The Effectiveness of Dual Therapy (Lopinavir/Ritonavir + LamivudinE) in Treatment-Experienced HIV Infected Patients in the Russian Federation

Study Overview
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Brief Summary
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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.

Official Title
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ProSpective, MultI-Center, Observational PrograM to Assess the Effectiveness of Dual TheraPy (Lopinavir/Ritonavir + LamivudinE) in Treatment-Experienced HIV Infected Patients in the Routine Clinical Settings of the Russian Federation (SIMPLE)

Conditions
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HIV-1 Infection

Intervention / Treatment
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* Drug: lopinavir/ritonavir
* Drug: lamivudine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV-1 infected participants<br>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. | Drug: lopinavir/ritonavir<br>* tablet<br>Drug: lamivudine<br>* tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 48 |  | Week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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). | Baseline, Week 48 | 
| 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 (%) at Week 24 |  | Baseline, Week 24 | 
| Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 48 |  | 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 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 Metabolic Parameters at Week 24: Aspartate Aminotransferase (µmol/L) |  | 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 | 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. | up to Week 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antiretroviral therapy