Human Immunodeficiency Virus
Conditions
Keywords
Viral load, Resistance, Double protease inhibitors, Mutations, Immune system, Infection, Nucleoside Reverse Transcriptase Inhibitors-free, Human Immunodeficiency Virus
Brief summary
Therapy with lopinavir/ritonavir (Kaletra) and one other protease inhibitor in Human Immunodeficiency Virus participants
Detailed description
This study is intended to observe and collect data on the usage, dosing, tolerability, and effectiveness of lopinavir/ritonavir (Kaletra) when used as part of a Nucleoside Reverse Transcriptase Inhibitors-free double protease regimen. Enrollment in the study was independent of the decision to prescribe Kaletra.
Interventions
None listed
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with Human Immunodeficiency Virus infection * Participants on lopinavir/ritonavir (Kaletra) and one other protease inhibitor
Exclusion criteria
* Hypersensitivity against lopinavir, ritonavir or other ingredients * Severe liver insufficiency * No concomitant astemizole, terfenadine, oral midazolam, triazolam, cisapride, pimozide, amiodarone, ergotamine, dihydroergotamine, ergometrine, methylergometrine, vardenafil and St. John's wort
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL | Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 | Viral load (number of HIV-1 RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments. The percentage of participants with HIV RNA less than 50 copies/mL at each time point is presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Absolute CD4 Cell Count | Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 | Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits. |
| Change From Baseline in Relative CD4 Cell Count | Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 | Increases in relative CD4 count (the percentage of total lymphocytes that are CD4 cells) are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the percentage of CD4+ cells at scheduled study visits. |
| Change From Baseline in Absolute CD8 Cell Count | Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 | Decreases in CD8 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD8-positive (CD8+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD8+ cells at scheduled study visits. |
| Change From Baseline in Relative CD8 Cell Count | Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 | Decreases in relative CD8 count (the percentage of total lymphocytes that are CD8 cells) are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD8-positive (CD8+) T-lymphocyte counts were assessed by measuring the change from Baseline in the percentage of CD8+ cells at scheduled study visits. |
| Change From Baseline in CD4/CD8 T-cell Ratio | Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 | The CD4/CD8 T-cell ratio, also known as the T-lymphocyte helper/suppressor profile, presents the number of lymphocytes in the blood positive for CD4 cells compared with the number positive for CD8 cells. Changes in participants' CD4/CD8 T-lymphocyte ratio were assessed by measuring the change from Baseline in the ratio at scheduled study visits. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HIV-infected Participants HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.
Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily). | 60 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Co-morbidities | 1 |
| Overall Study | Death | 1 |
| Overall Study | Intensification | 3 |
| Overall Study | Noncompliance | 3 |
| Overall Study | Patient's Wish | 2 |
| Overall Study | Therapy Break | 3 |
| Overall Study | Unknown Reasons | 1 |
Baseline characteristics
| Characteristic | HIV-infected Participants |
|---|---|
| Age Continuous | 44.2 years STANDARD_DEVIATION 9 |
| Region of Enrollment Germany | 60 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 65 |
| serious Total, serious adverse events | 4 / 65 |
Outcome results
Primary
Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL
Viral load (number of HIV-1 RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments. The percentage of participants with HIV RNA less than 50 copies/mL at each time point is presented.
Time frame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
Population: Evaluable participants. n=number of evaluable participants with given measurement at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HIV-infected Participants | Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL | Baseline (n=58) | 8.6 percentage of participants |
| HIV-infected Participants | Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL | Week 4 (n=42) | 26.2 percentage of participants |
| HIV-infected Participants | Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL | Week 12 (n=50) | 40.0 percentage of participants |
| HIV-infected Participants | Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL | Week 24 (n=48) | 56.3 percentage of participants |
| HIV-infected Participants | Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL | Week 36 (n=42) | 69.1 percentage of participants |
| HIV-infected Participants | Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL | Week 48 (n=41) | 65.9 percentage of participants |
| HIV-infected Participants | Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL | Week 60 (n=38) | 68.4 percentage of participants |
| HIV-infected Participants | Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL | Week 72 (n=38) | 76.3 percentage of participants |
| HIV-infected Participants | Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL | Week 84 (n=34) | 76.5 percentage of participants |
| HIV-infected Participants | Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL | Week 96 (n=30) | 56.7 percentage of participants |
| HIV-infected Participants | Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL | Week 108 (n=34) | 58.8 percentage of participants |
| HIV-infected Participants | Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL | Week 120 (n=30) | 63.3 percentage of participants |
| HIV-infected Participants | Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL | Week 132 (n=31) | 58.1 percentage of participants |
| HIV-infected Participants | Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL | Week 144 (n=29) | 69.0 percentage of participants |
Secondary
Change From Baseline in Absolute CD4 Cell Count
Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
Time frame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
Population: Evaluable participants. n=number of evaluable participants with given measurement at time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-infected Participants | Change From Baseline in Absolute CD4 Cell Count | Baseline (n=58) | 312.0 cells/µL | Standard Deviation 227 |
| HIV-infected Participants | Change From Baseline in Absolute CD4 Cell Count | Change at Week 4 (n=44) | 48.2 cells/µL | Standard Deviation 134 |
| HIV-infected Participants | Change From Baseline in Absolute CD4 Cell Count | Change at Week 12 (n=51) | 115.7 cells/µL | Standard Deviation 186 |
| HIV-infected Participants | Change From Baseline in Absolute CD4 Cell Count | Change at Week 24 (n=48) | 124.5 cells/µL | Standard Deviation 176 |
| HIV-infected Participants | Change From Baseline in Absolute CD4 Cell Count | Change at Week 36 (n=43) | 122.6 cells/µL | Standard Deviation 216 |
| HIV-infected Participants | Change From Baseline in Absolute CD4 Cell Count | Change at Week 48 (n=42) | 129.0 cells/µL | Standard Deviation 247 |
| HIV-infected Participants | Change From Baseline in Absolute CD4 Cell Count | Change at Week 60 (n=38) | 155.4 cells/µL | Standard Deviation 267 |
| HIV-infected Participants | Change From Baseline in Absolute CD4 Cell Count | Change at Week 72 (n=38) | 180.8 cells/µL | Standard Deviation 200 |
| HIV-infected Participants | Change From Baseline in Absolute CD4 Cell Count | Change at Week 84 (n=33) | 225.7 cells/µL | Standard Deviation 217 |
| HIV-infected Participants | Change From Baseline in Absolute CD4 Cell Count | Change at Week 96 (n=30) | 227.7 cells/µL | Standard Deviation 210 |
| HIV-infected Participants | Change From Baseline in Absolute CD4 Cell Count | Change at Week 108 (n=35) | 274.7 cells/µL | Standard Deviation 244 |
| HIV-infected Participants | Change From Baseline in Absolute CD4 Cell Count | Change at Week 120 (n=30) | 274.3 cells/µL | Standard Deviation 284 |
| HIV-infected Participants | Change From Baseline in Absolute CD4 Cell Count | Change at Week 132 (n=31) | 260.8 cells/µL | Standard Deviation 214 |
| HIV-infected Participants | Change From Baseline in Absolute CD4 Cell Count | Change at Week 144 (n=28) | 271.8 cells/µL | Standard Deviation 232 |
Secondary
Change From Baseline in Absolute CD8 Cell Count
Decreases in CD8 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD8-positive (CD8+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD8+ cells at scheduled study visits.
Time frame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
Population: Evaluable participants. n=number of evaluable participants with given measurement at time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-infected Participants | Change From Baseline in Absolute CD8 Cell Count | Change at Week 36 (n=43) | -59 cells/µL | Standard Deviation 774 |
| HIV-infected Participants | Change From Baseline in Absolute CD8 Cell Count | Baseline (n=60) | 1180.8 cells/µL | Standard Deviation 713 |
| HIV-infected Participants | Change From Baseline in Absolute CD8 Cell Count | Change at Week 4 (n=44) | 109 cells/µL | Standard Deviation 728 |
| HIV-infected Participants | Change From Baseline in Absolute CD8 Cell Count | Change at Week 12 (n=51) | 195 cells/µL | Standard Deviation 762 |
| HIV-infected Participants | Change From Baseline in Absolute CD8 Cell Count | Change at Week 24 (n=49) | 66 cells/µL | Standard Deviation 671 |
| HIV-infected Participants | Change From Baseline in Absolute CD8 Cell Count | Change at Week 48 (n=42) | -105 cells/µL | Standard Deviation 777 |
| HIV-infected Participants | Change From Baseline in Absolute CD8 Cell Count | Change at Week 60 (n=38) | -42 cells/µL | Standard Deviation 706 |
| HIV-infected Participants | Change From Baseline in Absolute CD8 Cell Count | Change at Week 72 (n=38) | 4 cells/µL | Standard Deviation 676 |
| HIV-infected Participants | Change From Baseline in Absolute CD8 Cell Count | Change at Week 84 (n=33) | 132 cells/µL | Standard Deviation 637 |
| HIV-infected Participants | Change From Baseline in Absolute CD8 Cell Count | Change at Week 96 (n=30) | 54 cells/µL | Standard Deviation 616 |
| HIV-infected Participants | Change From Baseline in Absolute CD8 Cell Count | Change at Week 108 (n=35) | 39 cells/µL | Standard Deviation 529 |
| HIV-infected Participants | Change From Baseline in Absolute CD8 Cell Count | Change at Week 120 (n=30) | 24 cells/µL | Standard Deviation 721 |
| HIV-infected Participants | Change From Baseline in Absolute CD8 Cell Count | Change at Week 132 (n=31) | -57 cells/µL | Standard Deviation 676 |
| HIV-infected Participants | Change From Baseline in Absolute CD8 Cell Count | Change at Week 144 (n=28) | -3 cells/µL | Standard Deviation 644 |
Secondary
Change From Baseline in CD4/CD8 T-cell Ratio
The CD4/CD8 T-cell ratio, also known as the T-lymphocyte helper/suppressor profile, presents the number of lymphocytes in the blood positive for CD4 cells compared with the number positive for CD8 cells. Changes in participants' CD4/CD8 T-lymphocyte ratio were assessed by measuring the change from Baseline in the ratio at scheduled study visits.
Time frame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
Population: Evaluable participants. n=number of evaluable participants with given measurement at time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-infected Participants | Change From Baseline in CD4/CD8 T-cell Ratio | Change at Week 132 (n=31) | 0.3 ratio | Standard Deviation 0.3 |
| HIV-infected Participants | Change From Baseline in CD4/CD8 T-cell Ratio | Change at Week 144 (n=28) | 0.3 ratio | Standard Deviation 0.4 |
| HIV-infected Participants | Change From Baseline in CD4/CD8 T-cell Ratio | Baseline (n=60) | 0.3 ratio | Standard Deviation 0.2 |
| HIV-infected Participants | Change From Baseline in CD4/CD8 T-cell Ratio | Change at Week 4 (n=44) | 0.1 ratio | Standard Deviation 0.1 |
| HIV-infected Participants | Change From Baseline in CD4/CD8 T-cell Ratio | Change at Week 12 (n=51) | 0.1 ratio | Standard Deviation 0.2 |
| HIV-infected Participants | Change From Baseline in CD4/CD8 T-cell Ratio | Change at Week 24 (n=48) | 0.1 ratio | Standard Deviation 0.2 |
| HIV-infected Participants | Change From Baseline in CD4/CD8 T-cell Ratio | Change at Week 36 (n=43) | 0.2 ratio | Standard Deviation 0.3 |
| HIV-infected Participants | Change From Baseline in CD4/CD8 T-cell Ratio | Change at Week 48 (n=42) | 0.2 ratio | Standard Deviation 0.3 |
| HIV-infected Participants | Change From Baseline in CD4/CD8 T-cell Ratio | Change at Week 60 (n=38) | 0.3 ratio | Standard Deviation 0.3 |
| HIV-infected Participants | Change From Baseline in CD4/CD8 T-cell Ratio | Change at Week 72 (n=38) | 0.2 ratio | Standard Deviation 0.3 |
| HIV-infected Participants | Change From Baseline in CD4/CD8 T-cell Ratio | Change at Week 84 (n=33) | 0.3 ratio | Standard Deviation 0.3 |
| HIV-infected Participants | Change From Baseline in CD4/CD8 T-cell Ratio | Change at Week 96 (n=30) | 0.2 ratio | Standard Deviation 0.2 |
| HIV-infected Participants | Change From Baseline in CD4/CD8 T-cell Ratio | Change at Week 108 (n=35) | 0.3 ratio | Standard Deviation 0.3 |
| HIV-infected Participants | Change From Baseline in CD4/CD8 T-cell Ratio | Change at Week 120 (n=30) | 0.3 ratio | Standard Deviation 0.3 |
Secondary
Change From Baseline in Relative CD4 Cell Count
Increases in relative CD4 count (the percentage of total lymphocytes that are CD4 cells) are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the percentage of CD4+ cells at scheduled study visits.
Time frame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
Population: Evaluable participants. n=number of evaluable participants with given measurement at time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-infected Participants | Change From Baseline in Relative CD4 Cell Count | Baseline (n=59) | 16.8 percentage of cells | Standard Deviation 9.4 |
| HIV-infected Participants | Change From Baseline in Relative CD4 Cell Count | Change at Week 4 (n=42) | 1.4 percentage of cells | Standard Deviation 3.3 |
| HIV-infected Participants | Change From Baseline in Relative CD4 Cell Count | Change at Week 12 (n=45) | 2.8 percentage of cells | Standard Deviation 5.2 |
| HIV-infected Participants | Change From Baseline in Relative CD4 Cell Count | Change at Week 24 (n=42) | 4.1 percentage of cells | Standard Deviation 5.6 |
| HIV-infected Participants | Change From Baseline in Relative CD4 Cell Count | Change at Week 36 (n=38) | 4.9 percentage of cells | Standard Deviation 7 |
| HIV-infected Participants | Change From Baseline in Relative CD4 Cell Count | Change at Week 48 (n=35) | 4.9 percentage of cells | Standard Deviation 6.7 |
| HIV-infected Participants | Change From Baseline in Relative CD4 Cell Count | Change at Week 60 (n=32) | 5.4 percentage of cells | Standard Deviation 6.2 |
| HIV-infected Participants | Change From Baseline in Relative CD4 Cell Count | Change at Week 72 (n=32) | 5.0 percentage of cells | Standard Deviation 6.4 |
| HIV-infected Participants | Change From Baseline in Relative CD4 Cell Count | Change at Week 84 (n=28) | 5.7 percentage of cells | Standard Deviation 6.4 |
| HIV-infected Participants | Change From Baseline in Relative CD4 Cell Count | Change at Week 96 (n=24) | 6.3 percentage of cells | Standard Deviation 5.3 |
| HIV-infected Participants | Change From Baseline in Relative CD4 Cell Count | Change at Week 108 (n=28) | 7.9 percentage of cells | Standard Deviation 7.4 |
| HIV-infected Participants | Change From Baseline in Relative CD4 Cell Count | Change at Week 120 (n=24) | 7.6 percentage of cells | Standard Deviation 9 |
| HIV-infected Participants | Change From Baseline in Relative CD4 Cell Count | Change at Week 132 (n=25) | 8.4 percentage of cells | Standard Deviation 8.9 |
| HIV-infected Participants | Change From Baseline in Relative CD4 Cell Count | Change at Week 144 (n=23) | 8.6 percentage of cells | Standard Deviation 8 |
Secondary
Change From Baseline in Relative CD8 Cell Count
Decreases in relative CD8 count (the percentage of total lymphocytes that are CD8 cells) are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD8-positive (CD8+) T-lymphocyte counts were assessed by measuring the change from Baseline in the percentage of CD8+ cells at scheduled study visits.
Time frame: Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
Population: Evaluable participants. n=number of evaluable participants with given measurement at time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-infected Participants | Change From Baseline in Relative CD8 Cell Count | Baseline (n=59) | 60.4 percentage of cells | Standard Deviation 15 |
| HIV-infected Participants | Change From Baseline in Relative CD8 Cell Count | Change at Week 4 (n=41) | -2.2 percentage of cells | Standard Deviation 13.9 |
| HIV-infected Participants | Change From Baseline in Relative CD8 Cell Count | Change at Week 12 (n=45) | -2.1 percentage of cells | Standard Deviation 15.8 |
| HIV-infected Participants | Change From Baseline in Relative CD8 Cell Count | Change at Week 24 (n=42) | -7.1 percentage of cells | Standard Deviation 11.6 |
| HIV-infected Participants | Change From Baseline in Relative CD8 Cell Count | Change at Week 36 (n=38) | -8.2 percentage of cells | Standard Deviation 12.1 |
| HIV-infected Participants | Change From Baseline in Relative CD8 Cell Count | Change at Week 48 (n=35) | -8.6 percentage of cells | Standard Deviation 12.1 |
| HIV-infected Participants | Change From Baseline in Relative CD8 Cell Count | Change at Week 60 (n=32) | -11.0 percentage of cells | Standard Deviation 9.4 |
| HIV-infected Participants | Change From Baseline in Relative CD8 Cell Count | Change at Week 72 (n=31) | -10.9 percentage of cells | Standard Deviation 12.4 |
| HIV-infected Participants | Change From Baseline in Relative CD8 Cell Count | Change at Week 84 (n=28) | -10.7 percentage of cells | Standard Deviation 13.3 |
| HIV-infected Participants | Change From Baseline in Relative CD8 Cell Count | Change at Week 96 (n=24) | -10.0 percentage of cells | Standard Deviation 12.7 |
| HIV-infected Participants | Change From Baseline in Relative CD8 Cell Count | Change at Week 108 (n=28) | -13.2 percentage of cells | Standard Deviation 13 |
| HIV-infected Participants | Change From Baseline in Relative CD8 Cell Count | Change at Week 120 (n=24) | -11.5 percentage of cells | Standard Deviation 13.4 |
| HIV-infected Participants | Change From Baseline in Relative CD8 Cell Count | Change at Week 132 (n=25) | -13.1 percentage of cells | Standard Deviation 12.8 |
| HIV-infected Participants | Change From Baseline in Relative CD8 Cell Count | Change at Week 144 (n=23) | -13.5 percentage of cells | Standard Deviation 13.4 |