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

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)

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 Overview

• Status: Completed
• Conditions: HIV-1 Infection
• Intervention / Treatment: Drug: lopinavir/ritonavir; Drug: lamivudine

• Study Type: Observational
• Enrollment (Actual): 216

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

HIV-1 infected participants on any triple HAART with undetectable plasma HIV-1 RNA level for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r + 3TC in the routine clinical settings.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Drug: lopinavir/ritonavir; tablet; Drug: lamivudine; tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: Andrey Strugovschikov, MD, AbbVie

Study record dates

Study Major Dates

• Study Start: December 21, 2015
• Primary Completion (Actual): May 27, 2017
• Study Completion (Actual): May 27, 2017

Study Registration Dates

• First Submitted: October 19, 2015
• First Submitted That Met QC Criteria: October 19, 2015
• First Posted (Estimate): October 20, 2015

Study Record Updates

• Last Update Posted (Actual): June 6, 2019
• Last Update Submitted That Met QC Criteria: May 22, 2019
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: antiretroviral therapy
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Ritonavir; Lopinavir; Lamivudine
• Other Study ID Numbers: P15-452

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED