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Kaletra: Therapy With Double Protease Inhibitors

NCT ID: NCT01075191

Last Updated: 2013-01-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-01-31

Study Completion Date

2011-09-30

Brief Summary

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Therapy with lopinavir/ritonavir (Kaletra) and one other protease inhibitor in Human Immunodeficiency Virus participants

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Detailed Description

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This study is intended to observe and collect data on the usage, dosing, tolerability, and effectiveness of lopinavir/ritonavir (Kaletra) when used as part of a Nucleoside Reverse Transcriptase Inhibitors-free double protease regimen. Enrollment in the study was independent of the decision to prescribe Kaletra.

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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HIV-infected participants

HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.

Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (three 133 mg/33 mg capsules twice daily or two 200 mg/50 mg tablets twice daily).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Participants with Human Immunodeficiency Virus infection
* Participants on lopinavir/ritonavir (Kaletra) and one other protease inhibitor

Exclusion Criteria

* Hypersensitivity against lopinavir, ritonavir or other ingredients
* Severe liver insufficiency
* No concomitant astemizole, terfenadine, oral midazolam, triazolam, cisapride, pimozide, amiodarone, ergotamine, dihydroergotamine, ergometrine, methylergometrine, vardenafil and St. John's wort
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefan Simianer, MD

Role: STUDY_DIRECTOR

AbbVie Deutschland GmbH & Co. KG, Medical Department

Locations

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Site Reference ID/Investigator# 48283

Berlin, , Germany

Site Status

Site Reference ID/Investigator# 28131

Berlin, , Germany

Site Status

Site Reference ID/Investigator# 66422

Berlin, , Germany

Site Status

Site Reference ID/Investigator# 28123

Berlin, , Germany

Site Status

Site Reference ID/Investigator# 28109

Berlin, , Germany

Site Status

Site Reference ID/Investigator# 28115

Dortmund, , Germany

Site Status

Site Reference ID/Investigator# 28124

Frankfurt, , Germany

Site Status

Site Reference ID/Investigator# 28127

Frankfurt, , Germany

Site Status

Site Reference ID/Investigator# 28119

Frankfurt, , Germany

Site Status

Site Reference ID/Investigator# 5318

Krefeld, , Germany

Site Status

Site Reference ID/Investigator# 28112

Ludwigshafen, , Germany

Site Status

Site Reference ID/Investigator# 28118

Munich, , Germany

Site Status

Site Reference ID/Investigator# 28113

Munich, , Germany

Site Status

Site Reference ID/Investigator# 28111

Münster, , Germany

Site Status

Site Reference ID/Investigator# 28129

Münster, , Germany

Site Status

Site Reference ID/Investigator# 28133

Stuttgart, , Germany

Site Status

Site Reference ID/Investigator# 28126

Wuppertal, , Germany

Site Status

Countries

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Germany

Related Links

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http://rxabbvie.com

Related Info

Other Identifiers

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P05-103

Identifier Type: -

Identifier Source: org_study_id

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