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Kaletra: Therapy With Double Protease Inhibitors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01075191
First received: February 23, 2010
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

Therapy with lopinavir/ritonavir (Kaletra) and one other protease inhibitor in Human Immunodeficiency Virus participants


Condition
Human Immunodeficiency Virus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: PMOS: Kaletra Double Protease Inhibitors

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 65
Study Start Date: January 2004
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).


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.

  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 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
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: NCT01075191

Locations
Germany
Site Reference ID/Investigator# 28109
Berlin, Germany, D-10243
Site Reference ID/Investigator# 28123
Berlin, Germany, 13347
Site Reference ID/Investigator# 28131
Berlin, Germany, 10551
Site Reference ID/Investigator# 48283
Berlin, Germany, 10439
Site Reference ID/Investigator# 66422
Berlin, Germany, 10961
Site Reference ID/Investigator# 28115
Dortmund, Germany, 44137
Site Reference ID/Investigator# 28119
Frankfurt, Germany, 60596
Site Reference ID/Investigator# 28124
Frankfurt, Germany, 60311
Site Reference ID/Investigator# 28127
Frankfurt, Germany, 60329
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# 28113
Munich, Germany, 80801
Site Reference ID/Investigator# 28118
Munich, Germany, 80337
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

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01075191     History of Changes
Other Study ID Numbers: P05-103
Study First Received: February 23, 2010
Results First Received: September 28, 2012
Last Updated: January 14, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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
HIV Protease Inhibitors
Protease Inhibitors
Reverse Transcriptase Inhibitors
Anti-HIV Agents
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 November 20, 2014