Drug Use Investigation of Kaletra - Full Text View

Purpose

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.

Condition	Intervention
Human Immunodeficiency Virus	Drug: Lopinavir/ritonavir (Kaletra)

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Drug Use Investigation of Kaletra

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Ritonavir Lopinavir

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Total Number of Patients With Adverse Drug Reactions [ Time Frame: During the course of the survey period up to Year 8 ] [ Designated as safety issue: Yes ]
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.
Cluster of Differentiation 4 Lymphocyte Count (CD4) [ Time Frame: 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 ] [ Designated as safety issue: No ]
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.
Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each Visit [ Time Frame: 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 ] [ Designated as safety issue: No ]
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.
Number of Patients Included in Each Center for Disease Control and Prevention (CDC) Classification Category for HIV-infected Adults and Adolescents [ Time Frame: Baseline (Month 0) and following last treatment dose during the course of the survey period ] [ Designated as safety issue: No ]
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).

Enrollment:	1184
Study Start Date:	December 2000
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Hospital

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01076972

Locations

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

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Yo Hoshino

Abbott Japan Co.,Ltd

More Information

No publications provided

Responsible Party:	Abbott
ClinicalTrials.gov Identifier:	NCT01076972 History of Changes
Other Study ID Numbers:	PMOS-JAP-00-001
Study First Received:	February 25, 2010
Results First Received:	December 9, 2011
Last Updated:	January 31, 2012
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Abbott:

Human Immunodeficiency Virus

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Ritonavir

Lopinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013