Human Immunodeficiency Virus-Infection Clinical Trial
Official title:
Long-term Effectiveness and Safety in Hepatitis-co-infected Patients
| Verified date | November 2011 |
| Source | Abbott |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Federal Institute for Drugs and Medical Devices |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 33 |
| Est. completion date | November 2010 |
| Est. primary completion date | November 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | Site Reference ID/Investigator# 27575 | Berlin | |
| Germany | Site Reference ID/Investigator# 27592 | Berlin | |
| Germany | Site Reference ID/Investigator# 27588 | Dortmund | |
| Germany | Site Reference ID/Investigator# 27583 | Frankfurt | |
| Germany | Site Reference ID/Investigator# 27587 | Frankfurt | |
| Germany | Site Reference ID/Investigator# 27607 | Hamburg | |
| Germany | Site Reference ID/Investigator# 5355 | Krefeld | |
| Germany | Site Reference ID/Investigator# 27604 | Muenster |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |