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CompletedNCT01153269Updated Dec 19, 2011Results posted

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

An observational study in Human Immunodeficiency Virus-Infection, sponsored by Abbott. Completed at 8 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-12-19.

Sponsored by Abbott · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
33
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Human Immunodeficiency Virus-Infection

Keywords

  • Human Immunodeficiency Virus
  • Co-infection with Hepatitis B or Hepatitis C
  • Tolerability
  • Effectiveness
03

In context

Acquired Immunodeficiency Syndrome

2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.

This study's enrollment of 33 is below the median of 236 across 355 observational studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

Abbott is the lead sponsor of 350 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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

Exclusion Criteria:

  • Contraindications as described in SmPC (summary of product characteristics) at the time of prescription
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
33 participants (actual)

Groups and cohorts

  • HIV-infected patients with hepatitis co-infection

    HIV-infected patients with co-infections of Hepatitis B or Hepatitis C

    Drug: Lopinavir/Ritonavir (Kaletra)

Interventions

  • DrugLopinavir/Ritonavir (Kaletra)

    3 capsules 2xdaily or 2 tablets 2xdaily Kaletra

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: Week 4

  3. 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.

    Time frame: Week 12

  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 24 are presented.

    Time frame: Week 24

  5. 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.

    Time frame: Week 36

  6. 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.

    Time frame: Week 48

  7. 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.

    Time frame: Week 60

  8. 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.

    Time frame: Week 72

  9. 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.

    Time frame: Week 84

  10. 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.

    Time frame: Week 96

  11. 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.

    Time frame: Week 108

  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 120 are presented.

    Time frame: Week 120

  13. 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.

    Time frame: Week 132

  14. 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.

    Time frame: Week 144

  15. 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.

    Time frame: Baseline

  16. 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.

    Time frame: Week 4

  17. 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.

    Time frame: Week 12

  18. 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.

    Time frame: Week 24

  19. 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.

    Time frame: Week 36

  20. 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.

    Time frame: Week 48

  21. 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.

    Time frame: Week 60

  22. 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.

    Time frame: Week 72

  23. 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.

    Time frame: Week 84

  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 96 are presented.

    Time frame: Week 96

  25. 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.

    Time frame: Week 108

  26. 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.

    Time frame: Week 120

  27. 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.

    Time frame: Week 132

  28. 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.

    Time frame: Week 144

  29. 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.

    Time frame: Baseline

  30. 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.

    Time frame: Week 4

  31. 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.

    Time frame: Week 12

  32. 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.

    Time frame: Week 24

  33. 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.

    Time frame: Week 36

  34. 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.

    Time frame: Week 48

  35. 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.

    Time frame: Week 60

  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 72 are presented.

    Time frame: Week 72

  37. 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.

    Time frame: Week 84

  38. 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.

    Time frame: Week 96

  39. 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.

    Time frame: Week 108

  40. 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.

    Time frame: Week 120

  41. 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.

    Time frame: Week 132

  42. 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.

    Time frame: Week 144

07

Results

Posted Dec 19, 2011

Participant flow

Participant flow — Overall Study
MilestoneHIV-infected Participants With Hepatitis Co-infection
Started33
Participants analyzed33
Completed31
Not completed2
Withdrew: Withdrawal by subject1
Withdrew: Antiretroviral therapy break1

Outcome measures

PrimaryAspartate 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.

Time frame:
Baseline
Reported as:
Mean · U/liter
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
U/literHIV-infected Participants With Hepatitis Co-infection: ASTHIV-infected Participants With Hepatitis Co-infection: ALT
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters64 ± 6369 ± 88
PrimaryAspartate 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.

Time frame:
Week 4
Reported as:
Mean · U/liter
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
U/literHIV-infected Participants With Hepatitis Co-infection: ASTHIV-infected Participants With Hepatitis Co-infection: ALT
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters85 ± 9685 ± 86
PrimaryAspartate 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.

Time frame:
Week 12
Reported as:
Mean · U/liter
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
U/literHIV-infected Participants With Hepatitis Co-infection: ASTHIV-infected Participants With Hepatitis Co-infection: ALT
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters69 ± 5085 ± 79
PrimaryAspartate 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.

Time frame:
Week 24
Reported as:
Mean · U/liter
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
U/literHIV-infected Participants With Hepatitis Co-infection: ASTHIV-infected Participants With Hepatitis Co-infection: ALT
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters78 ± 9497 ± 134
PrimaryAspartate 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.

Time frame:
Week 36
Reported as:
Mean · U/liter
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
U/literHIV-infected Participants With Hepatitis Co-infection: ASTHIV-infected Participants With Hepatitis Co-infection: ALT
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters54 ± 3375 ± 87
PrimaryAspartate 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.

Time frame:
Week 48
Reported as:
Mean · U/liter
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
U/literHIV-infected Participants With Hepatitis Co-infection: ASTHIV-infected Participants With Hepatitis Co-infection: ALT
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters60 ± 4179 ± 92
PrimaryAspartate 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.

Time frame:
Week 60
Reported as:
Mean · U/liter
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
U/literHIV-infected Participants With Hepatitis Co-infection: ASTHIV-infected Participants With Hepatitis Co-infection: ALT
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters55 ± 3859 ± 50
PrimaryAspartate 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.

Time frame:
Week 72
Reported as:
Mean · U/liter
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
U/literHIV-infected Participants With Hepatitis Co-infection: ASTHIV-infected Participants With Hepatitis Co-infection: ALT
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters51 ± 3650 ± 35
PrimaryAspartate 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.

Time frame:
Week 84
Reported as:
Mean · U/liter
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
U/literHIV-infected Participants With Hepatitis Co-infection: ASTHIV-infected Participants With Hepatitis Co-infection: ALT
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters55 ± 3349 ± 27
PrimaryAspartate 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.

Time frame:
Week 96
Reported as:
Mean · U/liter
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
U/literHIV-infected Participants With Hepatitis Co-infection: ASTHIV-infected Participants With Hepatitis Co-infection: ALT
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters63 ± 4463 ± 45
PrimaryAspartate 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.

Time frame:
Week 108
Reported as:
Mean · U/liter
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
U/literHIV-infected Participants With Hepatitis Co-infection: ASTHIV-infected Participants With Hepatitis Co-infection: ALT
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters47 ± 1943 ± 20
PrimaryAspartate 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.

Time frame:
Week 120
Reported as:
Mean · U/liter
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
U/literHIV-infected Participants With Hepatitis Co-infection: ASTHIV-infected Participants With Hepatitis Co-infection: ALT
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters56 ± 3065 ± 39
PrimaryAspartate 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.

Time frame:
Week 132
Reported as:
Mean · U/liter
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
U/literHIV-infected Participants With Hepatitis Co-infection: ASTHIV-infected Participants With Hepatitis Co-infection: ALT
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters49 ± 2451 ± 31
PrimaryAspartate 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.

Time frame:
Week 144
Reported as:
Mean · U/liter
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
U/literHIV-infected Participants With Hepatitis Co-infection: ASTHIV-infected Participants With Hepatitis Co-infection: ALT
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters52 ± 2853 ± 36
PrimaryViral 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.

Time frame:
Baseline
Reported as:
Mean · log10 copies/mL
Viral Load
log10 copies/mLHIV-infected Participants With Hepatitis Co-infection
Viral Load3.9 ± 1.4
PrimaryViral 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.

Time frame:
Week 4
Reported as:
Mean · log10 copies/mL
Viral Load
log10 copies/mLHIV-infected Participants With Hepatitis Co-infection
Viral Load2.5 ± 0.8
PrimaryViral 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.

Time frame:
Week 12
Reported as:
Mean · log10 copies/mL
Viral Load
log10 copies/mLHIV-infected Participants With Hepatitis Co-infection
Viral Load2.0 ± 0.5
PrimaryViral 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.

Time frame:
Week 24
Reported as:
Mean · log10 copies/mL
Viral Load
log10 copies/mLHIV-infected Participants With Hepatitis Co-infection
Viral Load1.7 ± 0.4
PrimaryViral 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.

Time frame:
Week 36
Reported as:
Mean · log10 copies/mL
Viral Load
log10 copies/mLHIV-infected Participants With Hepatitis Co-infection
Viral Load1.6 ± 0.2
PrimaryViral 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.

Time frame:
Week 48
Reported as:
Mean · log10 copies/mL
Viral Load
log10 copies/mLHIV-infected Participants With Hepatitis Co-infection
Viral Load1.7 ± 0.3
PrimaryViral 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.

Time frame:
Week 60
Reported as:
Mean · log10 copies/mL
Viral Load
log10 copies/mLHIV-infected Participants With Hepatitis Co-infection
Viral Load1.7 ± 0.4
PrimaryViral 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.

Time frame:
Week 72
Reported as:
Mean · log10 copies/mL
Viral Load
log10 copies/mLHIV-infected Participants With Hepatitis Co-infection
Viral Load1.6 ± 0.2
PrimaryViral 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.

Time frame:
Week 84
Reported as:
Mean · log10 copies/mL
Viral Load
log10 copies/mLHIV-infected Participants With Hepatitis Co-infection
Viral Load1.5 ± 0.3
PrimaryViral 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.

Time frame:
Week 96
Reported as:
Mean · log10 copies/mL
Viral Load
log10 copies/mLHIV-infected Participants With Hepatitis Co-infection
Viral Load1.6 ± 0.3
PrimaryViral 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.

Time frame:
Week 108
Reported as:
Mean · log10 copies/mL
Viral Load
log10 copies/mLHIV-infected Participants With Hepatitis Co-infection
Viral Load1.6 ± 0.4
PrimaryViral 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.

Time frame:
Week 120
Reported as:
Mean · log10 copies/mL
Viral Load
log10 copies/mLHIV-infected Participants With Hepatitis Co-infection
Viral Load1.6 ± 0.4
PrimaryViral 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.

Time frame:
Week 132
Reported as:
Mean · log10 copies/mL
Viral Load
log10 copies/mLHIV-infected Participants With Hepatitis Co-infection
Viral Load1.6 ± 0.3
PrimaryViral 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.

Time frame:
Week 144
Reported as:
Mean · log10 copies/mL
Viral Load
log10 copies/mLHIV-infected Participants With Hepatitis Co-infection
Viral Load1.5 ± 0.2
PrimaryCD4 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.

Time frame:
Baseline
Reported as:
Mean · CD4+ cells/μL
CD4 Cell Count
CD4+ cells/μLHIV-infected Participants With Hepatitis Co-infection
CD4 Cell Count288 ± 192
PrimaryCD4 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.

Time frame:
Week 4
Reported as:
Mean · CD4+ cells/μL
CD4 Cell Count
CD4+ cells/μLHIV-infected Participants With Hepatitis Co-infection
CD4 Cell Count350 ± 165
PrimaryCD4 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.

Time frame:
Week 12
Reported as:
Mean · CD4+ cells/μL
CD4 Cell Count
CD4+ cells/μLHIV-infected Participants With Hepatitis Co-infection
CD4 Cell Count378 ± 204
PrimaryCD4 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.

Time frame:
Week 24
Reported as:
Mean · CD4+ cells/μL
CD4 Cell Count
CD4+ cells/μLHIV-infected Participants With Hepatitis Co-infection
CD4 Cell Count383 ± 211
PrimaryCD4 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.

Time frame:
Week 36
Reported as:
Mean · CD4+ cells/μL
CD4 Cell Count
CD4+ cells/μLHIV-infected Participants With Hepatitis Co-infection
CD4 Cell Count408 ± 187
PrimaryCD4 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.

Time frame:
Week 48
Reported as:
Mean · CD4+ cells/μL
CD4 Cell Count
CD4+ cells/μLHIV-infected Participants With Hepatitis Co-infection
CD4 Cell Count402 ± 239
PrimaryCD4 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.

Time frame:
Week 60
Reported as:
Mean · CD4+ cells/μL
CD4 Cell Count
CD4+ cells/μLHIV-infected Participants With Hepatitis Co-infection
CD4 Cell Count424 ± 193
PrimaryCD4 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.

Time frame:
Week 72
Reported as:
Mean · CD4+ cells/μL
CD4 Cell Count
CD4+ cells/μLHIV-infected Participants With Hepatitis Co-infection
CD4 Cell Count431 ± 235
PrimaryCD4 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.

Time frame:
Week 84
Reported as:
Mean · CD4+ cells/μL
CD4 Cell Count
CD4+ cells/μLHIV-infected Participants With Hepatitis Co-infection
CD4 Cell Count405 ± 170
PrimaryCD4 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.

Time frame:
Week 96
Reported as:
Mean · CD4+ cells/μL
CD4 Cell Count
CD4+ cells/μLHIV-infected Participants With Hepatitis Co-infection
CD4 Cell Count503 ± 237
PrimaryCD4 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.

Time frame:
Week 108
Reported as:
Mean · CD4+ cells/μL
CD4 Cell Count
CD4+ cells/μLHIV-infected Participants With Hepatitis Co-infection
CD4 Cell Count581 ± 303
PrimaryCD4 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.

Time frame:
Week 120
Reported as:
Mean · CD4+ cells/μL
CD4 Cell Count
CD4+ cells/μLHIV-infected Participants With Hepatitis Co-infection
CD4 Cell Count565 ± 256
PrimaryCD4 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.

Time frame:
Week 132
Reported as:
Mean · CD4+ cells/μL
CD4 Cell Count
CD4+ cells/μLHIV-infected Participants With Hepatitis Co-infection
CD4 Cell Count502 ± 259
PrimaryCD4 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.

Time frame:
Week 144
Reported as:
Mean · CD4+ cells/μL
CD4 Cell Count
CD4+ cells/μLHIV-infected Participants With Hepatitis Co-infection
CD4 Cell Count525 ± 226

Adverse events

Collected over Investigators were instructed to report adverse events throughout the study (up to 3 years).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
HIV-infected Participants With Hepatitis Co-infection—0/33 (0%)1/33 (3%)
Most frequent other events
Most frequent other events
EventHIV-infected Participants With Hepatitis Co-infection
antiviral drug level above therapeuticInvestigations1/33

Baseline characteristics

Age Continuous
Age Continuous(years)HIV-infected Participants With Hepatitis Co-infection
Mean42.4 ± 7.1
Sex: Female, Male
Sex: Female, Male(Participants)HIV-infected Participants With Hepatitis Co-infection
Female8
Male25
Region of Enrollment
Region of Enrollment(participants)HIV-infected Participants With Hepatitis Co-infection
Germany33
Hepatitis Co-infection
Hepatitis Co-infection(participants)HIV-infected Participants With Hepatitis Co-infection
Chronic hepatitis B9
Chronic hepatitis C24
Duration of HIV infection
Duration of HIV infection(years)HIV-infected Participants With Hepatitis Co-infection
Mean9.7 ± 7.4
08

Study locations

8 sites
  • 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
    Muenster, 48149, Germany
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01153269
Lead sponsor
Abbott
Responsible party
Sponsor
First posted
Jun 30, 2010
Start date
May 2001
Primary completion
Nov 2010
Completion
Nov 2010
Results posted
Dec 19, 2011
Last update
Dec 19, 2011

Study contacts

Stefan Simianer, MD
study director · Abbott Germany, Medical Department

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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