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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01153269

First Posted: June 30, 2010

Last Update Posted: December 19, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Abbott

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:

MedlinePlus related topics: HIV/AIDS Hepatitis Hepatitis A

Drug Information available for: Ritonavir Lopinavir

U.S. FDA Resources

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted:	February 26, 2010
First Posted:	June 30, 2010
Results First Submitted:	November 16, 2011
Results First Posted:	December 19, 2011
Last Update Posted:	December 19, 2011
Last Verified:	November 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

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