Drug Use Investigation of Kaletra

NCT ID: NCT01076972

Last Updated: 2012-03-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1184 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-12-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Human Immunodeficiency Virus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Lopinavir/ritonavir (Kaletra)

Intervention Type DRUG

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

Interventions

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Lopinavir/ritonavir (Kaletra)

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

Intervention Type DRUG

Other Intervention Names

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Lopinavir/ritonavir Kaletra

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yo Hoshino

Role: STUDY_DIRECTOR

Abbott Japan Co.,Ltd

Locations

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Site Reference ID/Investigator# 36516

Aichi, , Japan

Site Status

Site Reference ID/Investigator# 36517

Aichi, , Japan

Site Status

Site Reference ID/Investigator# 36518

Chiba, , Japan

Site Status

Site Reference ID/Investigator# 36519

Fukuoka, , Japan

Site Status

Site Reference ID/Investigator# 36521

Fukuoka, , Japan

Site Status

Site Reference ID/Investigator# 36522

Hiroshima, , Japan

Site Status

Site Reference ID/Investigator# 36523

Hokkaido, , Japan

Site Status

Site Reference ID/Investigator# 36524

Hyōgo, , Japan

Site Status

Site Reference ID/Investigator# 36525

Kanagawa, , Japan

Site Status

Site Reference ID/Investigator# 36526

Kyoto, , Japan

Site Status

Site Reference ID/Investigator# 36622

Miyagi, , Japan

Site Status

Site Reference ID/Investigator# 36623

Miyagi, , Japan

Site Status

Site Reference ID/Investigator# 36624

Niigata, , Japan

Site Status

Site Reference ID/Investigator# 36625

Okayama, , Japan

Site Status

Site Reference ID/Investigator# 36626

Osaka, , Japan

Site Status

Site Reference ID/Investigator# 36627

Osaka, , Japan

Site Status

Site Reference ID/Investigator# 36628

Shizuoka, , Japan

Site Status

Site Reference ID/Investigator# 36629

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 36630

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 36631

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 36632

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 36633

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 36634

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 36635

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 36636

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 36637

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 36638

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 36639

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 5342

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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PMOS-JAP-00-001

Identifier Type: -

Identifier Source: org_study_id

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