Clinical trial NCT01153269: Long-term Effectiveness and Safety in Hepatitis-co-infected Patients
Official title: Long-term Effectiveness and Safety in Hepatitis-co-infected Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus-Infection
Keywords: Human Immunodeficiency Virus
Co-infection with Hepatitis B or Hepatitis C
Tolerability
Effectiveness
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2010-06-30
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample, Human Immunodeficiency Virus-infected patients with Hepatitis B or C co-infections

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.


Eligibility 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

Primary outcomes:
measure: Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
timeFrame: Baseline
measure: Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
timeFrame: Week 4
measure: Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
timeFrame: Week 12
measure: Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
timeFrame: Week 24
measure: Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
timeFrame: Week 36
measure: Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
timeFrame: Week 48
measure: Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
timeFrame: Week 60
measure: Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
timeFrame: Week 72
measure: Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
timeFrame: Week 84
measure: Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
timeFrame: Week 96
measure: Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
timeFrame: Week 108
measure: Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
timeFrame: Week 120
measure: Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
timeFrame: Week 132
measure: Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
timeFrame: Week 144
measure: Viral Load
timeFrame: Baseline
measure: Viral Load
timeFrame: Week 4
measure: Viral Load
timeFrame: Week 12
measure: Viral Load
timeFrame: Week 24
measure: Viral Load
timeFrame: Week 36
measure: Viral Load
timeFrame: Week 48
measure: Viral Load
timeFrame: Week 60
measure: Viral Load
timeFrame: Week 72
measure: Viral Load
timeFrame: Week 84
measure: Viral Load
timeFrame: Week 96
measure: Viral Load
timeFrame: Week 108
measure: Viral Load
timeFrame: Week 120
measure: Viral Load
timeFrame: Week 132
measure: Viral Load
timeFrame: Week 144
measure: CD4 Cell Count
timeFrame: Baseline
measure: CD4 Cell Count
timeFrame: Week 4
measure: CD4 Cell Count
timeFrame: Week 12
measure: CD4 Cell Count
timeFrame: Week 24
measure: CD4 Cell Count
timeFrame: Week 36
measure: CD4 Cell Count
timeFrame: Week 48
measure: CD4 Cell Count
timeFrame: Week 60
measure: CD4 Cell Count
timeFrame: Week 72
measure: CD4 Cell Count
timeFrame: Week 84
measure: CD4 Cell Count
timeFrame: Week 96
measure: CD4 Cell Count
timeFrame: Week 108
measure: CD4 Cell Count
timeFrame: Week 120
measure: CD4 Cell Count
timeFrame: Week 132
measure: CD4 Cell Count
timeFrame: Week 144
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 27575
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 27592
city: Dortmund
country: Germany
facility: Site Reference ID/Investigator# 27588
city: Frankfurt
country: Germany
facility: Site Reference ID/Investigator# 27583
city: Frankfurt
country: Germany
facility: Site Reference ID/Investigator# 27587
city: Hamburg
country: Germany
facility: Site Reference ID/Investigator# 27607
city: Krefeld
country: Germany
facility: Site Reference ID/Investigator# 5355
city: Muenster
country: Germany
facility: Site Reference ID/Investigator# 27604
Study officials:
affiliation: Abbott Germany, Medical Department
name: Stefan Simianer, MD
role: STUDY_DIRECTOR
References: