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

February 26, 2010
November 16, 2011
May 2001
November 2010   (final data collection date for primary outcome measure)
  • 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.
  • Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) parameters [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) parameters [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) parameters [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) parameters [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) parameters [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
  • Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) parameters [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) parameters [ Time Frame: Week 60 ] [ Designated as safety issue: No ]
  • Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) parameters [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
  • Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) parameters [ Time Frame: Week 84 ] [ Designated as safety issue: No ]
  • Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) parameters [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) parameters [ Time Frame: Week 108 ] [ Designated as safety issue: No ]
  • Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) parameters [ Time Frame: Week 120 ] [ Designated as safety issue: No ]
  • Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) parameters [ Time Frame: Week 132 ] [ Designated as safety issue: No ]
  • Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) parameters [ Time Frame: Week 144 ] [ Designated as safety issue: No ]
  • Viral load [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Viral load [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Viral load [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Viral load [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Viral load [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
  • Viral load [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Viral load [ Time Frame: Week 60 ] [ Designated as safety issue: No ]
  • Viral load [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
  • Viral load [ Time Frame: Week 84 ] [ Designated as safety issue: No ]
  • Viral load [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Viral load [ Time Frame: Week 108 ] [ Designated as safety issue: No ]
  • Viral load [ Time Frame: Week 120 ] [ Designated as safety issue: No ]
  • Viral load [ Time Frame: Week 132 ] [ Designated as safety issue: No ]
  • Viral load [ Time Frame: Week 144 ] [ Designated as safety issue: No ]
  • CD4 cell count [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • CD4 cell count [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • CD4 cell count [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • CD4 cell count [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • CD4 cell count [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
  • CD4 cell count [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • CD4 cell count [ Time Frame: Week 60 ] [ Designated as safety issue: No ]
  • CD4 cell count [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
  • CD4 cell count [ Time Frame: Week 84 ] [ Designated as safety issue: No ]
  • CD4 cell count [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • CD4 cell count [ Time Frame: Week 108 ] [ Designated as safety issue: No ]
  • CD4 cell count [ Time Frame: Week 120 ] [ Designated as safety issue: No ]
  • CD4 cell count [ Time Frame: Week 132 ] [ Designated as safety issue: No ]
  • CD4 cell count [ Time Frame: Week 144 ] [ Designated as safety issue: No ]
  • Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) parameters [ Time Frame: Week 156 ] [ Designated as safety issue: No ]
  • Viral load [ Time Frame: Week 156 ] [ Designated as safety issue: No ]
  • CD4 cell count [ Time Frame: Week 156 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01153269 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Long-term Effectiveness and Safety in Hepatitis-co-infected Patients
Long-term Effectiveness and Safety in Hepatitis-co-infected Patients

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Community sample, Human Immunodeficiency Virus-infected patients with Hepatitis B or C co-infections

Human Immunodeficiency Virus-Infection
Drug: Lopinavir/Ritonavir (Kaletra)
3 capsules 2xdaily or 2 tablets 2xdaily Kaletra
HIV-infected patients with hepatitis co-infection
HIV-infected patients with co-infections of Hepatitis B or Hepatitis C
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.
 
Completed
33
November 2010
November 2010   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01153269
KAL 1 HO
No
Abbott
Abbott
Not Provided
Study Director: Stefan Simianer, MD Abbott Germany, Medical Department
Abbott
November 2011

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