Clinical trial NCT02581202: The Effectiveness of Dual Therapy (Lopinavir/Ritonavir + LamivudinE) in Treatment-Experienced HIV Infected Patients in the Russian Federation
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-1 Infection
Keywords: antiretroviral therapy
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-10-20
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 48
timeFrame: Week 48
Secondary outcomes:
measure: Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 24
timeFrame: Week 24
measure: Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Untransformed Data)
timeFrame: Baseline, Week 24
measure: Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Base-10 Logarithm Transformed Data)
timeFrame: Baseline, Week 24
measure: Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Untransformed Data)
timeFrame: Baseline, Week 48
measure: Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Base-10 Logarithm Transformed Data)
timeFrame: Baseline, Week 48
measure: Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 24
timeFrame: Baseline, Week 24
measure: Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 48
timeFrame: Baseline, Week 48
measure: Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 24
timeFrame: Baseline, Week 24
measure: Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 48
timeFrame: Baseline, Week 48
measure: Number of Participants Who Developed Resistance to Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs), and Protease Inhibitors (PIs)
timeFrame: Week 48
measure: Absolute Values and Change From Baseline in Anthropometric Measurements At Week 24
timeFrame: Baseline, Week 24
measure: Absolute Values and Change From Baseline in Anthropometric Measurements At Week 48
timeFrame: Baseline, Week 48
measure: Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (U/L)
timeFrame: Baseline, Week 24
measure: Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (U/L)
timeFrame: Baseline, Week 48
measure: Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (µmol/L)
timeFrame: Baseline, Week 24
measure: Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (µmol/L)
timeFrame: Baseline, Week 48
measure: Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (U/L)
timeFrame: Baseline, Week 24
measure: Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (U/L)
timeFrame: Baseline, Week 48
measure: Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (µmol/L)
timeFrame: Baseline, Week 24
measure: Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (µmol/L)
timeFrame: Baseline, Week 48
measure: Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Glucose
timeFrame: Baseline, Week 24
measure: Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Glucose
timeFrame: Baseline, Week 48
measure: Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: HDL
timeFrame: Baseline, Week 24
measure: Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: HDL
timeFrame: Baseline, Week 48
measure: Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Insulin
timeFrame: Baseline, Week 24
measure: Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Insulin
timeFrame: Baseline, Week 48
measure: Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: LDL
timeFrame: Baseline, Week 24
measure: Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: LDL
timeFrame: Baseline, Week 48
measure: Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Serum Creatinine
timeFrame: Baseline, Week 24
measure: Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Serum Creatinine
timeFrame: Baseline, Week 48
measure: Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Total Cholesterol
timeFrame: Baseline, Week 24
measure: Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Total Cholesterol
timeFrame: Baseline, Week 48
measure: Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Triglycerides
timeFrame: Baseline, Week 24
measure: Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Triglycerides
timeFrame: Baseline, Week 48
measure: Number of Participants With Adverse Events
timeFrame: up to Week 48
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Andrey Strugovschikov, MD
role: STUDY_DIRECTOR
References: