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Kaletra: Therapy With Double Protease Inhibitors

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ClinicalTrials.gov Identifier: NCT01075191
Recruitment Status : Completed
First Posted : February 25, 2010
Results First Posted : October 30, 2012
Last Update Posted : January 18, 2013
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Description
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Brief Summary:
Therapy with lopinavir/ritonavir (Kaletra) and one other protease inhibitor in Human Immunodeficiency Virus participants

Condition or disease
Human Immunodeficiency Virus

Detailed Description:
This study is intended to observe and collect data on the usage, dosing, tolerability, and effectiveness of lopinavir/ritonavir (Kaletra) when used as part of a Nucleoside Reverse Transcriptase Inhibitors-free double protease regimen. Enrollment in the study was independent of the decision to prescribe Kaletra.

Study Design
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Study Type : Observational
Actual Enrollment : 65 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PMOS: Kaletra Double Protease Inhibitors
Study Start Date : January 2004
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

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

Groups and Cohorts
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Group/Cohort
HIV-infected participants

HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.

Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (three 133 mg/33 mg capsules twice daily or two 200 mg/50 mg tablets twice daily).


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL [ Time Frame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 ]
    Viral load (number of HIV-1 RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments. The percentage of participants with HIV RNA less than 50 copies/mL at each time point is presented.


Secondary Outcome Measures :
  1. Change From Baseline in Absolute CD4 Cell Count [ Time Frame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 ]
    Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.

  2. Change From Baseline in Relative CD4 Cell Count [ Time Frame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 ]
    Increases in relative CD4 count (the percentage of total lymphocytes that are CD4 cells) are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the percentage of CD4+ cells at scheduled study visits.

  3. Change From Baseline in Absolute CD8 Cell Count [ Time Frame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 ]
    Decreases in CD8 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD8-positive (CD8+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD8+ cells at scheduled study visits.

  4. Change From Baseline in Relative CD8 Cell Count [ Time Frame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 ]
    Decreases in relative CD8 count (the percentage of total lymphocytes that are CD8 cells) are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD8-positive (CD8+) T-lymphocyte counts were assessed by measuring the change from Baseline in the percentage of CD8+ cells at scheduled study visits.

  5. Change From Baseline in CD4/CD8 T-cell Ratio [ Time Frame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 ]
    The CD4/CD8 T-cell ratio, also known as the T-lymphocyte helper/suppressor profile, presents the number of lymphocytes in the blood positive for CD4 cells compared with the number positive for CD8 cells. Changes in participants' CD4/CD8 T-lymphocyte ratio were assessed by measuring the change from Baseline in the ratio at scheduled study visits.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community sample; Human Immunodeficiency Virus-infected participants
Criteria

Inclusion Criteria:

  • Participants with Human Immunodeficiency Virus infection
  • Participants on lopinavir/ritonavir (Kaletra) and one other protease inhibitor

Exclusion Criteria:

  • Hypersensitivity against lopinavir, ritonavir or other ingredients
  • Severe liver insufficiency
  • No concomitant astemizole, terfenadine, oral midazolam, triazolam, cisapride, pimozide, amiodarone, ergotamine, dihydroergotamine, ergometrine, methylergometrine, vardenafil and St. John's wort
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01075191


Locations
Germany
Site Reference ID/Investigator# 48283
Berlin, Germany, 10439
Site Reference ID/Investigator# 28131
Berlin, Germany, 10551
Site Reference ID/Investigator# 66422
Berlin, Germany, 10961
Site Reference ID/Investigator# 28123
Berlin, Germany, 13347
Site Reference ID/Investigator# 28109
Berlin, Germany, D-10243
Site Reference ID/Investigator# 28115
Dortmund, Germany, 44137
Site Reference ID/Investigator# 28124
Frankfurt, Germany, 60311
Site Reference ID/Investigator# 28127
Frankfurt, Germany, 60329
Site Reference ID/Investigator# 28119
Frankfurt, Germany, 60596
Site Reference ID/Investigator# 5318
Krefeld, Germany, 47800
Site Reference ID/Investigator# 28112
Ludwigshafen, Germany, 67063
Site Reference ID/Investigator# 28111
Muenster, Germany, 48143
Site Reference ID/Investigator# 28129
Muenster, Germany, 48149
Site Reference ID/Investigator# 28118
Munich, Germany, 80337
Site Reference ID/Investigator# 28113
Munich, Germany, 80801
Site Reference ID/Investigator# 28133
Stuttgart, Germany, 70197
Site Reference ID/Investigator# 28126
Wuppertal, Germany, 42277
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Stefan Simianer, MD AbbVie Deutschland GmbH & Co. KG, Medical Department
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01075191     History of Changes
Other Study ID Numbers: P05-103
First Posted: February 25, 2010    Key Record Dates
Results First Posted: October 30, 2012
Last Update Posted: January 18, 2013
Last Verified: January 2013

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Viral load
Resistance
Double protease inhibitors
Mutations
 Immune system
Infection
Nucleoside Reverse Transcriptase Inhibitors-free
Human Immunodeficiency Virus

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
 Protease Inhibitors
Lopinavir
HIV Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors