Long-term Effectiveness and Safety in Hepatitis-co-infected Patients
1 other identifier
observational
33
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2001
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2001
CompletedFirst Submitted
Initial submission to the registry
February 26, 2010
CompletedFirst Posted
Study publicly available on registry
June 30, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedResults Posted
Study results publicly available
December 19, 2011
CompletedDecember 19, 2011
November 1, 2011
9.5 years
February 26, 2010
November 16, 2011
November 16, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (42)
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
Study Arms (1)
HIV-infected patients with hepatitis co-infection
HIV-infected patients with co-infections of Hepatitis B or Hepatitis C
Interventions
3 capsules 2xdaily or 2 tablets 2xdaily Kaletra
Eligibility Criteria
Community sample, Human Immunodeficiency Virus-infected patients with Hepatitis B or C co-infections
You may qualify if:
- Patients infected by HIV-1 and HBV or HCV
- Age ≥18 years
- Patients who were initiated on a LPV/r containing antiretroviral (ARV) regimen
You may not qualify if:
- \- Contraindications as described in SmPC (summary of product characteristics) at the time of prescription
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (8)
Site Reference ID/Investigator# 27575
Berlin, 10243, Germany
Site Reference ID/Investigator# 27592
Berlin, 10961, Germany
Site Reference ID/Investigator# 27588
Dortmund, 44137, Germany
Site Reference ID/Investigator# 27583
Frankfurt, 60311, Germany
Site Reference ID/Investigator# 27587
Frankfurt, 60596, Germany
Site Reference ID/Investigator# 27607
Hamburg, 20099, Germany
Site Reference ID/Investigator# 5355
Krefeld, 47800, Germany
Site Reference ID/Investigator# 27604
Münster, 48149, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- Abbott
Study Officials
- STUDY DIRECTOR
Stefan Simianer, MD
Abbott Germany, Medical Department
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2010
First Posted
June 30, 2010
Study Start
May 1, 2001
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
December 19, 2011
Results First Posted
December 19, 2011
Record last verified: 2011-11