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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

  Show 105 Study Locations
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 16, 2013