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Evaluation of Kaletra Therapy Over the Long-term

NCT ID: NCT01083810

Last Updated: 2011-08-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

284 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-06-30

Study Completion Date

2010-06-30

Brief Summary

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Long term observation of patients under lopinavir/ritonavir containing therapy

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Detailed Description

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Three to five year observation of lopinavir/ritonavir therapy. Reporting groups are 1) therapy-naïve patients (144 weeks), 2) therapy-experienced but protease inhibitor naïve patients (240 weeks,) and 3) non-B subtype infected patients (240 weeks).

These three groups of participants with HIV-1 infection were at first registered as three different studies: KAL1RO (this study, NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55) but were now reconciled under KAL1RO (NCT01083810) as a single study with three reporting groups.

Conditions

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Human Immunodeficiency Virus

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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therapy-naive

Patients who had not received prior antiretroviral drug therapy

Lopinavir/Ritonavir (Kaletra)

Intervention Type DRUG

3 capsules 2xdaily or 2 tablets 2xdaily Kaletra

pre-treated

Patients that had previously received antiretroviral therapy, but are protease inhibitor naive

Lopinavir/Ritonavir (Kaletra)

Intervention Type DRUG

3 capsules 2xdaily or 2 tablets 2xdaily Kaletra

non-B

Patients infected with non-B subtypes of HIV-1

Lopinavir/Ritonavir (Kaletra)

Intervention Type DRUG

3 capsules 2xdaily or 2 tablets 2xdaily Kaletra

Interventions

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Lopinavir/Ritonavir (Kaletra)

3 capsules 2xdaily or 2 tablets 2xdaily Kaletra

Intervention Type DRUG

Other Intervention Names

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ABT-378/r Kaletra Lopinavir/Ritonavir

Eligibility Criteria

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Inclusion Criteria

* Patients infected by HIV-1
* Age greater than or equal to 18 years

Exclusion Criteria

* as described in SmPC (summary of product characteristics) at the time of prescription
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Medical Department, Abbott Germany (Wiesbaden)

Principal Investigators

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Stefan Simianer, MD

Role: STUDY_DIRECTOR

Abbott Germany, Medical Department

Locations

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Site Ref # / Investigator 27706

Aachen, , Germany

Site Status

Site Ref # / Investigator 52972

Aachen, , Germany

Site Status

Site Ref # / Investigator 27660

Berlin, , Germany

Site Status

Site Ref # / Investigator 27937

Berlin, , Germany

Site Status

Site Ref # / Investigator 52973

Berlin, , Germany

Site Status

Site Reference ID/Investigator# 27629

Berlin, , Germany

Site Status

Site Ref # / Investigator 27651

Berlin, , Germany

Site Status

Site Ref # / Investigator 27912

Berlin, , Germany

Site Status

Site Reference ID/Investigator# 27544

Berlin, , Germany

Site Status

Site Reference ID/Investigator# 27567

Berlin, , Germany

Site Status

Site Ref # / Investigator 27929

Berlin, , Germany

Site Status

Site Ref # / Investigator 52971

Berlin, , Germany

Site Status

Site Ref # / Investigator 53468

Berlin, , Germany

Site Status

Site Ref # / Investigator 27965

Berlin, , Germany

Site Status

Site Reference ID/Investigator# 27547

Berlin, , Germany

Site Status

Site Reference ID/Investigator# 27552

Berlin, , Germany

Site Status

Site Reference ID/Investigator# 27562

Berlin, , Germany

Site Status

Site Ref # / Investigator 52984

Berlin, , Germany

Site Status

Site Ref # / Investigator 27639

Berlin, , Germany

Site Status

Site Ref # / Investigator 52970

Berlin, , Germany

Site Status

Site Ref # / Investigator 27909

Berlin, , Germany

Site Status

Site Ref # / Investigator 47113

Berlin, , Germany

Site Status

Site Reference ID/Investigator# 27574

Chemnitz, , Germany

Site Status

Site Ref # / Investigator 28060

Cologne, , Germany

Site Status

Site Ref # / Investigator 52978

Cologne, , Germany

Site Status

Site Ref # / Investigator 27932

Cologne, , Germany

Site Status

Site Ref # / Investigator 52979

Cologne, , Germany

Site Status

Site Ref # / Investigator 48233

Cologne, , Germany

Site Status

Site Ref # / Investigator 52985

Cologne, , Germany

Site Status

Site Ref # / Investigator 53464

Cologne, , Germany

Site Status

Site Ref # / Investigator 27704

Dortmund, , Germany

Site Status

Site Ref # / Investigator 27947

Dortmund, , Germany

Site Status

Site Ref # / Investigator 52968

Dortmund, , Germany

Site Status

Site Reference ID/Investigator# 27558

Duisburg, , Germany

Site Status

Site Ref # / Investigator 28056

Düsseldorf, , Germany

Site Status

Site Ref # / Investigator 52983

Frankfurt, , Germany

Site Status

Site Ref # / Investigator 27928

Frankfurt, , Germany

Site Status

Site Ref # / Investigator 52967

Frankfurt, , Germany

Site Status

Site Reference ID/Investigator# 27565

Freiburg im Breisgau, , Germany

Site Status

Site Reference ID/Investigator# 27566

Fürth, , Germany

Site Status

Site Ref # / Investigator 53465

Fürth, , Germany

Site Status

Site Ref # / Investigator 27931

Hamburg, , Germany

Site Status

Site Ref # / Investigator 27982

Hamburg, , Germany

Site Status

Site Ref # / Investigator 47114

Hamburg, , Germany

Site Status

Site Ref # / Investigator 47115

Hamburg, , Germany

Site Status

Site Reference ID/Investigator# 27551

Hamburg, , Germany

Site Status

Site Reference ID/Investigator# 27634

Hamburg, , Germany

Site Status

Site Ref # / Investigator 30864

Hamburg, , Germany

Site Status

Site Ref # / Investigator 5348

Hamburg, , Germany

Site Status

Site Reference ID/Investigator# 27546

Hamburg, , Germany

Site Status

Site Ref # / Investigator 28032

Hamburg, , Germany

Site Status

Site Ref # / Investigator 52969

Hamburg, , Germany

Site Status

Site Ref # / Investigator 53467

Hamburg, , Germany

Site Status

Site Ref # / Investigator 52980

Hamburg, , Germany

Site Status

Site Ref # / Investigator 27641

Karlsruhe, , Germany

Site Status

Site Ref # / Investigator 27964

Karlsruhe, , Germany

Site Status

Site Reference ID/Investigator# 27561

Karlsruhe, , Germany

Site Status

Site Ref # / Investigator 53466

Koblenz, , Germany

Site Status

Site Reference ID/Investigator# 27555

Koblenz, , Germany

Site Status

Site Ref # / Investigator 27905

Krefeld, , Germany

Site Status

Site Ref # / Investigator 27906

Leipzig, , Germany

Site Status

Site Ref # / Investigator 52975

Leipzig, , Germany

Site Status

Site Ref # / Investigator 53463

Leipzig, , Germany

Site Status

Site Ref # / Investigator 27948

Ludwigshafen, , Germany

Site Status

Site Ref # / Investigator 52977

Ludwigshafen, , Germany

Site Status

Site Ref # / Investigator 27902

Mainz, , Germany

Site Status

Site Reference ID/Investigator# 27543

Mainz, , Germany

Site Status

Site Ref # / Investigator 28104

Mönchengladbach, , Germany

Site Status

Site Ref # / Investigator 52981

Mönchengladbach, , Germany

Site Status

Site Ref # / Investigator 27949

Munich, , Germany

Site Status

Site Reference ID/Investigator# 27553

Munich, , Germany

Site Status

Site Ref # / Investigator 27926

Munich, , Germany

Site Status

Site Ref # / Investigator 53462

Munich, , Germany

Site Status

Site Ref # / Investigator 27648

Münster, , Germany

Site Status

Site Reference ID/Investigator# 27568

Münster, , Germany

Site Status

Site Ref # / Investigator 52982

Nuremberg, , Germany

Site Status

Site Ref # / Investigator 27988

Oldenburg, , Germany

Site Status

Site Reference ID/Investigator# 27563

Oldenburg, , Germany

Site Status

Site Ref # / Investigator 27637

Osnabrück, , Germany

Site Status

Site Ref # / Investigator 27943

Osnabrück, , Germany

Site Status

Site Ref # / Investigator 52974

Osnabrück, , Germany

Site Status

Site Ref # / Investigator 27939

Paderborn, , Germany

Site Status

Site Ref # / Investigator 27649

Rostock, , Germany

Site Status

Site Reference ID/Investigator# 27569

Rostock, , Germany

Site Status

Site Ref # / Investigator 27647

Stuttgart, , Germany

Site Status

Site Ref # / Investigator 28047

Stuttgart, , Germany

Site Status

Site Ref # / Investigator 28048

Stuttgart, , Germany

Site Status

Site Reference ID/Investigator# 27631

Stuttgart, , Germany

Site Status

Site Ref # / Investigator 52976

Troisdorf, , Germany

Site Status

Site Ref # / Investigator 27961

Wuppertal, , Germany

Site Status

Countries

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Germany

Other Identifiers

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KAL 1 RO

Identifier Type: -

Identifier Source: org_study_id

NCT01081470

Identifier Type: -

Identifier Source: nct_alias

NCT01083836

Identifier Type: -

Identifier Source: nct_alias

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