term.	During the course of the survey period up to Year 8
Cluster of Differentiation 4 Lymphocyte Count (CD4)	The evolution of patients' CD4-positive (CD4+) T-lymphocyte counts after starting treatment with Kaletra was assessed by measuring the number of CD4+ cells at baseline and each subsequent study visit. CD4+ counts are reported as the number of CD4+ cells per cubic millimeter (cmm) and presented by the mean at each visit. Only observed cases were included in analyses; no data were imputed. n = xx, xx is the number of patients naive to previous antiretroviral treatment and those that were not who had CD4+ T-cell counts available for analysis at each study visit.	Baseline (Month 0), every 3 months thereafter up to Month 12 and every year thereafter up to Year 8 (Month 96) during the course of the survey period
Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each Visit	Number of HIV RNA copies per mL is presented by the mean per visit for patients that were naive to previous antiretroviral treatment and those that were not. HIV-RNA data reported as < 400 copies/mL were considered 399 copies/mL in calculations. The mean and standard deviation of HIV-RNA levels were thus calculated after logarithmic (base 10) transformation (log10 399 is 2.6). Only observed cases were included in analyses; no data were imputed. n = xx, xx is the number of treatment-naive, treatment-experienced participants who had CD4+ T-cell counts available for analysis at each study visit.	Baseline (Month 0), every 3 months thereafter up to Month 12 and every year thereafter up to Year 8 (Month 96) during the course of the survey period
Number of Patients Included in Each Center for Disease Control and Prevention (CDC) Classification Category for HIV-infected Adults and Adolescents	Number of patients in each CDC category at Baseline (last assessment within 30 days prior to first dose of Kaletra) and after treatment. CDC categories defined as: Category A (asymptomatic acute HIV infection), Category B (symptomatic HIV infection; not Categories A and C), Category C (acquired immunodeficiency syndrome [AIDS] indicator status), Class P-0 (children not confirmed for HIV infection), Class P-1 (children with asymptomatic HIV infection), or Class P-2 (children with symptomatic HIV infection).	Baseline (Month 0) and following last treatment dose during the course of the survey period

Collaborators and Investigators

• Sponsor: Abbott
• Investigators: Study Director: Yo Hoshino, Abbott Japan Co.,Ltd

Study record dates

Study Major Dates

• Study Start: December 1, 2000
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: February 25, 2010
• First Submitted That Met QC Criteria: February 25, 2010
• First Posted (Estimate): February 26, 2010

Study Record Updates

• Last Update Posted (Estimate): March 1, 2012
• Last Update Submitted That Met QC Criteria: January 31, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Human Immunodeficiency Virus
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Ritonavir; Lopinavir
• Other Study ID Numbers: PMOS-JAP-00-001