N/A
Completed N=216
The Effectiveness of Dual Therapy (Lopinavir/Ritonavir + LamivudinE) in Treatment-Experienced HIV Infected Patients in the Russian Federation
Source: ClinicalTrials.gov NCT02581202 ↗Enrolled (actual)
216
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 48 — 100 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 48 |
100 | — |
| SECONDARY Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 24 |
99.5 | — |
| SECONDARY Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Untransformed Data) |
25.22; 0.22 | — |
| SECONDARY Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Base-10 Logarithm Transformed Data) |
3.22; 0.01 | — |
| SECONDARY Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Untransformed Data) |
25.00; 0.00 | — |
| SECONDARY Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Base-10 Logarithm Transformed Data) |
3.22; 0.000 | — |
| SECONDARY Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 24 |
32.50; 0.96 | — |
| SECONDARY Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 48 |
33.11; 1.43 | — |
| SECONDARY Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 24 |
703.43; 64.70 | — |
| SECONDARY Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 48 |
752.44; 111.75 | — |
| SECONDARY Number of Participants Who Developed Resistance to Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs), and Protease Inhibitors (PIs) |
1; 1; 0 | — |
| SECONDARY Absolute Values and Change From Baseline in Anthropometric Measurements At Week 24 |
29.82; -0.38; 54.62; 0.57; 83.29; 0.31 | — |
| SECONDARY Absolute Values and Change From Baseline in Anthropometric Measurements At Week 48 |
30.05; -0.20; 55.25; 1.14; 83.64; 0.63 | — |
| SECONDARY Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (U/L) |
29.37; -1.31 | — |
| SECONDARY Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (U/L) |
28.35; -2.14 | — |
| SECONDARY Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (µmol/L) |
39.81; 19.06 | — |
| SECONDARY Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (µmol/L) |
27.56; 6.81 | — |
| SECONDARY Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (U/L) |
26.90; -0.38 | — |
| SECONDARY Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (U/L) |
26.92; -0.49 | — |
| SECONDARY Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (µmol/L) |
46.56; 25.00 | — |
| SECONDARY Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (µmol/L) |
27.19; 5.63 | — |
| SECONDARY Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Glucose |
4.88; -0.10 | — |
| SECONDARY Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Glucose |
4.83; -0.16 | — |
| SECONDARY Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: HDL |
1.53; 0.07 | — |
| SECONDARY Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: HDL |
1.43; -0.00 | — |
| SECONDARY Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Insulin |
10.00; 0.68 | — |
| SECONDARY Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Insulin |
10.00; 0.69 | — |
| SECONDARY Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: LDL |
2.66; -0.07 | — |
| SECONDARY Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: LDL |
2.92; 0.14 | — |
| SECONDARY Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Serum Creatinine |
81.50; 2.36 | — |
| SECONDARY Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Serum Creatinine |
82.13; 2.75 | — |
| SECONDARY Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Total Cholesterol |
5.11; 0.07 | — |
| SECONDARY Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Total Cholesterol |
5.12; 0.11 | — |
| SECONDARY Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Triglycerides |
1.72; -0.70 | — |
| SECONDARY Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Triglycerides |
1.61; -0.06 | — |
| SECONDARY Number of Participants With Adverse Events |
3 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 years and older (male and female).
- 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.
- Cumulative HAART experience at least 6 months.
- Authorization (Consent) for Use/Disclosure of Data signed by the patient.
Exclusion Criteria
- Contraindications to lopinavir/ritonavir and lamivudine
- Previous participation in this program
Data sourced from ClinicalTrials.gov (NCT02581202). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.