Human Immunodeficiency Virus-Infection
Conditions
Keywords
Human Immunodeficiency Virus, Co-infection with Hepatitis B or Hepatitis C, Tolerability, Effectiveness
Brief summary
The aim of the study is to observe the tolerability and effectiveness of Kaletra in Human Immunodeficiency Virus/Hepatitis-B Virus and Human Immunodeficiency Virus/Hepatitis-C Virus co-infected patients.
Interventions
3 capsules 2xdaily or 2 tablets 2xdaily Kaletra
Sponsors
Abbott
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients infected by HIV-1 and HBV or HCV * Age ≥18 years * Patients who were initiated on a LPV/r containing antiretroviral (ARV) regimen
Exclusion criteria
\- Contraindications as described in SmPC (summary of product characteristics) at the time of prescription
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 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. |
| Viral Load | 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. |
| CD4 Cell Count | Baseline | The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Baseline are presented. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HIV-infected Participants With Hepatitis Co-infection HIV-infected participants with co-infections of hepatitis B or hepatitis C. | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Antiretroviral therapy break | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | HIV-infected Participants With Hepatitis Co-infection |
|---|---|
| Age Continuous | 42.4 years STANDARD_DEVIATION 7.1 |
| Duration of HIV infection | 9.7 years STANDARD_DEVIATION 7.4 |
| Hepatitis Co-infection Chronic hepatitis B | 9 participants |
| Hepatitis Co-infection Chronic hepatitis C | 24 participants |
| Region of Enrollment Germany | 33 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
Primary
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
Population: Participants with aspartate aminotransferase and alanine aminotransferase results at Week 72.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 51 U/liter | Standard Deviation 36 |
| HIV-infected Participants With Hepatitis Co-infection: ALT | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 50 U/liter | Standard Deviation 35 |
Primary
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
Population: Participants with aspartate aminotransferase and alanine aminotransferase results at Week 108.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 47 U/liter | Standard Deviation 19 |
| HIV-infected Participants With Hepatitis Co-infection: ALT | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 43 U/liter | Standard Deviation 20 |
Primary
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
Population: Participants with aspartate aminotransferase and alanine aminotransferase results at Week 120.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 56 U/liter | Standard Deviation 30 |
| HIV-infected Participants With Hepatitis Co-infection: ALT | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 65 U/liter | Standard Deviation 39 |
Primary
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
Population: Participants with aspartate aminotransferase and alanine aminotransferase results at Week 144.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 52 U/liter | Standard Deviation 28 |
| HIV-infected Participants With Hepatitis Co-infection: ALT | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 53 U/liter | Standard Deviation 36 |
Primary
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
Population: Participants with aspartate aminotransferase and alanine aminotransferase results at Week 96.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 63 U/liter | Standard Deviation 44 |
| HIV-infected Participants With Hepatitis Co-infection: ALT | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 63 U/liter | Standard Deviation 45 |
Primary
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
Population: Participants with aspartate aminotransferase and alanine aminotransferase results at Week 84.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 55 U/liter | Standard Deviation 33 |
| HIV-infected Participants With Hepatitis Co-infection: ALT | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 49 U/liter | Standard Deviation 27 |
Primary
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
Population: Participants with aspartate aminotransferase and alanine aminotransferase results at Week 132.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 49 U/liter | Standard Deviation 24 |
| HIV-infected Participants With Hepatitis Co-infection: ALT | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 51 U/liter | Standard Deviation 31 |
Primary
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
Population: Participants with aspartate aminotransferase and alanine aminotransferase results at Baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 64 U/liter | Standard Deviation 63 |
| HIV-infected Participants With Hepatitis Co-infection: ALT | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 69 U/liter | Standard Deviation 88 |
Primary
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
Population: Participants with aspartate aminotransferase and alanine aminotransferase results at Week 4.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 85 U/liter | Standard Deviation 96 |
| HIV-infected Participants With Hepatitis Co-infection: ALT | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 85 U/liter | Standard Deviation 86 |
Primary
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
Population: Participants with aspartate aminotransferase and alanine aminotransferase results at Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 69 U/liter | Standard Deviation 50 |
| HIV-infected Participants With Hepatitis Co-infection: ALT | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 85 U/liter | Standard Deviation 79 |
Primary
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
Population: Participants with aspartate aminotransferase and alanine aminotransferase results at Week 24.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 78 U/liter | Standard Deviation 94 |
| HIV-infected Participants With Hepatitis Co-infection: ALT | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 97 U/liter | Standard Deviation 134 |
Primary
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
Population: Participants with aspartate aminotransferase and alanine aminotransferase results at Week 36.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 54 U/liter | Standard Deviation 33 |
| HIV-infected Participants With Hepatitis Co-infection: ALT | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 75 U/liter | Standard Deviation 87 |
Primary
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
Population: Participants with aspartate aminotransferase and alanine aminotransferase results at Week 48.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 60 U/liter | Standard Deviation 41 |
| HIV-infected Participants With Hepatitis Co-infection: ALT | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 79 U/liter | Standard Deviation 92 |
Primary
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
Population: Participants with aspartate aminotransferase and alanine aminotransferase results at Week 60.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 55 U/liter | Standard Deviation 38 |
| HIV-infected Participants With Hepatitis Co-infection: ALT | Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters | 59 U/liter | Standard Deviation 50 |
Primary
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
Population: All participants with CD4+ cell count measurements at Baseline are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | CD4 Cell Count | 288 CD4+ cells/μL | Standard Deviation 192 |
Primary
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
Population: All participants with CD4+ cell count measurements at Week 4 are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | CD4 Cell Count | 350 CD4+ cells/μL | Standard Deviation 165 |
Primary
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
Population: All participants with CD4+ cell count measurements at Week 12 are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | CD4 Cell Count | 378 CD4+ cells/μL | Standard Deviation 204 |
Primary
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
Population: All participants with CD4+ cell count measurements at Week 24 are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | CD4 Cell Count | 383 CD4+ cells/μL | Standard Deviation 211 |
Primary
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
Population: All participants with CD4+ cell count measurements at Week 36 are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | CD4 Cell Count | 408 CD4+ cells/μL | Standard Deviation 187 |
Primary
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
Population: All participants with CD4+ cell count measurements at Week 48 are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | CD4 Cell Count | 402 CD4+ cells/μL | Standard Deviation 239 |
Primary
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
Population: All participants with CD4+ cell count measurements at Baseline are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | CD4 Cell Count | 424 CD4+ cells/μL | Standard Deviation 193 |
Primary
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
Population: All participants with CD4+ cell count measurements at Week 72 are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | CD4 Cell Count | 431 CD4+ cells/μL | Standard Deviation 235 |
Primary
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
Population: All participants with CD4+ cell count measurements at Week 84 are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | CD4 Cell Count | 405 CD4+ cells/μL | Standard Deviation 170 |
Primary
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
Population: All participants with CD4+ cell count measurements at Week 96 are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | CD4 Cell Count | 503 CD4+ cells/μL | Standard Deviation 237 |
Primary
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
Population: All participants with CD4+ cell count measurements at Week 108 are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | CD4 Cell Count | 581 CD4+ cells/μL | Standard Deviation 303 |
Primary
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
Population: All participants with CD4+ cell count measurements at Week 120 are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | CD4 Cell Count | 565 CD4+ cells/μL | Standard Deviation 256 |
Primary
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
Population: All participants with CD4+ cell count measurements at Week 132 are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | CD4 Cell Count | 502 CD4+ cells/μL | Standard Deviation 259 |
Primary
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
Population: All participants with CD4+ cell count measurements at Week 144 are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | CD4 Cell Count | 525 CD4+ cells/μL | Standard Deviation 226 |
Primary
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
Population: Participants with HIV-1 RNA results at Week 108.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | Viral Load | 1.6 log10 copies/mL | Standard Deviation 0.4 |
Primary
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
Population: Participants with HIV-1 RNA results at Week 120.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | Viral Load | 1.6 log10 copies/mL | Standard Deviation 0.4 |
Primary
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
Population: Participants with HIV-1 RNA results at Week 144.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | Viral Load | 1.5 log10 copies/mL | Standard Deviation 0.2 |
Primary
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
Population: Participants with HIV-1 RNA results at Week 132.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | Viral Load | 1.6 log10 copies/mL | Standard Deviation 0.3 |
Primary
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
Population: Participants with HIV-1 RNA results at Baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | Viral Load | 3.9 log10 copies/mL | Standard Deviation 1.4 |
Primary
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
Population: Participants with HIV-1 RNA results at Week 4.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | Viral Load | 2.5 log10 copies/mL | Standard Deviation 0.8 |
Primary
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
Population: Participants with HIV-1 RNA results at Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | Viral Load | 2.0 log10 copies/mL | Standard Deviation 0.5 |
Primary
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
Population: Participants with HIV-1 RNA results at Week 24.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | Viral Load | 1.7 log10 copies/mL | Standard Deviation 0.4 |
Primary
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
Population: Participants with HIV-1 RNA results at Week 36.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | Viral Load | 1.6 log10 copies/mL | Standard Deviation 0.2 |
Primary
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
Population: Participants with HIV-1 RNA results at Week 48.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | Viral Load | 1.7 log10 copies/mL | Standard Deviation 0.3 |
Primary
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
Population: Participants with HIV-1 RNA results at Week 60.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | Viral Load | 1.7 log10 copies/mL | Standard Deviation 0.4 |
Primary
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
Population: Participants with HIV-1 RNA results at Week 72.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | Viral Load | 1.6 log10 copies/mL | Standard Deviation 0.2 |
Primary
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
Population: Participants with HIV-1 RNA results at Week 84.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | Viral Load | 1.5 log10 copies/mL | Standard Deviation 0.3 |
Primary
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
Population: Participants with HIV-1 RNA results at Week 96.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV-infected Participants With Hepatitis Co-infection: AST | Viral Load | 1.6 log10 copies/mL | Standard Deviation 0.3 |