HIV-1 Infection
Conditions
Keywords
antiretroviral therapy
Brief summary
This study seeks to assess the virologic effectiveness of dual therapy (lopinavir/ ritonavir (LPV/r) + lamivudine (3TC)) in treatment-experienced human immunodeficiency virus 1 (HIV-1) infected participants with an undetectable plasma HIV-1 (ribonucleic acid) RNA level (for at least 6 months) at the 48 week time point of treatment in the routine clinical settings of the Russian Federation.
Interventions
DRUGlopinavir/ritonavir
tablet
DRUGlamivudine
tablet
Sponsors
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 years and older (male and female). 2. HIV-1 infected 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 ago. 3. Cumulative HAART experience at least 6 months. 4. Authorization (Consent) for Use/Disclosure of Data signed by the patient.
Exclusion criteria
1. Contraindications to lopinavir/ritonavir and lamivudine 2. Previous participation in this program
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 48 | Week 48 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 24 | Baseline, Week 24 | — |
| Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 48 | Baseline, Week 48 | — |
| Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 24 | Week 24 | — |
| Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Untransformed Data) | Baseline, Week 24 | — |
| Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Base-10 Logarithm Transformed Data) | Baseline, Week 24 | — |
| Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Untransformed Data) | Baseline, Week 48 | 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). |
| Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Base-10 Logarithm Transformed Data) | Baseline, Week 48 | — |
| Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 48 | Baseline, Week 48 | — |
| Number of Participants Who Developed Resistance to Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs), and Protease Inhibitors (PIs) | Week 48 | — |
| Absolute Values and Change From Baseline in Anthropometric Measurements At Week 24 | Baseline, Week 24 | — |
| Absolute Values and Change From Baseline in Anthropometric Measurements At Week 48 | Baseline, Week 48 | — |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (U/L) | Baseline, Week 24 | — |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (U/L) | Baseline, Week 48 | — |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (µmol/L) | Baseline, Week 24 | — |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (µmol/L) | Baseline, Week 48 | — |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (U/L) | Baseline, Week 24 | — |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (U/L) | Baseline, Week 48 | — |
| Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 24 | Baseline, Week 24 | — |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (µmol/L) | Baseline, Week 48 | — |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Glucose | Baseline, Week 24 | — |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Glucose | Baseline, Week 48 | — |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: HDL | Baseline, Week 24 | — |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: HDL | Baseline, Week 48 | — |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Insulin | Baseline, Week 24 | — |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Insulin | Baseline, Week 48 | — |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: LDL | Baseline, Week 24 | — |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: LDL | Baseline, Week 48 | — |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Serum Creatinine | Baseline, Week 24 | — |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Serum Creatinine | Baseline, Week 48 | — |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Total Cholesterol | Baseline, Week 24 | — |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Total Cholesterol | Baseline, Week 48 | — |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Triglycerides | Baseline, Week 24 | — |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Triglycerides | Baseline, Week 48 | — |
| Number of Participants With Adverse Events | up to Week 48 | 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 European Medicines Agency (EMA) Guideline on Good Pharmacovigilance Practices (GVP) module VI and local pharmacovigilance practice of the Russian Federation. |
| Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (µmol/L) | Baseline, Week 24 | — |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HIV-1 Infected 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. | 216 |
| Total | 216 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Pregnancy | 3 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | HIV-1 Infected Participants |
|---|---|
| Absolute HIV-1 RNA Viral Load (Untransformed Data) | 25.00 copies/mL STANDARD_DEVIATION 0 |
| Age, Continuous | 38.1 years STANDARD_DEVIATION 8.5 |
| Alanine Aminotransferase (µmol/L) | 20.75 µmol/L STANDARD_DEVIATION 7.979 |
| Alanine Aminotransferase (U/L) | 31.48 U/L STANDARD_DEVIATION 33.91 |
| Arm Circumference | 30.03 cm STANDARD_DEVIATION 5.29 |
| Aspartate Aminotransferase (µmol/L) | 21.56 µmol/L STANDARD_DEVIATION 11.933 |
| Aspartate Aminotransferase (U/L) | 27.69 U/L STANDARD_DEVIATION 22.913 |
| CD4+T-Cell Counts (%) | 31.44 percentage of lymphocytes that are CD4+ STANDARD_DEVIATION 8.396 |
| CD4+T-Cell Counts (cells/mm^3) | 641.37 cells/mm^3 STANDARD_DEVIATION 251.417 |
| Glucose | 4.96 mmol/L STANDARD_DEVIATION 0.59 |
| High Density Lipoprotein (HDL) | 1.45 mmol/L STANDARD_DEVIATION 0.479 |
| Hip Circumference | 53.92 cm STANDARD_DEVIATION 7.096 |
| HIV-1 RNA Viral Load (Log10-Transformed Data) | 3.22 log10 copies/mL STANDARD_DEVIATION 0 |
| Insulin | 9.32 µEq/mL STANDARD_DEVIATION 2.085 |
| Low Density Lipoprotein (LDL) | 2.75 mmol/L STANDARD_DEVIATION 0.866 |
| Race/Ethnicity, Customized Caucasian | 216 Participants |
| Serum Creatinine | 78.61 µmol/L STANDARD_DEVIATION 18.136 |
| Sex: Female, Male Female | 144 Participants |
| Sex: Female, Male Male | 72 Participants |
| Total Cholesterol | 5.04 mmol/L STANDARD_DEVIATION 0.98 |
| Triglycerides | 2.29 mmol/L STANDARD_DEVIATION 8.107 |
| Waist Circumference | 82.79 cm STANDARD_DEVIATION 11.579 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 216 |
| other Total, other adverse events | 3 / 216 |
| serious Total, serious adverse events | 0 / 216 |
Outcome results
Primary
Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 48
Time frame: Week 48
Population: Participants with an assessment at given time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HIV-1 Infected Participants | Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 48 | 100 percentage of participants |
Secondary
Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Base-10 Logarithm Transformed Data)
Time frame: Baseline, Week 24
Population: Participants with data on HIV-1 RNA viral load at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-1 Infected Participants | 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 |
| HIV-1 Infected Participants | 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 |
Secondary
Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Untransformed Data)
Time frame: Baseline, Week 24
Population: Participants with data on HIV-1 RNA viral load at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-1 Infected Participants | 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 |
| HIV-1 Infected Participants | 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
Absolute Values and Change From Baseline in Anthropometric Measurements At Week 24
Time frame: Baseline, Week 24
Population: Participants with measurements at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-1 Infected Participants | Absolute Values and Change From Baseline in Anthropometric Measurements At Week 24 | Change from BL: waist circumference | 0.31 cm | Standard Deviation 5.998 |
| HIV-1 Infected Participants | Absolute Values and Change From Baseline in Anthropometric Measurements At Week 24 | Absolute values: arm circumference | 29.82 cm | Standard Deviation 4.617 |
| HIV-1 Infected Participants | Absolute Values and Change From Baseline in Anthropometric Measurements At Week 24 | Change from BL: arm circumference | -0.38 cm | Standard Deviation 2.953 |
| HIV-1 Infected Participants | Absolute Values and Change From Baseline in Anthropometric Measurements At Week 24 | Absolute values: hip circumference | 54.62 cm | Standard Deviation 8.112 |
| HIV-1 Infected Participants | Absolute Values and Change From Baseline in Anthropometric Measurements At Week 24 | Change from BL: hip circumference | 0.57 cm | Standard Deviation 5.575 |
| HIV-1 Infected Participants | Absolute Values and Change From Baseline in Anthropometric Measurements At Week 24 | Absolute values: waist circumference | 83.29 cm | Standard Deviation 12.282 |
Secondary
Absolute Values and Change From Baseline in Anthropometric Measurements At Week 48
Time frame: Baseline, Week 48
Population: Participants with measurements at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-1 Infected Participants | Absolute Values and Change From Baseline in Anthropometric Measurements At Week 48 | Absolute values: arm circumference | 30.05 cm | Standard Deviation 4.781 |
| HIV-1 Infected Participants | Absolute Values and Change From Baseline in Anthropometric Measurements At Week 48 | Change from BL: arm circumference | -0.20 cm | Standard Deviation 2.935 |
| HIV-1 Infected Participants | Absolute Values and Change From Baseline in Anthropometric Measurements At Week 48 | Absolute values: hip circumference | 55.25 cm | Standard Deviation 8.395 |
| HIV-1 Infected Participants | Absolute Values and Change From Baseline in Anthropometric Measurements At Week 48 | Change from BL: hip circumference | 1.14 cm | Standard Deviation 6.739 |
| HIV-1 Infected Participants | Absolute Values and Change From Baseline in Anthropometric Measurements At Week 48 | Absolute values: waist circumference | 83.64 cm | Standard Deviation 12.742 |
| HIV-1 Infected Participants | 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
Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 24
Time frame: Baseline, Week 24
Population: Participants with valid measurements at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-1 Infected Participants | 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 |
| HIV-1 Infected Participants | 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
Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 48
Time frame: Baseline, Week 48
Population: Participants with valid measurements at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-1 Infected Participants | 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 7.86 |
| HIV-1 Infected Participants | 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
Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 24
Time frame: Baseline, Week 24
Population: Participants with valid measurements at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-1 Infected Participants | 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 223.79 |
| HIV-1 Infected Participants | 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 165.06 |
Secondary
Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 48
Time frame: Baseline, Week 48
Population: Participants with valid measurements at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-1 Infected Participants | 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 |
| HIV-1 Infected Participants | 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
Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Base-10 Logarithm Transformed Data)
Time frame: Baseline, Week 48
Population: Participants with data on HIV-1 RNA viral load at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-1 Infected Participants | 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 |
| HIV-1 Infected Participants | 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 |
Secondary
Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Untransformed Data)
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).
Time frame: Baseline, Week 48
Population: Participants with data on HIV-1 RNA viral load at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-1 Infected Participants | 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 |
| HIV-1 Infected Participants | 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 |
Secondary
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (µmol/L)
Time frame: Baseline, Week 24
Population: Participants with measurements at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-1 Infected Participants | 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 |
| HIV-1 Infected Participants | 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
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (U/L)
Time frame: Baseline, Week 24
Population: Participants with measurements at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-1 Infected Participants | 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 |
| HIV-1 Infected Participants | 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
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (µmol/L)
Time frame: Baseline, Week 24
Population: Participants with measurements at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-1 Infected Participants | 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 |
| HIV-1 Infected Participants | 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 65.3 |
Secondary
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (U/L)
Time frame: Baseline, Week 24
Population: Participants with measurements at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-1 Infected Participants | 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 |
| HIV-1 Infected Participants | 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
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Glucose
Time frame: Baseline, Week 24
Population: Participants with measurements at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-1 Infected Participants | Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Glucose | Absolute values | 4.88 mmol/L | Standard Deviation 0.69 |
| HIV-1 Infected Participants | 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
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: HDL
Time frame: Baseline, Week 24
Population: Participants with measurements at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-1 Infected Participants | Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: HDL | Absolute values | 1.53 mmol/L | Standard Deviation 0.594 |
| HIV-1 Infected Participants | 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
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Insulin
Time frame: Baseline, Week 24
Population: Participants with measurements at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-1 Infected Participants | Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Insulin | Absolute values | 10.00 µEq/mL | Standard Deviation 2.342 |
| HIV-1 Infected Participants | 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
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: LDL
Time frame: Baseline, Week 24
Population: Participants with measurements at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-1 Infected Participants | Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: LDL | Absolute values | 2.66 mmol/L | Standard Deviation 0.902 |
| HIV-1 Infected Participants | 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
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Serum Creatinine
Time frame: Baseline, Week 24
Population: Participants with measurements at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-1 Infected Participants | Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Serum Creatinine | Absolute values | 81.50 µmol/L | Standard Deviation 19.488 |
| HIV-1 Infected Participants | 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
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Total Cholesterol
Time frame: Baseline, Week 24
Population: Participants with measurements at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-1 Infected Participants | Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Total Cholesterol | Absolute values | 5.11 mmol/L | Standard Deviation 0.951 |
| HIV-1 Infected Participants | 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
Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Triglycerides
Time frame: Baseline, Week 24
Population: Participants with measurements at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-1 Infected Participants | Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Triglycerides | Absolute values | 1.72 mmol/L | Standard Deviation 1.025 |
| HIV-1 Infected Participants | 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
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (µmol/L)
Time frame: Baseline, Week 48
Population: Participants with measurements at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-1 Infected Participants | Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (µmol/L) | Absolute values | 27.56 µmol/L | Standard Deviation 11.95 |
| HIV-1 Infected Participants | 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 10.95 |
Secondary
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (U/L)
Time frame: Baseline, Week 48
Population: Participants with measurements at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-1 Infected Participants | 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 |
| HIV-1 Infected Participants | 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
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (µmol/L)
Time frame: Baseline, Week 48
Population: Participants with measurements at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-1 Infected Participants | 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 |
| HIV-1 Infected Participants | 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
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (U/L)
Time frame: Baseline, Week 48
Population: Participants with measurements at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-1 Infected Participants | Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (U/L) | Absolute values | 26.92 U/L | Standard Deviation 21.05 |
| HIV-1 Infected Participants | 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 20.64 |
Secondary
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Glucose
Time frame: Baseline, Week 48
Population: Participants with measurements at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-1 Infected Participants | Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Glucose | Absolute values | 4.83 mmol/L | Standard Deviation 0.755 |
| HIV-1 Infected Participants | 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
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: HDL
Time frame: Baseline, Week 48
Population: Participants with measurements at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-1 Infected Participants | Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: HDL | Absolute values | 1.43 mmol/L | Standard Deviation 0.465 |
| HIV-1 Infected Participants | 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
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Insulin
Time frame: Baseline, Week 48
Population: Participants with measurements at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-1 Infected Participants | Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Insulin | Absolute values | 10.00 µEq/mL | Standard Deviation 2.358 |
| HIV-1 Infected Participants | Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Insulin | Change from BL | 0.69 µEq/mL | Standard Deviation 2.76 |
Secondary
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: LDL
Time frame: Baseline, Week 48
Population: Participants with measurements at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-1 Infected Participants | Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: LDL | Absolute values | 2.92 mmol/L | Standard Deviation 0.874 |
| HIV-1 Infected Participants | 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
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Serum Creatinine
Time frame: Baseline, Week 48
Population: Participants with measurements at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-1 Infected Participants | Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Serum Creatinine | Absolute values | 82.13 µmol/L | Standard Deviation 19.096 |
| HIV-1 Infected Participants | 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
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Total Cholesterol
Time frame: Baseline, Week 48
Population: Participants with measurements at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-1 Infected Participants | Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Total Cholesterol | Absolute values | 5.12 mmol/L | Standard Deviation 1.118 |
| HIV-1 Infected Participants | 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
Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Triglycerides
Time frame: Baseline, Week 48
Population: Participants with measurements at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-1 Infected Participants | Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Triglycerides | Absolute values | 1.61 mmol/L | Standard Deviation 0.832 |
| HIV-1 Infected Participants | 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
Number of Participants Who Developed Resistance to Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs), and Protease Inhibitors (PIs)
Time frame: Week 48
Population: Participants with HIV-1 RNA viral load detected levels of ≥ 50 copies/mL up to Week 24.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HIV-1 Infected Participants | 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 |
| HIV-1 Infected 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 |
| HIV-1 Infected 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
Number of Participants With Adverse Events
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 European Medicines Agency (EMA) Guideline on Good Pharmacovigilance Practices (GVP) module VI and local pharmacovigilance practice of the Russian Federation.
Time frame: up to Week 48
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HIV-1 Infected Participants | Number of Participants With Adverse Events | 3 Participants |
Secondary
Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 24
Time frame: Week 24
Population: Participants with an assessment at given time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HIV-1 Infected Participants | Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 24 | 99.5 percentage of participants |