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Study on the Usage, Dosing, Tolerability, and Effectiveness of Kaletra Tablet

This study is currently recruiting participants.
Verified April 2013 by AbbVie
Sponsor:
Collaborator:
Veeda Clinical Research, Belgium
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01097655
First received: February 26, 2010
Last updated: April 16, 2013
Last verified: April 2013
History of Changes
  Purpose

Usage, dosing, tolerability, and effectiveness of Kaletra tablets in Human Immunodeficiency Virus-infected patients.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: PMOS: Kaletra Tolerability

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Effectiveness Analysis: Cluster of differentiation 4 (CD4 count) [ Time Frame: Baseline, week 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144 ] [ Designated as safety issue: No ]
  • Effectiveness Analysis: Viral load [ Time Frame: Baseline, week 4, 12, 24, 36, 48, 60, 72, 84 , 96, 108, 120, 132 and 144 ] [ Designated as safety issue: No ]

Estimated Enrollment: 3000
Study Start Date: August 2006
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group A, HIV-infected patients
Group A: treatment-naïve patients starting with KALETRA tablets
 Drug: Lopinavir/Ritonavir (Kaletra)
  • Group A: 2 tablets 2xdaily Kaletra
  • Group B: Any protease inhibitor or any non nucleoside reverse transcriptase inhibitor, followed by 2 tablets 2x daily Kaletra
Other Name: ABT-378/r
Group B, HIV-infected patients
Group B: patients receiving their first Protease Inhibitor-containing regimen (apart from KALETRA) or any Non Nucleoside Reverse Transcriptase Inhibitor-containing regimen before starting with KALETRA tablets.
 Drug: Lopinavir/Ritonavir (Kaletra)
  • Group A: 2 tablets 2xdaily Kaletra
  • Group B: Any protease inhibitor or any non nucleoside reverse transcriptase inhibitor, followed by 2 tablets 2x daily Kaletra
Other Name: ABT-378/r

Detailed Description:

The objective of this study is to observe and collect data on the usage, dosing, tolerability, and effectiveness of Kaletra tablet. In some patients the study is to show the impact of changing therapy to Kaletra tablet from other regimens on tolerability.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  • Community sample; Human Immunodeficiency Virus-infected patients
  • For Belgium: AIDS references centers (probability sample)
Criteria

Inclusion Criteria:

  • Patients with Human Immunodeficiency Virus infection
  • Patients that will be treated with KALETRA tablets, independent from their participation in this study
  • Patients > or = 18 years

Exclusion Criteria:

  • Hypersensitivity against Kaletra or other ingredients
  • Severe liver insufficiency
  • No concommitant astemizole, terfenadine, oral midazolam, triazolam, cisapride, pimozide, amiodarone, ergotamine, dihydroergotamine, ergometrine, methylergometrine, vardenafil and St. John's wort
  • Patients that received more than 1 protease inhibitor during their therapy history are excluded
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097655

Contacts
Contact: Koenig Bettina, PhD #49 6122 581062 koenig.bettina@abbvie.com
Contact: Elisabeth Glaser-Caldow #49 6122 581235 elisabeth.glaser@abbvie.com

  Hide Study Locations
Locations
Belgium
Site Reference ID/Investigator# 27827 Completed
Antwerp, Belgium, 2000
Site Reference ID/Investigator# 6129 Completed
Brussels, Belgium, 1200
Site Reference ID/Investigator# 27825 Completed
Charleroi, Belgium, 6000
Site Reference ID/Investigator# 27823 Completed
Ghent, Belgium, 9000
Site Reference ID/Investigator# 27822 Completed
Leuven, Belgium, 3000
Site Reference ID/Investigator# 27824 Completed
Liege, Belgium, 4000
Site Reference ID/Investigator# 27826 Completed
Liege, Belgium, 4000
Germany
Site Reference ID/Investigator# 28521 Recruiting
Aachen, Germany, 52062
Principal Investigator: Site Reference ID/Investigator# 28521            
Site Reference ID/Investigator# 29271 Recruiting
Berlin, Germany, 10707
Principal Investigator: Site Reference ID/Investigator# 29271            
Site Reference ID/Investigator# 32383 Recruiting
Berlin, Germany, 14057
Principal Investigator: Site Reference ID/Investigator# 32383            
Site Reference ID/Investigator# 28484 Recruiting
Berlin, Germany, 10719
Principal Investigator: Site Reference ID/Investigator# 28484            
Site Reference ID/Investigator# 28485 Recruiting
Berlin, Germany, 10439
Principal Investigator: Site Reference ID/Investigator# 28485            
Site Reference ID/Investigator# 28486 Recruiting
Berlin, Germany, D-10243
Principal Investigator: Site Reference ID/Investigator# 28486            
Site Reference ID/Investigator# 28514 Recruiting
Berlin, Germany, 10117
Principal Investigator: Site Reference ID/Investigator# 28514            
Site Reference ID/Investigator# 28522 Recruiting
Berlin, Germany, 10961
Principal Investigator: Site Reference ID/Investigator# 28522            
Site Reference ID/Investigator# 29154 Recruiting
Berlin, Germany, 13353
Principal Investigator: Site Reference ID/Investigator# 29154            
Site Reference ID/Investigator# 28518 Recruiting
Berlin, Germany, 10777
Principal Investigator: Site Reference ID/Investigator# 28518            
Site Reference ID/Investigator# 28494 Recruiting
Berlin, Germany, 10969
Principal Investigator: Site Reference ID/Investigator# 28494            
Site Reference ID/Investigator# 28496 Recruiting
Berlin, Germany, 10627
Principal Investigator: Site Reference ID/Investigator# 28496            
Site Reference ID/Investigator# 32384 Recruiting
Berlin, Germany, 14057
Principal Investigator: Site Reference ID/Investigator# 32384            
Site Reference ID/Investigator# 28569 Recruiting
Berlin, Germany, 13347
Principal Investigator: Site Reference ID/Investigator# 28569            
Site Reference ID/Investigator# 28503 Recruiting
Berlin, Germany, 10405
Principal Investigator: Site Reference ID/Investigator# 28503            
Site Reference ID/Investigator# 28504 Recruiting
Berlin, Germany, 14057
Principal Investigator: Site Reference ID/Investigator# 28504            
Site Reference ID/Investigator# 59472 Recruiting
Berlin, Germany, 10243
Principal Investigator: Site Reference ID/Investigator# 59472            
Site Reference ID/Investigator# 28559 Recruiting
Berlin, Germany, 10777
Principal Investigator: Site Reference ID/Investigator# 28559            
Site Reference ID/Investigator# 29147 Recruiting
Berlin, Germany, 10551
Principal Investigator: Site Reference ID/Investigator# 29147            
Site Reference ID/Investigator# 28557 Recruiting
Berlin, Germany, 10178
Principal Investigator: Site Reference ID/Investigator# 28557            
Site Reference ID/Investigator# 47146 Recruiting
Berlin, Germany, 10405
Principal Investigator: Site Reference ID/Investigator# 47146            
Site Reference ID/Investigator# 28567 Recruiting
Berlin, Germany, 14057
Principal Investigator: Site Reference ID/Investigator# 28567            
Site Reference ID/Investigator# 28488 Recruiting
Bochum, Germany, D-44791
Principal Investigator: Site Reference ID/Investigator# 28488            
Site Reference ID/Investigator# 28562 Recruiting
Bonn, Germany, 53127
Principal Investigator: Site Reference ID/Investigator# 28562            
Site Reference ID/Investigator# 59469 Recruiting
Bremen, Germany, 28779
Principal Investigator: Site Reference ID/Investigator# 59469            
Site Reference ID/Investigator# 29269 Recruiting
Bremen, Germany, 28203
Principal Investigator: Site Reference ID/Investigator# 29269            
Site Reference ID/Investigator# 28563 Recruiting
Cologne, Germany, 50679
Principal Investigator: Site Reference ID/Investigator# 28563            
Site Reference ID/Investigator# 28495 Recruiting
Cologne, Germany, 50931
Principal Investigator: Site Reference ID/Investigator# 28495            
Site Reference ID/Investigator# 28554 Recruiting
Cologne, Germany, 50674
Principal Investigator: Site Reference ID/Investigator# 28554            
Site Reference ID/Investigator# 29262 Recruiting
Cologne, Germany, 50674
Principal Investigator: Site Reference ID/Investigator# 29262            
Site Reference ID/Investigator# 28571 Recruiting
Cologne, Germany, 50674
Principal Investigator: Site Reference ID/Investigator# 28571            
Site Reference ID/Investigator# 28516 Recruiting
Dortmund, Germany, 44137
Principal Investigator: Site Reference ID/Investigator# 28516            
Site Reference ID/Investigator# 47142 Recruiting
Dortmund, Germany, 44145
Principal Investigator: Site Reference ID/Investigator# 47142            
Site Reference ID/Investigator# 28491 Recruiting
Duesseldorf, Germany, 40223
Principal Investigator: Site Reference ID/Investigator# 28491            
Site Reference ID/Investigator# 28547 Recruiting
Duesseldorf, Germany, 40237
Principal Investigator: Site Reference ID/Investigator# 28547            
Site Reference ID/Investigator# 28524 Recruiting
Duisburg, Germany, 47259
Principal Investigator: Site Reference ID/Investigator# 28524            
Site Reference ID/Investigator# 28520 Recruiting
Frankfurt, Germany, 60596
Principal Investigator: Site Reference ID/Investigator# 28520            
Site Reference ID/Investigator# 28545 Recruiting
Frankfurt, Germany, 60311
Principal Investigator: Site Reference ID/Investigator# 28545            
Site Reference ID/Investigator# 29270 Recruiting
Frankfurt, Germany, 60318
Principal Investigator: Site Reference ID/Investigator# 29270            
Site Reference ID/Investigator# 29260 Recruiting
Frankfurt am Main, Germany, 60590
Principal Investigator: Site Reference ID/Investigator# 29260            
Site Reference ID/Investigator# 28550 Recruiting
Freiburg, Germany, 79098
Principal Investigator: Site Reference ID/Investigator# 28550            
Site Reference ID/Investigator# 28564 Recruiting
Freiburg, Germany, 79098
Principal Investigator: Site Reference ID/Investigator# 28564            
Site Reference ID/Investigator# 29266 Recruiting
Freiburg, Germany, 79106
Principal Investigator: Site Reference ID/Investigator# 29266            
Site Reference ID/Investigator# 28570 Recruiting
Fuerth, Germany, D-90762
Principal Investigator: Site Reference ID/Investigator# 28570            
Site Reference ID/Investigator# 28498 Recruiting
Giessen, Germany, 35390
Principal Investigator: Site Reference ID/Investigator# 28498            
Site Reference ID/Investigator# 32382 Recruiting
Hamburg, Germany, 20146
Principal Investigator: Site Reference ID/Investigator# 32382            
Site Reference ID/Investigator# 29261 Recruiting
Hamburg, Germany, 20099
Principal Investigator: Site Reference ID/Investigator# 29261            
Site Reference ID/Investigator# 28549 Recruiting
Hamburg, Germany, 20357
Principal Investigator: Site Reference ID/Investigator# 28549            
Site Reference ID/Investigator# 28515 Recruiting
Hamburg, Germany, 20146
Principal Investigator: Site Reference ID/Investigator# 28515            
Site Reference ID/Investigator# 29272 Recruiting
Hamburg, Germany, 20095
Principal Investigator: Site Reference ID/Investigator# 29272            
Site Reference ID/Investigator# 28513 Recruiting
Hamburg, Germany, 20246
Principal Investigator: Site Reference ID/Investigator# 28513            
Site Reference ID/Investigator# 29267 Recruiting
Hamburg, Germany, 20246
Principal Investigator: Site Reference ID/Investigator# 29267            
Site Reference ID/Investigator# 28507 Recruiting
Hamburg, Germany, 20354
Principal Investigator: Site Reference ID/Investigator# 28507            
Site Reference ID/Investigator# 32386 Recruiting
Hamburg, Germany, 20146
Principal Investigator: Site Reference ID/Investigator# 32386            
Site Reference ID/Investigator# 28489 Recruiting
Hamburg, Germany, 20146
Principal Investigator: Site Reference ID/Investigator# 28489            
Site Reference ID/Investigator# 28544 Recruiting
Hamburg, Germany, 20354
Principal Investigator: Site Reference ID/Investigator# 28544            
Site Reference ID/Investigator# 28566 Recruiting
Hamburg, Germany, 20099
Principal Investigator: Site Reference ID/Investigator# 28566            
Site Reference ID/Investigator# 28568 Recruiting
Hannover, Germany, 30625
Principal Investigator: Site Reference ID/Investigator# 28568            
Site Reference ID/Investigator# 29273 Recruiting
Hanover, Germany, 30171
Principal Investigator: Site Reference ID/Investigator# 29273            
Site Reference ID/Investigator# 28523 Recruiting
Hanover, Germany, 30159
Principal Investigator: Site Reference ID/Investigator# 28523            
Site Reference ID/Investigator# 47145 Recruiting
Heidelberg, Germany, 69115
Principal Investigator: Site Reference ID/Investigator# 47145            
Site Reference ID/Investigator# 28551 Recruiting
Karlsruhe, Germany, 76135
Principal Investigator: Site Reference ID/Investigator# 28551            
Site Reference ID/Investigator# 28561 Recruiting
Koblenz, Germany, 56065
Principal Investigator: Site Reference ID/Investigator# 28561            
Site Reference ID/Investigator# 28483 Recruiting
Krefeld, Germany, 47800
Principal Investigator: Site Reference ID/Investigator# 28483            
Site Reference ID/Investigator# 47144 Recruiting
Leipzig, Germany, 04107
Principal Investigator: Site Reference ID/Investigator# 47144            
Site Reference ID/Investigator# 28482 Recruiting
Leipzig, Germany, 04107
Principal Investigator: Site Reference ID/Investigator# 28482            
Site Reference ID/Investigator# 28493 Recruiting
Ludwigshafen, Germany, 67063
Principal Investigator: Site Reference ID/Investigator# 28493            
Site Reference ID/Investigator# 28500 Recruiting
Luebeck, Germany, 23538
Principal Investigator: Site Reference ID/Investigator# 28500            
Site Reference ID/Investigator# 59468 Recruiting
Magdeburg, Germany, 39120
Principal Investigator: Site Reference ID/Investigator# 59468            
Site Reference ID/Investigator# 28574 Recruiting
Mainz, Germany, 55131
Principal Investigator: Site Reference ID/Investigator# 28574            
Site Reference ID/Investigator# 28565 Recruiting
Mainz, Germany, 55116
Principal Investigator: Site Reference ID/Investigator# 28565            
Site Reference ID/Investigator# 28490 Recruiting
Muenster, Germany, 48143
Principal Investigator: Site Reference ID/Investigator# 28490            
Site Reference ID/Investigator# 28560 Recruiting
Muenster, Germany, 48149
Principal Investigator: Site Reference ID/Investigator# 28560            
Site Reference ID/Investigator# 28492 Recruiting
Muenster, Germany, 48143
Principal Investigator: Site Reference ID/Investigator# 28492            
Site Reference ID/Investigator# 28505 Recruiting
Munich, Germany, 80801
Principal Investigator: Site Reference ID/Investigator# 28505            
Site Reference ID/Investigator# 28548 Recruiting
Munich, Germany, 80801
Principal Investigator: Site Reference ID/Investigator# 28548            
Site Reference ID/Investigator# 28508 Recruiting
Munich, Germany, 80801
Principal Investigator: Site Reference ID/Investigator# 28508            
Site Reference ID/Investigator# 28519 Recruiting
Munich, Germany, 80337
Principal Investigator: Site Reference ID/Investigator# 28519            
Site Reference ID/Investigator# 28517 Recruiting
Munich, Germany, 80335
Principal Investigator: Site Reference ID/Investigator# 28517            
Site Reference ID/Investigator# 28556 Recruiting
Munich, Germany, 80331
Principal Investigator: Site Reference ID/Investigator# 28556            
Site Reference ID/Investigator# 5346 Recruiting
Nuremberg, Germany, 90461
Principal Investigator: Site Reference ID/Investigator# 5346            
Site Reference ID/Investigator# 28555 Recruiting
Oldenburg, Germany, 26121
Principal Investigator: Site Reference ID/Investigator# 28555            
Site Reference ID/Investigator# 28553 Recruiting
Osnabrueck, Germany, 49076
Principal Investigator: Site Reference ID/Investigator# 28553            
Site Reference ID/Investigator# 59467 Recruiting
Rostock, Germany, 18057
Principal Investigator: Site Reference ID/Investigator# 59467            
Site Reference ID/Investigator# 28506 Recruiting
Saarbruecken, Germany, 66111
Principal Investigator: Site Reference ID/Investigator# 28506            
Site Reference ID/Investigator# 59471 Recruiting
Schkeuditz, Germany, 04435
Principal Investigator: Site Reference ID/Investigator# 59471            
Site Reference ID/Investigator# 28552 Recruiting
Stuttgart, Germany, 70197
Principal Investigator: Site Reference ID/Investigator# 28552            
Site Reference ID/Investigator# 29265 Recruiting
Stuttgart, Germany, 70197
Principal Investigator: Site Reference ID/Investigator# 29265            
Site Reference ID/Investigator# 28572 Recruiting
Troisdorf, Germany, 53840
Principal Investigator: Site Reference ID/Investigator# 28572            
Site Reference ID/Investigator# 28511 Recruiting
Tuebingen, Germany, 72072
Principal Investigator: Site Reference ID/Investigator# 28511            
Site Reference ID/Investigator# 29264 Recruiting
Wiesbaden, Germany, 65197
Principal Investigator: Site Reference ID/Investigator# 29264            
Site Reference ID/Investigator# 28546 Recruiting
Wuppertal, Germany, 42277
Principal Investigator: Site Reference ID/Investigator# 28546            
Israel
Site Reference ID/Investigator# 27833 Recruiting
Be'er-Sheva, Israel, 84101
Principal Investigator: Site Reference ID/Investigator# 27833            
Site Reference ID/Investigator# 17549 Recruiting
Haifa, Israel, 31096
Principal Investigator: Site Reference ID/Investigator# 17549            
Site Reference ID/Investigator# 27830 Recruiting
Jerusalem, Israel, 91120
Principal Investigator: Site Reference ID/Investigator# 27830            
Site Reference ID/Investigator# 27832 Recruiting
Kfar Saba, Israel, 44281
Principal Investigator: Site Reference ID/Investigator# 27832            
Site Reference ID/Investigator# 27829 Recruiting
Rechovot, Israel, 76100
Principal Investigator: Site Reference ID/Investigator# 27829            
Site Reference ID/Investigator# 27831 Recruiting
Tel-Hashomer, Israel
Principal Investigator: Site Reference ID/Investigator# 27831            
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Veeda Clinical Research, Belgium
Investigators
Study Director: Stefan Simianer, MD AbbVie Deutschland GmbH & Co. KG, Medical Department
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01097655     History of Changes
Other Study ID Numbers: P06-131
Study First Received: February 26, 2010
Last Updated: April 16, 2013
Health Authority: Israel: Ministry of Health
Belgium: Institutional Review Board
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AbbVie:
Viral load
Tolerability
Human immunodeficiency Virus
Treatment-naïve
 Non Nucleoside Reverse Transcriptase Inhibitor
Tablets
Infection
Effectiveness

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
Protease Inhibitors
Ritonavir
 Lopinavir
Reverse Transcriptase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
HIV Protease Inhibitors
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 23, 2013