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

Study Overview
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Brief Summary
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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.

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

Conditions
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Human Immunodeficiency Virus-Infection

Intervention / Treatment
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* Drug: Lopinavir/Ritonavir (Kaletra)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV-infected patients with hepatitis co-infection<br>HIV-infected patients with co-infections of Hepatitis B or Hepatitis C | Drug: Lopinavir/Ritonavir (Kaletra)<br>* 3 capsules 2xdaily or 2 tablets 2xdaily Kaletra<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 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. | Baseline | 
| Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 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. | Week 4 | 
| Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 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. | Week 12 | 
| Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 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. | Week 24 | 
| Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 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. | Week 36 | 
| Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 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. | Week 48 | 
| Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 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. | Week 60 | 
| Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 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. | Week 72 | 
| Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 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. | Week 84 | 
| Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 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. | Week 96 | 
| Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 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. | Week 108 | 
| Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 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. | Week 120 | 
| Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 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. | Week 132 | 
| Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 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. | Week 144 | 
| Viral Load | 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. | Baseline | 
| Viral Load | 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. | Week 4 | 
| Viral Load | 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. | Week 12 | 
| Viral Load | 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. | Week 24 | 
| Viral Load | 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. | Week 36 | 
| Viral Load | 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. | Week 48 | 
| Viral Load | 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. | Week 60 | 
| Viral Load | 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. | Week 72 | 
| Viral Load | 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. | Week 84 | 
| Viral Load | 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. | Week 96 | 
| Viral Load | 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. | Week 108 | 
| Viral Load | 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. | Week 120 | 
| Viral Load | 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. | Week 132 | 
| Viral Load | 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. | Week 144 | 
| CD4 Cell Count | 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. | Baseline | 
| CD4 Cell Count | 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. | Week 4 | 
| CD4 Cell Count | 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. | Week 12 | 
| CD4 Cell Count | 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. | Week 24 | 
| CD4 Cell Count | 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. | Week 36 | 
| CD4 Cell Count | 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. | Week 48 | 
| CD4 Cell Count | 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. | Week 60 | 
| CD4 Cell Count | 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. | Week 72 | 
| CD4 Cell Count | 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. | Week 84 | 
| CD4 Cell Count | 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. | Week 96 | 
| CD4 Cell Count | 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. | Week 108 | 
| CD4 Cell Count | 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. | Week 120 | 
| CD4 Cell Count | 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. | Week 132 | 
| CD4 Cell Count | 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. | Week 144 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human Immunodeficiency Virus, Co-infection with Hepatitis B or Hepatitis C, Tolerability, Effectiveness