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Long-term Effectiveness and Safety in Hepatitis-co-infected Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01153269
First received: February 26, 2010
Last updated: November 16, 2011
Last verified: November 2011
History of Changes
  Purpose
The aim of the study is to observe the tolerability and effectiveness of Kaletra in Human Immunodeficiency Virus/Hepatitis-B Virus and Human Immunodeficiency Virus/Hepatitis-C Virus co-infected patients.

Condition Intervention
Human Immunodeficiency Virus-Infection
 Drug: Lopinavir/Ritonavir (Kaletra)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Long-term Effectiveness and Safety in Hepatitis-co-infected Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Baseline are presented.

  • Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 4 are presented.

  • Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 12 are presented.

  • Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 24 are presented.

  • Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
    The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 36 are presented.

  • Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 48 are presented.

  • Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters [ Time Frame: Week 60 ] [ Designated as safety issue: No ]
    The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 60 are presented.

  • Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
    The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 72 are presented.

  • Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters [ Time Frame: Week 84 ] [ Designated as safety issue: No ]
    The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 84 are presented.

  • Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
    The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 96 are presented.

  • Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters [ Time Frame: Week 108 ] [ Designated as safety issue: No ]
    The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 108 are presented.

  • Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters [ Time Frame: Week 120 ] [ Designated as safety issue: No ]
    The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 120 are presented.

  • Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters [ Time Frame: Week 132 ] [ Designated as safety issue: No ]
    The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 132 are presented.

  • Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters [ Time Frame: Week 144 ] [ Designated as safety issue: No ]
    The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 144 are presented.

  • Viral Load [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Baseline are presented.

  • Viral Load [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 4 are presented.

  • Viral Load [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 12 are presented.

  • Viral Load [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 24 are presented.

  • Viral Load [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
    The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 36 are presented.

  • Viral Load [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 48 are presented.

  • Viral Load [ Time Frame: Week 60 ] [ Designated as safety issue: No ]
    The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 60 are presented.

  • Viral Load [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
    The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 72 are presented.

  • Viral Load [ Time Frame: Week 84 ] [ Designated as safety issue: No ]
    The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 84 are presented.

  • Viral Load [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
    The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 96 are presented.

  • Viral Load [ Time Frame: Week 108 ] [ Designated as safety issue: No ]
    The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 108 are presented.

  • Viral Load [ Time Frame: Week 120 ] [ Designated as safety issue: No ]
    The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 120 are presented.

  • Viral Load [ Time Frame: Week 132 ] [ Designated as safety issue: No ]
    The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 132 are presented.

  • Viral Load [ Time Frame: Week 144 ] [ Designated as safety issue: No ]
    The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 144 are presented.

  • CD4 Cell Count [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Baseline are presented.

  • CD4 Cell Count [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 4 are presented.

  • CD4 Cell Count [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 12 are presented.

  • CD4 Cell Count [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 24 are presented.

  • CD4 Cell Count [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
    The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 36 are presented.

  • CD4 Cell Count [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 48 are presented.

  • CD4 Cell Count [ Time Frame: Week 60 ] [ Designated as safety issue: No ]
    The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 60 are presented.

  • CD4 Cell Count [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
    The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 72 are presented.

  • CD4 Cell Count [ Time Frame: Week 84 ] [ Designated as safety issue: No ]
    The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 84 are presented.

  • CD4 Cell Count [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
    The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 96 are presented.

  • CD4 Cell Count [ Time Frame: Week 108 ] [ Designated as safety issue: No ]
    The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 108 are presented.

  • CD4 Cell Count [ Time Frame: Week 120 ] [ Designated as safety issue: No ]
    The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 120 are presented.

  • CD4 Cell Count [ Time Frame: Week 132 ] [ Designated as safety issue: No ]
    The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 132 are presented.

  • CD4 Cell Count [ Time Frame: Week 144 ] [ Designated as safety issue: No ]
    The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 144 are presented.
Enrollment: 33
Study Start Date: May 2001
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
HIV-infected patients with hepatitis co-infection
HIV-infected patients with co-infections of Hepatitis B or Hepatitis C
 Drug: Lopinavir/Ritonavir (Kaletra)
3 capsules 2xdaily or 2 tablets 2xdaily Kaletra

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community sample, Human Immunodeficiency Virus-infected patients with Hepatitis B or C co-infections
Criteria

Inclusion Criteria:

  • Patients infected by HIV-1 and HBV or HCV
  • Age ≥18 years
  • Patients who were initiated on a LPV/r containing antiretroviral (ARV) regimen

Exclusion Criteria:

- Contraindications as described in SmPC (summary of product characteristics) at the time of prescription

  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: NCT01153269

Locations
Germany
Site Reference ID/Investigator# 27575
Berlin, Germany, 10243
Site Reference ID/Investigator# 27592
Berlin, Germany, 10961
Site Reference ID/Investigator# 27588
Dortmund, Germany, 44137
Site Reference ID/Investigator# 27583
Frankfurt, Germany, 60311
Site Reference ID/Investigator# 27587
Frankfurt, Germany, 60596
Site Reference ID/Investigator# 27607
Hamburg, Germany, 20099
Site Reference ID/Investigator# 5355
Krefeld, Germany, 47800
Site Reference ID/Investigator# 27604
Muenster, Germany, 48149
Sponsors and Collaborators
Abbott
Investigators
Study Director: Stefan Simianer, MD Abbott Germany, Medical Department
  More Information

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01153269     History of Changes
Other Study ID Numbers: KAL 1 HO 
Study First Received: February 26, 2010
Results First Received: November 16, 2011
Last Updated: November 16, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Abbott:
Human Immunodeficiency Virus
Co-infection with Hepatitis B or Hepatitis C
Tolerability
Effectiveness

Additional relevant MeSH terms:
Hepatitis
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Virus Diseases
Liver Diseases
Digestive System Diseases
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
 Slow Virus Diseases
Ritonavir
Lopinavir
HIV Protease Inhibitors
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

ClinicalTrials.gov processed this record on September 29, 2016