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

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ClinicalTrials.gov Identifier: NCT01153269
Recruitment Status : Completed
First Posted : June 30, 2010
Results First Posted : December 19, 2011
Last Update Posted : December 19, 2011
Sponsor:
Information provided by (Responsible Party):
Abbott

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Human Immunodeficiency Virus-Infection
Intervention Drug: Lopinavir/Ritonavir (Kaletra)
Enrollment 33

Recruitment Details  
Pre-assignment Details  
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection
Hide Arm/Group Description HIV-infected participants with co-infections of hepatitis B or hepatitis C.
Period Title: Overall Study
Started 33
Participants Analyzed 33
Completed 31
Not Completed 2
Reason Not Completed
Withdrawal by Subject             1
Antiretroviral therapy break             1
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection
Hide Arm/Group Description HIV-infected participants with co-infections of hepatitis B or hepatitis C.
Overall Number of Baseline Participants 33
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants
42.4  (7.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Female
8
  24.2%
Male
25
  75.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 33 participants
33
Hepatitis Co-infection   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants
Chronic hepatitis B 9
Chronic hepatitis C 24
[1]
Measure Description: The number of participants with hepatitis B or hepatitis C co-infection.
Duration of HIV infection   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants
9.7  (7.4)
[1]
Measure Description: How long participants had been diagnosed with HIV infection at Baseline. Based on 32 participants.
1.Primary Outcome
Title Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with aspartate aminotransferase and alanine aminotransferase results at Baseline.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection: AST HIV-infected Participants With Hepatitis Co-infection: ALT
Hide Arm/Group Description:
Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Overall Number of Participants Analyzed 25 24
Mean (Standard Deviation)
Unit of Measure: U/liter
64  (63) 69  (88)
2.Primary Outcome
Title Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with aspartate aminotransferase and alanine aminotransferase results at Week 4.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection: AST HIV-infected Participants With Hepatitis Co-infection: ALT
Hide Arm/Group Description:
Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: U/liter
85  (96) 85  (86)
3.Primary Outcome
Title Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with aspartate aminotransferase and alanine aminotransferase results at Week 12.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection: AST HIV-infected Participants With Hepatitis Co-infection: ALT
Hide Arm/Group Description:
Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Overall Number of Participants Analyzed 23 24
Mean (Standard Deviation)
Unit of Measure: U/liter
69  (50) 85  (79)
4.Primary Outcome
Title Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with aspartate aminotransferase and alanine aminotransferase results at Week 24.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection: AST HIV-infected Participants With Hepatitis Co-infection: ALT
Hide Arm/Group Description:
Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: U/liter
78  (94) 97  (134)
5.Primary Outcome
Title Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with aspartate aminotransferase and alanine aminotransferase results at Week 36.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection: AST HIV-infected Participants With Hepatitis Co-infection: ALT
Hide Arm/Group Description:
Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: U/liter
54  (33) 75  (87)
6.Primary Outcome
Title Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with aspartate aminotransferase and alanine aminotransferase results at Week 48.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection: AST HIV-infected Participants With Hepatitis Co-infection: ALT
Hide Arm/Group Description:
Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: U/liter
60  (41) 79  (92)
7.Primary Outcome
Title Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with aspartate aminotransferase and alanine aminotransferase results at Week 60.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection: AST HIV-infected Participants With Hepatitis Co-infection: ALT
Hide Arm/Group Description:
Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: U/liter
55  (38) 59  (50)
8.Primary Outcome
Title Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with aspartate aminotransferase and alanine aminotransferase results at Week 72.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection: AST HIV-infected Participants With Hepatitis Co-infection: ALT
Hide Arm/Group Description:
Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: U/liter
51  (36) 50  (35)
9.Primary Outcome
Title Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with aspartate aminotransferase and alanine aminotransferase results at Week 84.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection: AST HIV-infected Participants With Hepatitis Co-infection: ALT
Hide Arm/Group Description:
Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Overall Number of Participants Analyzed 17 18
Mean (Standard Deviation)
Unit of Measure: U/liter
55  (33) 49  (27)
10.Primary Outcome
Title Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with aspartate aminotransferase and alanine aminotransferase results at Week 96.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection: AST HIV-infected Participants With Hepatitis Co-infection: ALT
Hide Arm/Group Description:
Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: U/liter
63  (44) 63  (45)
11.Primary Outcome
Title Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with aspartate aminotransferase and alanine aminotransferase results at Week 108.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection: AST HIV-infected Participants With Hepatitis Co-infection: ALT
Hide Arm/Group Description:
Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Overall Number of Participants Analyzed 18 19
Mean (Standard Deviation)
Unit of Measure: U/liter
47  (19) 43  (20)
12.Primary Outcome
Title Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with aspartate aminotransferase and alanine aminotransferase results at Week 120.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection: AST HIV-infected Participants With Hepatitis Co-infection: ALT
Hide Arm/Group Description:
Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: U/liter
56  (30) 65  (39)
13.Primary Outcome
Title Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with aspartate aminotransferase and alanine aminotransferase results at Week 132.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection: AST HIV-infected Participants With Hepatitis Co-infection: ALT
Hide Arm/Group Description:
Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: U/liter
49  (24) 51  (31)
14.Primary Outcome
Title Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with aspartate aminotransferase and alanine aminotransferase results at Week 144.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection: AST HIV-infected Participants With Hepatitis Co-infection: ALT
Hide Arm/Group Description:
Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: U/liter
52  (28) 53  (36)
15.Primary Outcome
Title Viral Load
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with HIV-1 RNA results at Baseline.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection
Hide Arm/Group Description:
HIV-infected participants with co-infections of hepatitis B or hepatitis C
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
3.9  (1.4)
16.Primary Outcome
Title Viral Load
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with HIV-1 RNA results at Week 4.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection
Hide Arm/Group Description:
HIV-infected participants with co-infections of hepatitis B or hepatitis C.
Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
2.5  (0.8)
17.Primary Outcome
Title Viral Load
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with HIV-1 RNA results at Week 12.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection
Hide Arm/Group Description:
HIV-infected participants with co-infections of hepatitis B or hepatitis C.
Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
2.0  (0.5)
18.Primary Outcome
Title Viral Load
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with HIV-1 RNA results at Week 24.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection
Hide Arm/Group Description:
HIV-infected participants with co-infections of hepatitis B or hepatitis C.
Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
1.7  (0.4)
19.Primary Outcome
Title Viral Load
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with HIV-1 RNA results at Week 36.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection
Hide Arm/Group Description:
HIV-infected participants with co-infections of hepatitis B or hepatitis C
Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
1.6  (0.2)
20.Primary Outcome
Title Viral Load
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with HIV-1 RNA results at Week 48.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection
Hide Arm/Group Description:
HIV-infected participants with co-infections of hepatitis B or hepatitis C.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
1.7  (0.3)
21.Primary Outcome
Title Viral Load
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with HIV-1 RNA results at Week 60.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection
Hide Arm/Group Description:
HIV-infected participants with co-infections of hepatitis B or hepatitis C.
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
1.7  (0.4)
22.Primary Outcome
Title Viral Load
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with HIV-1 RNA results at Week 72.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection
Hide Arm/Group Description:
HIV-infected participants with co-infections of hepatitis B or hepatitis C
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
1.6  (0.2)
23.Primary Outcome
Title Viral Load
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with HIV-1 RNA results at Week 84.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection
Hide Arm/Group Description:
HIV-infected participants with co-infections of hepatitis B or hepatitis C.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
1.5  (0.3)
24.Primary Outcome
Title Viral Load
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with HIV-1 RNA results at Week 96.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection
Hide Arm/Group Description:
HIV-infected participants with co-infections of hepatitis B or hepatitis C.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
1.6  (0.3)
25.Primary Outcome
Title Viral Load
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with HIV-1 RNA results at Week 108.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection
Hide Arm/Group Description:
HIV-infected participants with co-infections of hepatitis B or hepatitis C
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
1.6  (0.4)
26.Primary Outcome
Title Viral Load
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with HIV-1 RNA results at Week 120.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection
Hide Arm/Group Description:
HIV-infected participants with co-infections of hepatitis B or hepatitis C
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
1.6  (0.4)
27.Primary Outcome
Title Viral Load
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with HIV-1 RNA results at Week 132.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection
Hide Arm/Group Description:
HIV-infected participants with co-infections of hepatitis B or hepatitis C.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
1.6  (0.3)
28.Primary Outcome
Title Viral Load
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with HIV-1 RNA results at Week 144.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection
Hide Arm/Group Description:
HIV-infected participants with co-infections of hepatitis B or hepatitis C.
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
1.5  (0.2)
29.Primary Outcome
Title CD4 Cell Count
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with CD4+ cell count measurements at Baseline are included.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection
Hide Arm/Group Description:
HIV-infected participants with co-infections of hepatitis B or hepatitis C.
Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: CD4+ cells/μL
288  (192)
30.Primary Outcome
Title CD4 Cell Count
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with CD4+ cell count measurements at Week 4 are included.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection
Hide Arm/Group Description:
HIV-infected participants with co-infections of hepatitis B or hepatitis C
Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: CD4+ cells/μL
350  (165)
31.Primary Outcome
Title CD4 Cell Count
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with CD4+ cell count measurements at Week 12 are included.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection
Hide Arm/Group Description:
HIV-infected participants with co-infections of hepatitis B or hepatitis C.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: CD4+ cells/μL
378  (204)
32.Primary Outcome
Title CD4 Cell Count
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with CD4+ cell count measurements at Week 24 are included.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection
Hide Arm/Group Description:
HIV-infected participants with co-infections of hepatitis B or hepatitis C.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: CD4+ cells/μL
383  (211)
33.Primary Outcome
Title CD4 Cell Count
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with CD4+ cell count measurements at Week 36 are included.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection
Hide Arm/Group Description:
HIV-infected participants with co-infections of hepatitis B or hepatitis C.
Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: CD4+ cells/μL
408  (187)
34.Primary Outcome
Title CD4 Cell Count
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with CD4+ cell count measurements at Week 48 are included.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection
Hide Arm/Group Description:
HIV-infected participants with co-infections of hepatitis B or hepatitis C.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: CD4+ cells/μL
402  (239)
35.Primary Outcome
Title CD4 Cell Count
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with CD4+ cell count measurements at Baseline are included.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection
Hide Arm/Group Description:
HIV-infected participants with co-infections of hepatitis B or hepatitis C.
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: CD4+ cells/μL
424  (193)
36.Primary Outcome
Title CD4 Cell Count
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with CD4+ cell count measurements at Week 72 are included.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection
Hide Arm/Group Description:
HIV-infected participants with co-infections of hepatitis B or hepatitis C.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: CD4+ cells/μL
431  (235)
37.Primary Outcome
Title CD4 Cell Count
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with CD4+ cell count measurements at Week 84 are included.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection
Hide Arm/Group Description:
HIV-infected participants with co-infections of hepatitis B or hepatitis C.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: CD4+ cells/μL
405  (170)
38.Primary Outcome
Title CD4 Cell Count
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with CD4+ cell count measurements at Week 96 are included.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection
Hide Arm/Group Description:
HIV-infected participants with co-infections of hepatitis B or hepatitis C.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: CD4+ cells/μL
503  (237)
39.Primary Outcome
Title CD4 Cell Count
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with CD4+ cell count measurements at Week 108 are included.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection
Hide Arm/Group Description:
HIV-infected participants with co-infections of hepatitis B or hepatitis C.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: CD4+ cells/μL
581  (303)
40.Primary Outcome
Title CD4 Cell Count
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with CD4+ cell count measurements at Week 120 are included.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection
Hide Arm/Group Description:
HIV-infected participants with co-infections of hepatitis B or hepatitis C.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: CD4+ cells/μL
565  (256)
41.Primary Outcome
Title CD4 Cell Count
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with CD4+ cell count measurements at Week 132 are included.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection
Hide Arm/Group Description:
HIV-infected participants with co-infections of hepatitis B or hepatitis C.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: CD4+ cells/μL
502  (259)
42.Primary Outcome
Title CD4 Cell Count
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with CD4+ cell count measurements at Week 144 are included.
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection
Hide Arm/Group Description:
HIV-infected participants with co-infections of hepatitis B or hepatitis C
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: CD4+ cells/μL
525  (226)
Time Frame Investigators were instructed to report adverse events throughout the study (up to 3 years).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title HIV-infected Participants With Hepatitis Co-infection
Hide Arm/Group Description HIV-infected participants with co-infections of hepatitis B or hepatitis C.
All-Cause Mortality
HIV-infected Participants With Hepatitis Co-infection
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
HIV-infected Participants With Hepatitis Co-infection
Affected / at Risk (%) # Events
Total   0/33 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
HIV-infected Participants With Hepatitis Co-infection
Affected / at Risk (%) # Events
Total   1/33 (3.03%)    
Investigations   
antiviral drug level above therapeutic * 1  1/33 (3.03%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Raw (uncoded) terms
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title: Global Medical Services
Organization: Abbott
Phone: 1-800-633-9110
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