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Completed

NCT Number: NCT02581202

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

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.

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Key information

Conditions

HIV-1 Infection

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years and older (male and female).
  • 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.
  • Cumulative HAART experience at least 6 months.
  • Authorization (Consent) for Use/Disclosure of Data signed by the patient.

Exclusion criteria

  • Contraindications to lopinavir/ritonavir and lamivudine
  • Previous participation in this program

Treatment and study plan

Lopinavir/ritonavir

Drug

tablet

Lamivudine

Drug

tablet

Primary outcomes

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

    Time frame: Week 48

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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)

Acronym: SIMPLE

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 20, 2015
Registry last updated
Jun 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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