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

HIV-1 Infection Clinical Trial

— SIMPLE  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02581202
• Other study ID #: P15-452
• Status: Completed
• Start date: December 21, 2015
• Est. completion date: May 27, 2017

Study information

• Verified date: May 2018
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: May 27, 2017
• Est. primary completion date: May 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV-1 Infection

Intervention

Drug:
• lopinavir/ritonavir
tablet
• lamivudine
tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 48		Week 48
Secondary	Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 24		Week 24
Secondary	Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Untransformed Data)		Baseline, Week 24
Secondary	Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Base-10 Logarithm Transformed Data)		Baseline, Week 24
Secondary	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
Secondary	Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Base-10 Logarithm Transformed Data)		Baseline, Week 48
Secondary	Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 24		Baseline, Week 24
Secondary	Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 48		Baseline, Week 48
Secondary	Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 24		Baseline, Week 24
Secondary	Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 48		Baseline, Week 48
Secondary	Number of Participants Who Developed Resistance to Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs), and Protease Inhibitors (PIs)		Week 48
Secondary	Absolute Values and Change From Baseline in Anthropometric Measurements At Week 24		Baseline, Week 24
Secondary	Absolute Values and Change From Baseline in Anthropometric Measurements At Week 48		Baseline, Week 48
Secondary	Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (U/L)		Baseline, Week 24
Secondary	Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (U/L)		Baseline, Week 48
Secondary	Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (µmol/L)		Baseline, Week 24
Secondary	Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (µmol/L)		Baseline, Week 48
Secondary	Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (U/L)		Baseline, Week 24
Secondary	Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (U/L)		Baseline, Week 48
Secondary	Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (µmol/L)		Baseline, Week 24
Secondary	Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (µmol/L)		Baseline, Week 48
Secondary	Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Glucose		Baseline, Week 24
Secondary	Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Glucose		Baseline, Week 48
Secondary	Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: HDL		Baseline, Week 24
Secondary	Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: HDL		Baseline, Week 48
Secondary	Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Insulin		Baseline, Week 24
Secondary	Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Insulin		Baseline, Week 48
Secondary	Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: LDL		Baseline, Week 24
Secondary	Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: LDL		Baseline, Week 48
Secondary	Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Serum Creatinine		Baseline, Week 24
Secondary	Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Serum Creatinine		Baseline, Week 48
Secondary	Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Total Cholesterol		Baseline, Week 24
Secondary	Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Total Cholesterol		Baseline, Week 48
Secondary	Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Triglycerides		Baseline, Week 24
Secondary	Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Triglycerides		Baseline, Week 48
Secondary	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