Trial Outcomes & Findings for The Effectiveness of Dual Therapy (Lopinavir/Ritonavir + LamivudinE) in Treatment-Experienced HIV Infected Patients in the Russian Federation (NCT NCT02581202)
NCT ID: NCT02581202
Last Updated: 2019-06-06
Results Overview
Recruitment status
COMPLETED
Target enrollment
216 participants
Primary outcome timeframe
Week 48
Results posted on
2019-06-06
Participant Flow
Participant milestones
| Measure |
Human Immunodeficiency Virus 1 (HIV-1) Infected Participants
HIV-1-infected participants on any triple highly active antiretroviral therapy (HAART) with plasma HIV-1 ribonucleic acid (RNA) level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to lopinavir with ritonavir plus lamivudine (LPV/r+3TC) as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
|
|---|---|
|
Overall Study
STARTED
|
216
|
|
Overall Study
COMPLETED
|
202
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Human Immunodeficiency Virus 1 (HIV-1) Infected Participants
HIV-1-infected participants on any triple highly active antiretroviral therapy (HAART) with plasma HIV-1 ribonucleic acid (RNA) level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to lopinavir with ritonavir plus lamivudine (LPV/r+3TC) as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
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|---|---|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Pregnancy
|
3
|
Baseline Characteristics
participants with an evaluable baseline assessment
Baseline characteristics by cohort
| Measure |
HIV-1 Infected Participants
n=216 Participants
HIV-1infected participants on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
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|---|---|
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Age, Continuous
|
38.1 years
STANDARD_DEVIATION 8.5 • n=216 Participants
|
|
Sex: Female, Male
Female
|
144 Participants
n=216 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=216 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
216 Participants
n=216 Participants
|
|
Absolute HIV-1 RNA Viral Load (Untransformed Data)
|
25.00 copies/mL
STANDARD_DEVIATION 0.000 • n=216 Participants
|
|
HIV-1 RNA Viral Load (Log10-Transformed Data)
|
3.22 log10 copies/mL
STANDARD_DEVIATION 0.000 • n=216 Participants
|
|
CD4+T-Cell Counts (%)
|
31.44 percentage of lymphocytes that are CD4+
STANDARD_DEVIATION 8.396 • n=216 Participants
|
|
CD4+T-Cell Counts (cells/mm^3)
|
641.37 cells/mm^3
STANDARD_DEVIATION 251.417 • n=216 Participants
|
|
Arm Circumference
|
30.03 cm
STANDARD_DEVIATION 5.290 • n=216 Participants
|
|
Hip Circumference
|
53.92 cm
STANDARD_DEVIATION 7.096 • n=216 Participants
|
|
Waist Circumference
|
82.79 cm
STANDARD_DEVIATION 11.579 • n=216 Participants
|
|
Alanine Aminotransferase (U/L)
|
31.48 U/L
STANDARD_DEVIATION 33.910 • n=200 Participants • participants with an evaluable baseline assessment
|
|
Alanine Aminotransferase (µmol/L)
|
20.75 µmol/L
STANDARD_DEVIATION 7.979 • n=16 Participants • participants with an evaluable baseline assessment
|
|
Aspartate Aminotransferase (U/L)
|
27.69 U/L
STANDARD_DEVIATION 22.913 • n=200 Participants • participants with an evaluable baseline assessment
|
|
Aspartate Aminotransferase (µmol/L)
|
21.56 µmol/L
STANDARD_DEVIATION 11.933 • n=16 Participants • participants with an evaluable baseline assessment
|
|
Glucose
|
4.96 mmol/L
STANDARD_DEVIATION 0.590 • n=216 Participants
|
|
High Density Lipoprotein (HDL)
|
1.45 mmol/L
STANDARD_DEVIATION 0.479 • n=117 Participants • participants with an evaluable baseline assessment
|
|
Insulin
|
9.32 µEq/mL
STANDARD_DEVIATION 2.085 • n=35 Participants • participants with an evaluable baseline assessment
|
|
Low Density Lipoprotein (LDL)
|
2.75 mmol/L
STANDARD_DEVIATION 0.866 • n=106 Participants • participants with an evaluable baseline assessment
|
|
Serum Creatinine
|
78.61 µmol/L
STANDARD_DEVIATION 18.136 • n=208 Participants • participants with an evaluable baseline assessment
|
|
Total Cholesterol
|
5.04 mmol/L
STANDARD_DEVIATION 0.980 • n=214 Participants • participants with an evaluable baseline assessment
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Triglycerides
|
2.29 mmol/L
STANDARD_DEVIATION 8.107 • n=189 Participants • participants with an evaluable assessment at baseline
|
PRIMARY outcome
Timeframe: Week 48Population: Participants with an assessment at given time point.
Outcome measures
| Measure |
HIV-1 Infected Participants
n=201 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
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|---|---|
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Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 48
|
100 percentage of participants
Interval 98.18 to 100.0
|
SECONDARY outcome
Timeframe: Week 24Population: Participants with an assessment at given time point.
Outcome measures
| Measure |
HIV-1 Infected Participants
n=203 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
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|---|---|
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Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 24
|
99.5 percentage of participants
Interval 97.29 to 99.99
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Participants with data on HIV-1 RNA viral load at given time point.
Outcome measures
| Measure |
HIV-1 Infected Participants
n=203 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
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|---|---|
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Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Untransformed Data)
Absolute values
|
25.22 copies/mL
Standard Deviation 3.158
|
|
Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Untransformed Data)
Change from BL
|
0.22 copies/mL
Standard Deviation 3.158
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Participants with data on HIV-1 RNA viral load at given time point.
Outcome measures
| Measure |
HIV-1 Infected Participants
n=203 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
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|---|---|
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Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Base-10 Logarithm Transformed Data)
Absolute values
|
3.22 log10 copies/mL
Standard Deviation 0.072
|
|
Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Base-10 Logarithm Transformed Data)
Change from BL
|
0.01 log10 copies/mL
Standard Deviation 0.072
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants with data on HIV-1 RNA viral load at given time point.
Statistics for absolute HIV-1 RNA viral load, where all participants with undetectable HIV-1-RNA viral load data were included into calculations with half of the lower indication limit (50/2 copies/mL, or 25.00 copies/mL).
Outcome measures
| Measure |
HIV-1 Infected Participants
n=201 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
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|---|---|
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Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Untransformed Data)
Absolute values
|
25.00 copies/mL
Standard Deviation 0.000
|
|
Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Untransformed Data)
Change from BL
|
0.00 copies/mL
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants with data on HIV-1 RNA viral load at given time point.
Outcome measures
| Measure |
HIV-1 Infected Participants
n=201 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
|
|---|---|
|
Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Base-10 Logarithm Transformed Data)
Absolute values
|
3.22 log10 copies/mL
Standard Deviation 0.000
|
|
Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Base-10 Logarithm Transformed Data)
Change from BL
|
0.000 log10 copies/mL
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Participants with valid measurements at given time point.
Outcome measures
| Measure |
HIV-1 Infected Participants
n=205 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
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|---|---|
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Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 24
Absolute values
|
32.50 percentage of lymphocytes that are CD4+
Standard Deviation 7.554
|
|
Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 24
Change from BL
|
0.96 percentage of lymphocytes that are CD4+
Standard Deviation 4.879
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants with valid measurements at given time point.
Outcome measures
| Measure |
HIV-1 Infected Participants
n=202 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
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|---|---|
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Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 48
Absolute values
|
33.11 percentage of lymphocytes that are CD4+
Standard Deviation 7.860
|
|
Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 48
Change from BL
|
1.43 percentage of lymphocytes that are CD4+
Standard Deviation 6.314
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Participants with valid measurements at given time point.
Outcome measures
| Measure |
HIV-1 Infected Participants
n=205 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
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|---|---|
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Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 24
Absolute values
|
703.43 cells/mm^3
Standard Deviation 223.790
|
|
Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 24
Change from BL
|
64.70 cells/mm^3
Standard Deviation 165.060
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants with valid measurements at given time point.
Outcome measures
| Measure |
HIV-1 Infected Participants
n=202 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
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|---|---|
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Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 48
Absolute values
|
752.44 cells/mm^3
Standard Deviation 234.366
|
|
Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 48
Change from BL
|
111.75 cells/mm^3
Standard Deviation 184.477
|
SECONDARY outcome
Timeframe: Week 48Population: Participants with HIV-1 RNA viral load detected levels of ≥ 50 copies/mL up to Week 24.
Outcome measures
| Measure |
HIV-1 Infected Participants
n=5 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
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|---|---|
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Number of Participants Who Developed Resistance to Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs), and Protease Inhibitors (PIs)
NRTI
|
1 Participants
|
|
Number of Participants Who Developed Resistance to Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs), and Protease Inhibitors (PIs)
NNRTI
|
1 Participants
|
|
Number of Participants Who Developed Resistance to Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs), and Protease Inhibitors (PIs)
PI
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Participants with measurements at given time point.
Outcome measures
| Measure |
HIV-1 Infected Participants
n=205 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
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|---|---|
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Absolute Values and Change From Baseline in Anthropometric Measurements At Week 24
Absolute values: arm circumference
|
29.82 cm
Standard Deviation 4.617
|
|
Absolute Values and Change From Baseline in Anthropometric Measurements At Week 24
Change from BL: arm circumference
|
-0.38 cm
Standard Deviation 2.953
|
|
Absolute Values and Change From Baseline in Anthropometric Measurements At Week 24
Absolute values: hip circumference
|
54.62 cm
Standard Deviation 8.112
|
|
Absolute Values and Change From Baseline in Anthropometric Measurements At Week 24
Change from BL: hip circumference
|
0.57 cm
Standard Deviation 5.575
|
|
Absolute Values and Change From Baseline in Anthropometric Measurements At Week 24
Absolute values: waist circumference
|
83.29 cm
Standard Deviation 12.282
|
|
Absolute Values and Change From Baseline in Anthropometric Measurements At Week 24
Change from BL: waist circumference
|
0.31 cm
Standard Deviation 5.998
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants with measurements at given time point.
Outcome measures
| Measure |
HIV-1 Infected Participants
n=202 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
|
|---|---|
|
Absolute Values and Change From Baseline in Anthropometric Measurements At Week 48
Absolute values: arm circumference
|
30.05 cm
Standard Deviation 4.781
|
|
Absolute Values and Change From Baseline in Anthropometric Measurements At Week 48
Change from BL: arm circumference
|
-0.20 cm
Standard Deviation 2.935
|
|
Absolute Values and Change From Baseline in Anthropometric Measurements At Week 48
Absolute values: hip circumference
|
55.25 cm
Standard Deviation 8.395
|
|
Absolute Values and Change From Baseline in Anthropometric Measurements At Week 48
Change from BL: hip circumference
|
1.14 cm
Standard Deviation 6.739
|
|
Absolute Values and Change From Baseline in Anthropometric Measurements At Week 48
Absolute values: waist circumference
|
83.64 cm
Standard Deviation 12.742
|
|
Absolute Values and Change From Baseline in Anthropometric Measurements At Week 48
Change from BL: waist circumference
|
0.63 cm
Standard Deviation 6.026
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Participants with measurements at given time point.
Outcome measures
| Measure |
HIV-1 Infected Participants
n=188 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
|
|---|---|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (U/L)
Absolute values
|
29.37 U/L
Standard Deviation 28.674
|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (U/L)
Change from BL
|
-1.31 U/L
Standard Deviation 21.483
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants with measurements at given time point.
Outcome measures
| Measure |
HIV-1 Infected Participants
n=186 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
|
|---|---|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (U/L)
Absolute values
|
28.35 U/L
Standard Deviation 28.386
|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (U/L)
Change from BL
|
-2.14 U/L
Standard Deviation 25.666
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Participants with measurements at given time point.
Outcome measures
| Measure |
HIV-1 Infected Participants
n=16 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
|
|---|---|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (µmol/L)
Absolute values
|
39.81 µmol/L
Standard Deviation 36.996
|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (µmol/L)
Change from BL
|
19.06 µmol/L
Standard Deviation 35.093
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants with measurements at given time point.
Outcome measures
| Measure |
HIV-1 Infected Participants
n=16 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
|
|---|---|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (µmol/L)
Absolute values
|
27.56 µmol/L
Standard Deviation 11.950
|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (µmol/L)
Change from BL
|
6.81 µmol/L
Standard Deviation 10.950
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Participants with measurements at given time point.
Outcome measures
| Measure |
HIV-1 Infected Participants
n=187 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
|
|---|---|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (U/L)
Absolute values
|
26.90 U/L
Standard Deviation 21.575
|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (U/L)
Change from BL
|
-0.38 U/L
Standard Deviation 17.234
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants with measurements at given time point.
Outcome measures
| Measure |
HIV-1 Infected Participants
n=185 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
|
|---|---|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (U/L)
Absolute values
|
26.92 U/L
Standard Deviation 21.050
|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (U/L)
Change from BL
|
-0.49 U/L
Standard Deviation 20.640
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Participants with measurements at given time point.
Outcome measures
| Measure |
HIV-1 Infected Participants
n=16 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
|
|---|---|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (µmol/L)
Absolute values
|
46.56 µmol/L
Standard Deviation 65.596
|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (µmol/L)
Change from BL
|
25.00 µmol/L
Standard Deviation 65.300
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants with measurements at given time point.
Outcome measures
| Measure |
HIV-1 Infected Participants
n=16 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
|
|---|---|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (µmol/L)
Absolute values
|
27.19 µmol/L
Standard Deviation 14.543
|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (µmol/L)
Change from BL
|
5.63 µmol/L
Standard Deviation 10.966
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Participants with measurements at given time point.
Outcome measures
| Measure |
HIV-1 Infected Participants
n=204 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
|
|---|---|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Glucose
Absolute values
|
4.88 mmol/L
Standard Deviation 0.690
|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Glucose
Change from BL
|
-0.10 mmol/L
Standard Deviation 0.838
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants with measurements at given time point.
Outcome measures
| Measure |
HIV-1 Infected Participants
n=202 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
|
|---|---|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Glucose
Absolute values
|
4.83 mmol/L
Standard Deviation 0.755
|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Glucose
Change from BL
|
-0.16 mmol/L
Standard Deviation 0.818
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Participants with measurements at given time point.
Outcome measures
| Measure |
HIV-1 Infected Participants
n=110 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
|
|---|---|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: HDL
Absolute values
|
1.53 mmol/L
Standard Deviation 0.594
|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: HDL
Change from BL
|
0.07 mmol/L
Standard Deviation 0.622
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants with measurements at given time point.
Outcome measures
| Measure |
HIV-1 Infected Participants
n=97 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
|
|---|---|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: HDL
Absolute values
|
1.43 mmol/L
Standard Deviation 0.465
|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: HDL
Change from BL
|
-0.00 mmol/L
Standard Deviation 0.568
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Participants with measurements at given time point.
Outcome measures
| Measure |
HIV-1 Infected Participants
n=35 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
|
|---|---|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Insulin
Absolute values
|
10.00 µEq/mL
Standard Deviation 2.342
|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Insulin
Change from BL
|
0.68 µEq/mL
Standard Deviation 2.683
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants with measurements at given time point.
Outcome measures
| Measure |
HIV-1 Infected Participants
n=33 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
|
|---|---|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Insulin
Absolute values
|
10.00 µEq/mL
Standard Deviation 2.358
|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Insulin
Change from BL
|
0.69 µEq/mL
Standard Deviation 2.760
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Participants with measurements at given time point.
Outcome measures
| Measure |
HIV-1 Infected Participants
n=111 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
|
|---|---|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: LDL
Absolute values
|
2.66 mmol/L
Standard Deviation 0.902
|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: LDL
Change from BL
|
-0.07 mmol/L
Standard Deviation 0.726
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants with measurements at given time point.
Outcome measures
| Measure |
HIV-1 Infected Participants
n=94 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
|
|---|---|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: LDL
Absolute values
|
2.92 mmol/L
Standard Deviation 0.874
|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: LDL
Change from BL
|
0.14 mmol/L
Standard Deviation 0.893
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Participants with measurements at given time point.
Outcome measures
| Measure |
HIV-1 Infected Participants
n=196 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
|
|---|---|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Serum Creatinine
Absolute values
|
81.50 µmol/L
Standard Deviation 19.488
|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Serum Creatinine
Change from BL
|
2.36 µmol/L
Standard Deviation 15.286
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants with measurements at given time point.
Outcome measures
| Measure |
HIV-1 Infected Participants
n=184 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
|
|---|---|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Serum Creatinine
Absolute values
|
82.13 µmol/L
Standard Deviation 19.096
|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Serum Creatinine
Change from BL
|
2.75 µmol/L
Standard Deviation 15.801
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Participants with measurements at given time point.
Outcome measures
| Measure |
HIV-1 Infected Participants
n=199 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
|
|---|---|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Total Cholesterol
Absolute values
|
5.11 mmol/L
Standard Deviation 0.951
|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Total Cholesterol
Change from BL
|
0.07 mmol/L
Standard Deviation 0.928
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants with measurements at given time point.
Outcome measures
| Measure |
HIV-1 Infected Participants
n=187 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
|
|---|---|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Total Cholesterol
Absolute values
|
5.12 mmol/L
Standard Deviation 1.118
|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Total Cholesterol
Change from BL
|
0.11 mmol/L
Standard Deviation 0.986
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Participants with measurements at given time point.
Outcome measures
| Measure |
HIV-1 Infected Participants
n=171 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
|
|---|---|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Triglycerides
Absolute values
|
1.72 mmol/L
Standard Deviation 1.025
|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Triglycerides
Change from BL
|
-0.70 mmol/L
Standard Deviation 9.106
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: Participants with measurements at given time point.
Outcome measures
| Measure |
HIV-1 Infected Participants
n=159 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
|
|---|---|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Triglycerides
Absolute values
|
1.61 mmol/L
Standard Deviation 0.832
|
|
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Triglycerides
Change from BL
|
-0.06 mmol/L
Standard Deviation 1.313
|
SECONDARY outcome
Timeframe: up to Week 48Adverse events were not recorded in a solicited manner as in an interventional trial, but were recorded by spontaneous reporting in line with the requirements described in European Medicines Agency (EMA) Guideline on Good Pharmacovigilance Practices (GVP) module VI and local pharmacovigilance practice of the Russian Federation.
Outcome measures
| Measure |
HIV-1 Infected Participants
n=216 Participants
HIV-1infected patients on any triple HAART with plasma HIV-1 RNA level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r+3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.
|
|---|---|
|
Number of Participants With Adverse Events
|
3 Participants
|
Adverse Events
HIV-1 Infected Participants
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HIV-1 Infected Participants
n=216 participants at risk
Treatment-experienced HIV-1 infected participants with an undetectable plasma HIV-1 RNA level
lopinavir/ritonavir: tablet
Lamivudine: tablet
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.46%
1/216 • Up to Week 48
This study is non-interventional. Therefore, adverse events were not recorded in a solicited manner as in an interventional trial, but were recorded by spontaneous reporting in line with the requirements described in EMA Guideline on GVP module VI and local pharmacovigilance practice of the Russian Federation.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.93%
2/216 • Up to Week 48
This study is non-interventional. Therefore, adverse events were not recorded in a solicited manner as in an interventional trial, but were recorded by spontaneous reporting in line with the requirements described in EMA Guideline on GVP module VI and local pharmacovigilance practice of the Russian Federation.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.46%
1/216 • Up to Week 48
This study is non-interventional. Therefore, adverse events were not recorded in a solicited manner as in an interventional trial, but were recorded by spontaneous reporting in line with the requirements described in EMA Guideline on GVP module VI and local pharmacovigilance practice of the Russian Federation.
|
|
Gastrointestinal disorders
Vomiting
|
0.93%
2/216 • Up to Week 48
This study is non-interventional. Therefore, adverse events were not recorded in a solicited manner as in an interventional trial, but were recorded by spontaneous reporting in line with the requirements described in EMA Guideline on GVP module VI and local pharmacovigilance practice of the Russian Federation.
|
|
General disorders
Drug ineffective
|
0.93%
2/216 • Up to Week 48
This study is non-interventional. Therefore, adverse events were not recorded in a solicited manner as in an interventional trial, but were recorded by spontaneous reporting in line with the requirements described in EMA Guideline on GVP module VI and local pharmacovigilance practice of the Russian Federation.
|
|
Investigations
Transaminases increased
|
0.46%
1/216 • Up to Week 48
This study is non-interventional. Therefore, adverse events were not recorded in a solicited manner as in an interventional trial, but were recorded by spontaneous reporting in line with the requirements described in EMA Guideline on GVP module VI and local pharmacovigilance practice of the Russian Federation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie 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. AbbVie 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 AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER