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

AbbVie216 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

216

Conditions

HIV-1 Infection

Interventions

lopinavir/ritonavirDRUG

tablet

lamivudineDRUG

tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: Week 48

Secondary Outcomes

Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 24

Time frame: Week 24

Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Untransformed Data)

Time frame: Baseline, Week 24

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

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

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

Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 24

Time frame: Baseline, Week 24

Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 48

Time frame: Baseline, Week 48

Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 24

Data from ClinicalTrials.gov

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Time frame: Baseline, Week 24

Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 48

Time frame: 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)

Time frame: Week 48

Absolute Values and Change From Baseline in Anthropometric Measurements At Week 24

Time frame: Baseline, Week 24

Absolute Values and Change From Baseline in Anthropometric Measurements At Week 48

Time frame: Baseline, Week 48

Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (U/L)

Time frame: Baseline, Week 24

Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (U/L)

Time frame: Baseline, Week 48

Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (µmol/L)

Time frame: Baseline, Week 24

Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (µmol/L)

Time frame: Baseline, Week 48

Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (U/L)

Time frame: Baseline, Week 24

Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (U/L)

Time frame: Baseline, Week 48

Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (µmol/L)

Time frame: Baseline, Week 24

Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (µmol/L)

Time frame: Baseline, Week 48

Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Glucose

Time frame: Baseline, Week 24

Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Glucose

Time frame: Baseline, Week 48

Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: HDL

Time frame: Baseline, Week 24

Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: HDL

Time frame: Baseline, Week 48

Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Insulin

Time frame: Baseline, Week 24

Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Insulin

Time frame: Baseline, Week 48

Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: LDL

Time frame: Baseline, Week 24

Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: LDL

Time frame: Baseline, Week 48

Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Serum Creatinine

Time frame: Baseline, Week 24

Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Serum Creatinine

Time frame: Baseline, Week 48

Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Total Cholesterol

Time frame: Baseline, Week 24

Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Total Cholesterol

Time frame: Baseline, Week 48

Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Triglycerides

Time frame: Baseline, Week 24

Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Triglycerides

Time frame: 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.

Time frame: up to Week 48