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

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ClinicalTrials.gov Identifier: NCT02581202
Recruitment Status : Completed
First Posted : October 20, 2015
Results First Posted : March 29, 2019
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
HIV-1 Infection Drug: lopinavir/ritonavir Drug: lamivudine

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Study Type : Observational
Actual Enrollment : 216 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Study Start Date : December 21, 2015
Actual Primary Completion Date : May 27, 2017
Actual Study Completion Date : May 27, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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




Primary Outcome Measures :
  1. Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 48 [ Time Frame: Week 48 ]

Secondary Outcome Measures :
  1. Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 24 [ Time Frame: Week 24 ]
  2. Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Untransformed Data) [ Time Frame: Baseline, Week 24 ]
  3. 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 ]
  4. Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Untransformed Data) [ Time Frame: 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).

  5. 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 ]
  6. Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 24 [ Time Frame: Baseline, Week 24 ]
  7. Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 48 [ Time Frame: Baseline, Week 48 ]
  8. Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 24 [ Time Frame: Baseline, Week 24 ]
  9. Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 48 [ Time Frame: Baseline, Week 48 ]
  10. 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 ]
  11. Absolute Values and Change From Baseline in Anthropometric Measurements At Week 24 [ Time Frame: Baseline, Week 24 ]
  12. Absolute Values and Change From Baseline in Anthropometric Measurements At Week 48 [ Time Frame: Baseline, Week 48 ]
  13. Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (U/L) [ Time Frame: Baseline, Week 24 ]
  14. Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (U/L) [ Time Frame: Baseline, Week 48 ]
  15. Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (µmol/L) [ Time Frame: Baseline, Week 24 ]
  16. Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (µmol/L) [ Time Frame: Baseline, Week 48 ]
  17. Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (U/L) [ Time Frame: Baseline, Week 24 ]
  18. Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (U/L) [ Time Frame: Baseline, Week 48 ]
  19. Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (µmol/L) [ Time Frame: Baseline, Week 24 ]
  20. Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (µmol/L) [ Time Frame: Baseline, Week 48 ]
  21. Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Glucose [ Time Frame: Baseline, Week 24 ]
  22. Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Glucose [ Time Frame: Baseline, Week 48 ]
  23. Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: HDL [ Time Frame: Baseline, Week 24 ]
  24. Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: HDL [ Time Frame: Baseline, Week 48 ]
  25. Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Insulin [ Time Frame: Baseline, Week 24 ]
  26. Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Insulin [ Time Frame: Baseline, Week 48 ]
  27. Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: LDL [ Time Frame: Baseline, Week 24 ]
  28. Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: LDL [ Time Frame: Baseline, Week 48 ]
  29. Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Serum Creatinine [ Time Frame: Baseline, Week 24 ]
  30. Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Serum Creatinine [ Time Frame: Baseline, Week 48 ]
  31. Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Total Cholesterol [ Time Frame: Baseline, Week 24 ]
  32. Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Total Cholesterol [ Time Frame: Baseline, Week 48 ]
  33. Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Triglycerides [ Time Frame: Baseline, Week 24 ]
  34. Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Triglycerides [ Time Frame: Baseline, Week 48 ]
  35. Number of Participants With Adverse Events [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02581202


Sponsors and Collaborators
AbbVie
Investigators
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Study Director: Andrey Strugovschikov, MD AbbVie
  Study Documents (Full-Text)

Documents provided by AbbVie:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02581202    
Other Study ID Numbers: P15-452
First Posted: October 20, 2015    Key Record Dates
Results First Posted: March 29, 2019
Last Update Posted: June 6, 2019
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by AbbVie:
antiretroviral therapy
Additional relevant MeSH terms:
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Ritonavir
Lopinavir
Lamivudine
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors