Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
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: February 20, 2015
Last verified: February 2015
  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: January 2005
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (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

  Hide Study Locations
Locations
Belgium
Site Reference ID/Investigator# 27827
Antwerp, Belgium, 2000
Site Reference ID/Investigator# 6129
Brussels, Belgium, 1200
Site Reference ID/Investigator# 27825
Charleroi, Belgium, 6000
Site Reference ID/Investigator# 27823
Ghent, Belgium, 9000
Site Reference ID/Investigator# 27822
Leuven, Belgium, 3000
Site Reference ID/Investigator# 27824
Liege, Belgium, 4000
Site Reference ID/Investigator# 27826
Liege, Belgium, 4000
Germany
Site Reference ID/Investigator# 28521
Aachen, Germany, 52062
Site Reference ID/Investigator# 28494
Berlin, Germany, 10969
Site Reference ID/Investigator# 28484
Berlin, Germany, 10719
Site Reference ID/Investigator# 28485
Berlin, Germany, 10439
Site Reference ID/Investigator# 59472
Berlin, Germany, 10243
Site Reference ID/Investigator# 28496
Berlin, Germany, 10627
Site Reference ID/Investigator# 28503
Berlin, Germany, 10405
Site Reference ID/Investigator# 28504
Berlin, Germany, 14057
Site Reference ID/Investigator# 28514
Berlin, Germany, 10117
Site Reference ID/Investigator# 28518
Berlin, Germany, 10777
Site Reference ID/Investigator# 28522
Berlin, Germany, 10961
Site Reference ID/Investigator# 28557
Berlin, Germany, 10178
Site Reference ID/Investigator# 28559
Berlin, Germany, 10777
Site Reference ID/Investigator# 28567
Berlin, Germany, 14057
Site Reference ID/Investigator# 28569
Berlin, Germany, 13347
Site Reference ID/Investigator# 29147
Berlin, Germany, 10551
Site Reference ID/Investigator# 29154
Berlin, Germany, 13353
Site Reference ID/Investigator# 29271
Berlin, Germany, 10707
Site Reference ID/Investigator# 32383
Berlin, Germany, 14057
Site Reference ID/Investigator# 125596
Berlin, Germany, 10243
Site Reference ID/Investigator# 47146
Berlin, Germany, 10405
Site Reference ID/Investigator# 32384
Berlin, Germany, 14057
Site Reference ID/Investigator# 28488
Bochum, Germany, D-44791
Site Reference ID/Investigator# 28562
Bonn, Germany, 53127
Site Reference ID/Investigator# 29269
Bremen, Germany, 28203
Site Reference ID/Investigator# 59469
Bremen, Germany, 28779
Site Reference ID/Investigator# 29262
Cologne, Germany, 50674
Site Reference ID/Investigator# 28495
Cologne, Germany, 50931
Site Reference ID/Investigator# 28554
Cologne, Germany, 50674
Site Reference ID/Investigator# 28571
Cologne, Germany, 50674
Site Reference ID/Investigator# 28563
Cologne, Germany, 50679
Site Reference ID/Investigator# 28516
Dortmund, Germany, 44137
Site Reference ID/Investigator# 47142
Dortmund, Germany, 44145
Site Reference ID/Investigator# 114175
Duesseldorf, Germany, 40237
Site Reference ID/Investigator# 28491
Duesseldorf, Germany, 40223
Site Reference ID/Investigator# 28547
Duesseldorf, Germany, 40237
Site Reference ID/Investigator# 28524
Duisburg, Germany, 47259
Site Reference ID/Investigator# 28545
Frankfurt, Germany, 60311
Site Reference ID/Investigator# 28520
Frankfurt, Germany, 60596
Site Reference ID/Investigator# 29270
Frankfurt, Germany, 60318
Site Reference ID/Investigator# 29260
Frankfurt am Main, Germany, 60590
Site Reference ID/Investigator# 28550
Freiburg, Germany, 79098
Site Reference ID/Investigator# 28564
Freiburg, Germany, 79098
Site Reference ID/Investigator# 29266
Freiburg, Germany, 79106
Site Reference ID/Investigator# 28570
Fuerth, Germany, D-90762
Site Reference ID/Investigator# 28498
Giessen, Germany, 35390
Site Reference ID/Investigator# 28489
Hamburg, Germany, 20146
Site Reference ID/Investigator# 28507
Hamburg, Germany, 20354
Site Reference ID/Investigator# 28513
Hamburg, Germany, 20246
Site Reference ID/Investigator# 28515
Hamburg, Germany, 20146
Site Reference ID/Investigator# 28544
Hamburg, Germany, 20354
Site Reference ID/Investigator# 28549
Hamburg, Germany, 20357
Site Reference ID/Investigator# 28566
Hamburg, Germany, 20099
Site Reference ID/Investigator# 29261
Hamburg, Germany, 20099
Site Reference ID/Investigator# 29267
Hamburg, Germany, 20246
Site Reference ID/Investigator# 29272
Hamburg, Germany, 20095
Site Reference ID/Investigator# 32382
Hamburg, Germany, 20146
Site Reference ID/Investigator# 32386
Hamburg, Germany, 20146
Site Reference ID/Investigator# 28568
Hannover, Germany, 30625
Site Reference ID/Investigator# 28523
Hanover, Germany, 30159
Site Reference ID/Investigator# 29273
Hanover, Germany, 30171
Site Reference ID/Investigator# 47145
Heidelberg, Germany, 69115
Site Reference ID/Investigator# 136739
Heidelberg, Germany, 69120
Site Reference ID/Investigator# 28551
Karlsruhe, Germany, 76135
Site Reference ID/Investigator# 28561
Koblenz, Germany, 56065
Site Reference ID/Investigator# 28483
Krefeld, Germany, 47800
Site Reference ID/Investigator# 47144
Leipzig, Germany, 04107
Site Reference ID/Investigator# 28482
Leipzig, Germany, 04107
Site Reference ID/Investigator# 28493
Ludwigshafen, Germany, 67063
Site Reference ID/Investigator# 28500
Luebeck, Germany, 23538
Site Reference ID/Investigator# 59468
Magdeburg, Germany, 39120
Site Reference ID/Investigator# 28574
Mainz, Germany, 55131
Site Reference ID/Investigator# 28565
Mainz, Germany, 55116
Site Reference ID/Investigator# 28490
Muenster, Germany, 48143
Site Reference ID/Investigator# 28492
Muenster, Germany, 48143
Site Reference ID/Investigator# 28560
Muenster, Germany, 48149
Site Reference ID/Investigator# 28556
Munich, Germany, 80331
Site Reference ID/Investigator# 136741
Munich, Germany, 81669
Site Reference ID/Investigator# 28505
Munich, Germany, 80801
Site Reference ID/Investigator# 28508
Munich, Germany, 80801
Site Reference ID/Investigator# 28517
Munich, Germany, 80335
Site Reference ID/Investigator# 28519
Munich, Germany, 80337
Site Reference ID/Investigator# 28548
Munich, Germany, 80801
Site Reference ID/Investigator# 136740
Munich, Germany, 80336
Site Reference ID/Investigator# 5346
Nuremberg, Germany, 90461
Site Reference ID/Investigator# 28555
Oldenburg, Germany, 26121
Site Reference ID/Investigator# 28553
Osnabrueck, Germany, 49076
Site Reference ID/Investigator# 102655
Potsdam, Germany, 14467
Site Reference ID/Investigator# 59467
Rostock, Germany, 18057
Site Reference ID/Investigator# 28506
Saarbruecken, Germany, 66111
Site Reference ID/Investigator# 59471
Schkeuditz, Germany, 04435
Site Reference ID/Investigator# 28552
Stuttgart, Germany, 70197
Site Reference ID/Investigator# 29265
Stuttgart, Germany, 70197
Site Reference ID/Investigator# 28572
Troisdorf, Germany, 53840
Site Reference ID/Investigator# 29264
Wiesbaden, Germany, 65197
Site Reference ID/Investigator# 28546
Wuppertal, Germany, 42277
Israel
Site Reference ID/Investigator# 27833
Be'er-Sheva, Israel, 84101
Site Reference ID/Investigator# 17549
Haifa, Israel, 31096
Site Reference ID/Investigator# 27830
Jerusalem, Israel, 91120
Site Reference ID/Investigator# 27832
Kfar Saba, Israel, 4428164
Site Reference ID/Investigator# 27829
Rechovot, Israel, 76100
Site Reference ID/Investigator# 27831
Tel-Hashomer, Israel
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: February 20, 2015
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
Immune System Diseases
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Reverse Transcriptase Inhibitors
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on March 02, 2015