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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by AbbVie
Sponsor:
Collaborator:
Veeda Clinical Research
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01097655
First received: February 26, 2010
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

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


Condition
Human Immunodeficiency Virus

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

Resource links provided by NLM:


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: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group A, HIV-infected patients
Group A: treatment-naïve patients starting with KALETRA tablets
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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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# 27826 Completed
Liege, Belgium, 4000
Site Reference ID/Investigator# 27824 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# 29259 Withdrawn
Berlin, Germany, 10997
Site Reference ID/Investigator# 59472 Recruiting
Berlin, Germany, 10243
Principal Investigator: Site Reference ID/Investigator# 59472         
Site Reference ID/Investigator# 28484 Recruiting
Berlin, Germany, 10719
Principal Investigator: Site Reference ID/Investigator# 28484         
Site Reference ID/Investigator# 28518 Recruiting
Berlin, Germany, 10777
Principal Investigator: Site Reference ID/Investigator# 28518         
Site Reference ID/Investigator# 32383 Recruiting
Berlin, Germany, 14057
Principal Investigator: Site Reference ID/Investigator# 32383         
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# 28494 Recruiting
Berlin, Germany, 10969
Principal Investigator: Site Reference ID/Investigator# 28494         
Site Reference ID/Investigator# 28559 Recruiting
Berlin, Germany, 10777
Principal Investigator: Site Reference ID/Investigator# 28559         
Site Reference ID/Investigator# 28485 Recruiting
Berlin, Germany, 10439
Principal Investigator: Site Reference ID/Investigator# 28485         
Site Reference ID/Investigator# 28514 Recruiting
Berlin, Germany, 10117
Principal Investigator: Site Reference ID/Investigator# 28514         
Site Reference ID/Investigator# 28486 Withdrawn
Berlin, Germany, 10243
Site Reference ID/Investigator# 28503 Recruiting
Berlin, Germany, 10405
Principal Investigator: Site Reference ID/Investigator# 28503         
Site Reference ID/Investigator# 47146 Recruiting
Berlin, Germany, 10405
Principal Investigator: Site Reference ID/Investigator# 47146         
Site Reference ID/Investigator# 29271 Recruiting
Berlin, Germany, 10707
Principal Investigator: Site Reference ID/Investigator# 29271         
Site Reference ID/Investigator# 28567 Recruiting
Berlin, Germany, 14057
Principal Investigator: Site Reference ID/Investigator# 28567         
Site Reference ID/Investigator# 28543 Withdrawn
Berlin, Germany, 12487
Site Reference ID/Investigator# 28569 Recruiting
Berlin, Germany, 13347
Principal Investigator: Site Reference ID/Investigator# 28569         
Site Reference ID/Investigator# 28573 Withdrawn
Berlin, Germany, 10627
Site Reference ID/Investigator# 125596 Recruiting
Berlin, Germany, 10243
Principal Investigator: Site Reference ID/Investigator# 125596         
Site Reference ID/Investigator# 32384 Recruiting
Berlin, Germany, 14057
Principal Investigator: Site Reference ID/Investigator# 32384         
Site Reference ID/Investigator# 28522 Recruiting
Berlin, Germany, 10961
Principal Investigator: Site Reference ID/Investigator# 28522         
Site Reference ID/Investigator# 28504 Recruiting
Berlin, Germany, 14057
Principal Investigator: Site Reference ID/Investigator# 28504         
Site Reference ID/Investigator# 29154 Recruiting
Berlin, Germany, 13353
Principal Investigator: Site Reference ID/Investigator# 29154         
Site Reference ID/Investigator# 28510 Withdrawn
Berlin, Germany, 10589
Site Reference ID/Investigator# 28496 Recruiting
Berlin, Germany, 10627
Principal Investigator: Site Reference ID/Investigator# 28496         
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# 29269 Recruiting
Bremen, Germany, 28203
Principal Investigator: Site Reference ID/Investigator# 29269         
Site Reference ID/Investigator# 59469 Recruiting
Bremen, Germany, 28779
Principal Investigator: Site Reference ID/Investigator# 59469         
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# 28563 Recruiting
Cologne, Germany, 50679
Principal Investigator: Site Reference ID/Investigator# 28563         
Site Reference ID/Investigator# 29258 Withdrawn
Cologne, Germany, 50672
Site Reference ID/Investigator# 28495 Recruiting
Cologne, Germany, 50931
Principal Investigator: Site Reference ID/Investigator# 28495         
Site Reference ID/Investigator# 28512 Withdrawn
Cologne, Germany, 50667
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# 59470 Withdrawn
Duesseldorf, Germany, 40227
Site Reference ID/Investigator# 28547 Recruiting
Duesseldorf, Germany, 40237
Principal Investigator: Site Reference ID/Investigator# 28547         
Site Reference ID/Investigator# 28497 Withdrawn
Duesseldorf, Germany, 40477
Site Reference ID/Investigator# 114175 Recruiting
Duesseldorf, Germany, 40237
Principal Investigator: Site Reference ID/Investigator# 114175         
Site Reference ID/Investigator# 28491 Recruiting
Duesseldorf, Germany, 40223
Principal Investigator: Site Reference ID/Investigator# 28491         
Site Reference ID/Investigator# 28524 Recruiting
Duisburg, Germany, 47259
Principal Investigator: Site Reference ID/Investigator# 28524         
Site Reference ID/Investigator# 47143 Withdrawn
Essen, Germany, 45122
Site Reference ID/Investigator# 29270 Recruiting
Frankfurt, Germany, 60318
Principal Investigator: Site Reference ID/Investigator# 29270         
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# 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# 29263 Withdrawn
Freiburg, Germany, 79106
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# 28544 Recruiting
Hamburg, Germany, 20354
Principal Investigator: Site Reference ID/Investigator# 28544         
Site Reference ID/Investigator# 28513 Recruiting
Hamburg, Germany, 20246
Principal Investigator: Site Reference ID/Investigator# 28513         
Site Reference ID/Investigator# 28549 Recruiting
Hamburg, Germany, 20357
Principal Investigator: Site Reference ID/Investigator# 28549         
Site Reference ID/Investigator# 29261 Recruiting
Hamburg, Germany, 20099
Principal Investigator: Site Reference ID/Investigator# 29261         
Site Reference ID/Investigator# 29267 Recruiting
Hamburg, Germany, 20246
Principal Investigator: Site Reference ID/Investigator# 29267         
Site Reference ID/Investigator# 28515 Recruiting
Hamburg, Germany, 20146
Principal Investigator: Site Reference ID/Investigator# 28515         
Site Reference ID/Investigator# 32382 Recruiting
Hamburg, Germany, 20146
Principal Investigator: Site Reference ID/Investigator# 32382         
Site Reference ID/Investigator# 32386 Recruiting
Hamburg, Germany, 20146
Principal Investigator: Site Reference ID/Investigator# 32386         
Site Reference ID/Investigator# 28507 Recruiting
Hamburg, Germany, 20354
Principal Investigator: Site Reference ID/Investigator# 28507         
Site Reference ID/Investigator# 28566 Recruiting
Hamburg, Germany, 20099
Principal Investigator: Site Reference ID/Investigator# 28566         
Site Reference ID/Investigator# 28489 Recruiting
Hamburg, Germany, 20146
Principal Investigator: Site Reference ID/Investigator# 28489         
Site Reference ID/Investigator# 29272 Recruiting
Hamburg, Germany, 20095
Principal Investigator: Site Reference ID/Investigator# 29272         
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# 28487 Withdrawn
Heidelberg, Germany, 69115
Site Reference ID/Investigator# 47145 Recruiting
Heidelberg, Germany, 69115
Principal Investigator: Site Reference ID/Investigator# 47145         
Site Reference ID/Investigator# 32385 Withdrawn
Heidelberg, Germany, 69115
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# 28565 Recruiting
Mainz, Germany, 55116
Principal Investigator: Site Reference ID/Investigator# 28565         
Site Reference ID/Investigator# 28574 Recruiting
Mainz, Germany, 55131
Principal Investigator: Site Reference ID/Investigator# 28574         
Site Reference ID/Investigator# 28560 Recruiting
Muenster, Germany, 48149
Principal Investigator: Site Reference ID/Investigator# 28560         
Site Reference ID/Investigator# 28490 Recruiting
Muenster, Germany, 48143
Principal Investigator: Site Reference ID/Investigator# 28490         
Site Reference ID/Investigator# 28492 Recruiting
Muenster, Germany, 48143
Principal Investigator: Site Reference ID/Investigator# 28492         
Site Reference ID/Investigator# 28501 Withdrawn
Muenster, Germany, 48149
Site Reference ID/Investigator# 28509 Withdrawn
Muenster, Germany, 48149
Site Reference ID/Investigator# 28517 Recruiting
Munich, Germany, 80335
Principal Investigator: Site Reference ID/Investigator# 28517         
Site Reference ID/Investigator# 28519 Recruiting
Munich, Germany, 80337
Principal Investigator: Site Reference ID/Investigator# 28519         
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# 28556 Recruiting
Munich, Germany, 80331
Principal Investigator: Site Reference ID/Investigator# 28556         
Site Reference ID/Investigator# 28508 Recruiting
Munich, Germany, 80801
Principal Investigator: Site Reference ID/Investigator# 28508         
Site Reference ID/Investigator# 28502 Withdrawn
Munich, Germany, 80801
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# 28499 Withdrawn
Pforzheim, Germany, 75177
Site Reference ID/Investigator# 102655 Recruiting
Potsdam, Germany, 14467
Principal Investigator: Site Reference ID/Investigator# 102655         
Site Reference ID/Investigator# 59467 Recruiting
Rostock, Germany, 18057
Principal Investigator: Site Reference ID/Investigator# 59467         
Site Reference ID/Investigator# 28542 Withdrawn
Saarbruecken, Germany, 66121
Site Reference ID/Investigator# 29268 Withdrawn
Saarbruecken, Germany, 66111
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# 29265 Recruiting
Stuttgart, Germany, 70197
Principal Investigator: Site Reference ID/Investigator# 29265         
Site Reference ID/Investigator# 28552 Recruiting
Stuttgart, Germany, 70197
Principal Investigator: Site Reference ID/Investigator# 28552         
Site Reference ID/Investigator# 28572 Recruiting
Troisdorf, Germany, 53840
Principal Investigator: Site Reference ID/Investigator# 28572         
Site Reference ID/Investigator# 28558 Withdrawn
Tuebingen, Germany, 72076
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, 91120O1
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
Investigators
Study Director: Bianca Wittig, MD AbbVie Deutschland GmbH & Co. KG, Medical Department
  More Information

Additional Information:
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: May 16, 2014
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
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014