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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

February 26, 2010
April 16, 2013
August 2006
November 2017   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01097655 on ClinicalTrials.gov Archive Site
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Study on the Usage, Dosing, Tolerability, and Effectiveness of Kaletra Tablet
PMOS: Kaletra Tolerability

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

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
  • Community sample; Human Immunodeficiency Virus-infected patients
  • For Belgium: AIDS references centers (probability sample)
Human Immunodeficiency Virus
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 A, HIV-infected patients
    Group A: treatment-naïve patients starting with KALETRA tablets
    Intervention: Drug: Lopinavir/Ritonavir (Kaletra)
  • 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.
    Intervention: Drug: Lopinavir/Ritonavir (Kaletra)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3000
November 2017
November 2017   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Koenig Bettina, PhD #49 6122 581062 koenig.bettina@abbvie.com
Contact: Elisabeth Glaser-Caldow #49 6122 581235 elisabeth.glaser@abbvie.com
Belgium,   Germany,   Israel
 
NCT01097655
P06-131
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Veeda Clinical Research, Belgium
Study Director: Stefan Simianer, MD AbbVie Deutschland GmbH & Co. KG, Medical Department
AbbVie
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP