Trial Outcomes & Findings for Long-term Effectiveness and Safety in Hepatitis-co-infected Patients (NCT NCT01153269)

NCT ID: NCT01153269

Last Updated: 2011-12-19

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 33 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2011-12-19

Participant Flow

Participant milestones

Measure	HIV-infected Participants With Hepatitis Co-infection HIV-infected participants with co-infections of hepatitis B or hepatitis C.
Overall Study STARTED	33
Overall Study Participants Analyzed	33
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	HIV-infected Participants With Hepatitis Co-infection HIV-infected participants with co-infections of hepatitis B or hepatitis C.
Overall Study Withdrawal by Subject	1
Overall Study Antiretroviral therapy break	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	HIV-infected Participants With Hepatitis Co-infection n=33 Participants HIV-infected participants with co-infections of hepatitis B or hepatitis C.
Age Continuous	42.4 years STANDARD_DEVIATION 7.1 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Region of Enrollment Germany	33 participants n=5 Participants
Hepatitis Co-infection Chronic hepatitis B	9 participants n=5 Participants
Hepatitis Co-infection Chronic hepatitis C	24 participants n=5 Participants
Duration of HIV infection	9.7 years STANDARD_DEVIATION 7.4 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Participants with aspartate aminotransferase and alanine aminotransferase results at 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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=25 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT n=24 Participants Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters	64 U/liter Standard Deviation 63	69 U/liter Standard Deviation 88

PRIMARY outcome

Timeframe: Week 4

Population: Participants with aspartate aminotransferase and alanine aminotransferase results at 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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=26 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT n=26 Participants Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters	85 U/liter Standard Deviation 96	85 U/liter Standard Deviation 86

PRIMARY outcome

Timeframe: Week 12

Population: Participants with aspartate aminotransferase and alanine aminotransferase results at 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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=23 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT n=24 Participants Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters	69 U/liter Standard Deviation 50	85 U/liter Standard Deviation 79

PRIMARY outcome

Timeframe: Week 24

Population: Participants with aspartate aminotransferase and alanine aminotransferase results at 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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=23 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT n=23 Participants Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters	78 U/liter Standard Deviation 94	97 U/liter Standard Deviation 134

PRIMARY outcome

Timeframe: Week 36

Population: Participants with aspartate aminotransferase and alanine aminotransferase results at 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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=23 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT n=23 Participants Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters	54 U/liter Standard Deviation 33	75 U/liter Standard Deviation 87

PRIMARY outcome

Timeframe: Week 48

Population: Participants with aspartate aminotransferase and alanine aminotransferase results at 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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=23 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT n=23 Participants Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters	60 U/liter Standard Deviation 41	79 U/liter Standard Deviation 92

PRIMARY outcome

Timeframe: Week 60

Population: Participants with aspartate aminotransferase and alanine aminotransferase results at 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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=23 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT n=23 Participants Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters	55 U/liter Standard Deviation 38	59 U/liter Standard Deviation 50

PRIMARY outcome

Timeframe: Week 72

Population: Participants with aspartate aminotransferase and alanine aminotransferase results at 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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=20 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT n=20 Participants Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters	51 U/liter Standard Deviation 36	50 U/liter Standard Deviation 35

PRIMARY outcome

Timeframe: Week 84

Population: Participants with aspartate aminotransferase and alanine aminotransferase results at 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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=17 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT n=18 Participants Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters	55 U/liter Standard Deviation 33	49 U/liter Standard Deviation 27

PRIMARY outcome

Timeframe: Week 96

Population: Participants with aspartate aminotransferase and alanine aminotransferase results at 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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=15 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT n=15 Participants Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters	63 U/liter Standard Deviation 44	63 U/liter Standard Deviation 45

PRIMARY outcome

Timeframe: Week 108

Population: Participants with aspartate aminotransferase and alanine aminotransferase results at 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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=18 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT n=19 Participants Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters	47 U/liter Standard Deviation 19	43 U/liter Standard Deviation 20

PRIMARY outcome

Timeframe: Week 120

Population: Participants with aspartate aminotransferase and alanine aminotransferase results at 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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=17 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT n=17 Participants Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters	56 U/liter Standard Deviation 30	65 U/liter Standard Deviation 39

PRIMARY outcome

Timeframe: Week 132

Population: Participants with aspartate aminotransferase and alanine aminotransferase results at 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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=15 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT n=15 Participants Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters	49 U/liter Standard Deviation 24	51 U/liter Standard Deviation 31

PRIMARY outcome

Timeframe: Week 144

Population: Participants with aspartate aminotransferase and alanine aminotransferase results at 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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=17 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT n=17 Participants Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters	52 U/liter Standard Deviation 28	53 U/liter Standard Deviation 36

PRIMARY outcome

Timeframe: Baseline

Population: Participants with HIV-1 RNA results at 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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=24 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Viral Load	3.9 log10 copies/mL Standard Deviation 1.4	—

PRIMARY outcome

Timeframe: Week 4

Population: Participants with HIV-1 RNA results at 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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=22 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Viral Load	2.5 log10 copies/mL Standard Deviation 0.8	—

PRIMARY outcome

Timeframe: Week 12

Population: Participants with HIV-1 RNA results at 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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=22 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Viral Load	2.0 log10 copies/mL Standard Deviation 0.5	—

PRIMARY outcome

Timeframe: Week 24

Population: Participants with HIV-1 RNA results at 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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=22 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Viral Load	1.7 log10 copies/mL Standard Deviation 0.4	—

PRIMARY outcome

Timeframe: Week 36

Population: Participants with HIV-1 RNA results at 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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=22 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Viral Load	1.6 log10 copies/mL Standard Deviation 0.2	—

PRIMARY outcome

Timeframe: Week 48

Population: Participants with HIV-1 RNA results at 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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=23 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Viral Load	1.7 log10 copies/mL Standard Deviation 0.3	—

PRIMARY outcome

Timeframe: Week 60

Population: Participants with HIV-1 RNA results at 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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=24 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Viral Load	1.7 log10 copies/mL Standard Deviation 0.4	—

PRIMARY outcome

Timeframe: Week 72

Population: Participants with HIV-1 RNA results at 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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=17 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Viral Load	1.6 log10 copies/mL Standard Deviation 0.2	—

PRIMARY outcome

Timeframe: Week 84

Population: Participants with HIV-1 RNA results at 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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=18 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Viral Load	1.5 log10 copies/mL Standard Deviation 0.3	—

PRIMARY outcome

Timeframe: Week 96

Population: Participants with HIV-1 RNA results at 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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=15 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Viral Load	1.6 log10 copies/mL Standard Deviation 0.3	—

PRIMARY outcome

Timeframe: Week 108

Population: Participants with HIV-1 RNA results at 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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=19 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Viral Load	1.6 log10 copies/mL Standard Deviation 0.4	—

PRIMARY outcome

Timeframe: Week 120

Population: Participants with HIV-1 RNA results at 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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=16 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Viral Load	1.6 log10 copies/mL Standard Deviation 0.4	—

PRIMARY outcome

Timeframe: Week 132

Population: Participants with HIV-1 RNA results at 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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=15 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Viral Load	1.6 log10 copies/mL Standard Deviation 0.3	—

PRIMARY outcome

Timeframe: Week 144

Population: Participants with HIV-1 RNA results at 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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=17 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
Viral Load	1.5 log10 copies/mL Standard Deviation 0.2	—

PRIMARY outcome

Timeframe: Baseline

Population: All participants with CD4+ cell count measurements at Baseline are included.

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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=33 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
CD4 Cell Count	288 CD4+ cells/μL Standard Deviation 192	—

PRIMARY outcome

Timeframe: Week 4

Population: All participants with CD4+ cell count measurements at Week 4 are included.

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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=22 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
CD4 Cell Count	350 CD4+ cells/μL Standard Deviation 165	—

PRIMARY outcome

Timeframe: Week 12

Population: All participants with CD4+ cell count measurements at Week 12 are included.

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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=23 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
CD4 Cell Count	378 CD4+ cells/μL Standard Deviation 204	—

PRIMARY outcome

Timeframe: Week 24

Population: All participants with CD4+ cell count measurements at Week 24 are included.

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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=23 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
CD4 Cell Count	383 CD4+ cells/μL Standard Deviation 211	—

PRIMARY outcome

Timeframe: Week 36

Population: All participants with CD4+ cell count measurements at Week 36 are included.

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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=22 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
CD4 Cell Count	408 CD4+ cells/μL Standard Deviation 187	—

PRIMARY outcome

Timeframe: Week 48

Population: All participants with CD4+ cell count measurements at Week 48 are included.

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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=23 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
CD4 Cell Count	402 CD4+ cells/μL Standard Deviation 239	—

PRIMARY outcome

Timeframe: Week 60

Population: All participants with CD4+ cell count measurements at Baseline are included.

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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=24 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
CD4 Cell Count	424 CD4+ cells/μL Standard Deviation 193	—

PRIMARY outcome

Timeframe: Week 72

Population: All participants with CD4+ cell count measurements at Week 72 are included.

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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=18 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
CD4 Cell Count	431 CD4+ cells/μL Standard Deviation 235	—

PRIMARY outcome

Timeframe: Week 84

Population: All participants with CD4+ cell count measurements at Week 84 are included.

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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=18 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
CD4 Cell Count	405 CD4+ cells/μL Standard Deviation 170	—

PRIMARY outcome

Timeframe: Week 96

Population: All participants with CD4+ cell count measurements at Week 96 are included.

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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=14 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
CD4 Cell Count	503 CD4+ cells/μL Standard Deviation 237	—

PRIMARY outcome

Timeframe: Week 108

Population: All participants with CD4+ cell count measurements at Week 108 are included.

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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=18 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
CD4 Cell Count	581 CD4+ cells/μL Standard Deviation 303	—

PRIMARY outcome

Timeframe: Week 120

Population: All participants with CD4+ cell count measurements at Week 120 are included.

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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=15 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
CD4 Cell Count	565 CD4+ cells/μL Standard Deviation 256	—

PRIMARY outcome

Timeframe: Week 132

Population: All participants with CD4+ cell count measurements at Week 132 are included.

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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=15 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
CD4 Cell Count	502 CD4+ cells/μL Standard Deviation 259	—

PRIMARY outcome

Timeframe: Week 144

Population: All participants with CD4+ cell count measurements at Week 144 are included.

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.

Outcome measures

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n=17 Participants Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.	HIV-infected Participants With Hepatitis Co-infection: ALT Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
CD4 Cell Count	525 CD4+ cells/μL Standard Deviation 226	—

Adverse Events

HIV-infected Participants With Hepatitis Co-infection

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	HIV-infected Participants With Hepatitis Co-infection n=33 participants at risk HIV-infected participants with co-infections of hepatitis B or hepatitis C.
Investigations antiviral drug level above therapeutic	3.0% 1/33 • Number of events 1 • Investigators were instructed to report adverse events throughout the study (up to 3 years).

Additional Information

Global Medical Services

Abbott

Phone: 1-800-633-9110

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER