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OpenTrials
Completed

NCT Number: NCT01153269

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

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.

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Key information

Conditions

Human Immunodeficiency Virus-Infection Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Genital Diseases HIV Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site Reference ID/Investigator# 27575, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lopinavir/ritonavir (Kaletra)

Drug

3 capsules 2xdaily or 2 tablets 2xdaily Kaletra

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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.

  36. 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.

  37. 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.

  38. 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.

  39. 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.

  40. 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.

  41. 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.

  42. 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.

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Important dates

Study start
2001
Primary completion
2010
Study completion
2010
First posted
Jun 30, 2010
Registry last updated
Dec 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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