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

Completed

• Conditions: HIV-1 Infection
• Interventions: Drug: lopinavir/ritonavir; Drug: lamivudine

• Registration Number: NCT02581202
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-19
• Study First Submitted QC: 2015-10-19
• Study First Posted: 2015-10-20
• Study Start: 2015-12-21
• Primary Completion: 2017-05-27
• Study Completion: 2017-05-27
• Status Verified: 2018-05
• Results First Submitted: 2018-05-23
• Results First Submitted QC: 2018-12-20
• Results First Posted: 2019-03-29
• Last Update Submitted: 2019-05-22
• Last Update Posted: 2019-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

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.

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Exclusion Criteria

1. Contraindications to lopinavir/ritonavir and lamivudine
2. Previous participation in this program

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIV-1 infected participants	lopinavir/ritonavir	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.
HIV-1 infected participants	lamivudine	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 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 (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 (%) at Week 24	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 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
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
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 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.