Drug Use Investigation of Kaletra

NCT01076972 | Completed Results

• 1 other identifier: PMOS-JAP-00-001
• Study Type: observational
• Target: 1,184
• Locations: 1 country
• Sites: 29

Brief Summary

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.

Conditions

Human Immunodeficiency Virus

Keywords

Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

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)

Interventions

Lopinavir/ritonavir (Kaletra) DRUG

Lopinavir/ritonavir evaluated separately in patients who were naive to previous antiretroviral treatment and those who were not.

Also known as: Lopinavir/ritonavir, Kaletra

Lopinavir/ritonavir group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospital

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead

Study Sites (29)

Site Reference ID/Investigator# 36516

Aichi, Japan

Location

Site Reference ID/Investigator# 36517

Aichi, Japan

Location

Site Reference ID/Investigator# 36518

Chiba, Japan

Location

Site Reference ID/Investigator# 36519

Fukuoka, Japan

Location

Site Reference ID/Investigator# 36521

Fukuoka, Japan

Location

Site Reference ID/Investigator# 36522

Hiroshima, Japan

Location

Site Reference ID/Investigator# 36523

Hokkaido, Japan

Location

Site Reference ID/Investigator# 36524

Hyōgo, Japan

Location

Site Reference ID/Investigator# 36525

Kanagawa, Japan

Location

Site Reference ID/Investigator# 36526

Kyoto, Japan

Location

Site Reference ID/Investigator# 36622

Miyagi, Japan

Location

Site Reference ID/Investigator# 36623

Miyagi, Japan

Location

Site Reference ID/Investigator# 36624

Niigata, Japan

Location

Site Reference ID/Investigator# 36625

Okayama, Japan

Location

Site Reference ID/Investigator# 36626

Osaka, Japan

Location

Site Reference ID/Investigator# 36627

Osaka, Japan

Location

Site Reference ID/Investigator# 36628

Shizuoka, Japan

Location

Site Reference ID/Investigator# 36629

Tokyo, Japan

Location

Site Reference ID/Investigator# 36630

Tokyo, Japan

Location

Site Reference ID/Investigator# 36631

Tokyo, Japan

Location

Site Reference ID/Investigator# 36632

Tokyo, Japan

Location

Site Reference ID/Investigator# 36633

Tokyo, Japan

Location

Site Reference ID/Investigator# 36634

Tokyo, Japan

Location

Site Reference ID/Investigator# 36635

Tokyo, Japan

Location

Site Reference ID/Investigator# 36636

Tokyo, Japan

Location

Site Reference ID/Investigator# 36637

Tokyo, Japan

Location

Site Reference ID/Investigator# 36638

Tokyo, Japan

Location

Site Reference ID/Investigator# 36639

Tokyo, Japan

Location

Site Reference ID/Investigator# 5342

Tokyo, Japan

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Lopinavir; Ritonavir; lopinavir-ritonavir drug combination

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott

800-633-9110

Study Officials

• Yo Hoshino

  Abbott Japan Co.,Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2010
• First Posted: February 26, 2010
• Study Start: December 1, 2000
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 1, 2012
• Results First Posted: March 1, 2012

Record last verified: 2012-01

Locations

JP (29)