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Long-term Effectiveness and Safety in Hepatitis-co-infected Patients
This study has been completed.
Sponsor:
Abbott
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01153269
First received: February 26, 2010
Last updated: November 16, 2011
Last verified: November 2011
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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:
Further study details as provided by Abbott:
Primary Outcome Measures:
- Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters [ Time Frame: Baseline ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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) |
| Sexes Eligible for Study: | All |
| 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
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 |
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 August 21, 2017