Study With Dual Therapy Including Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) in Virologically Suppressed HIV-1 Infected Patients Experiencing Inconvenience, Toxicity, Negative Impact on Co-morbidities or Risk of Drug-drug Interactions With Their Current Regimen

Overview

Phase 3b, single arm, simplification study with dual therapy including Lamivudine (300 mg QD) plus Raltegravir (1200 mg QD) in virologically suppressed HIV-1 infected patients experiencing inconvenience, toxicity, negative impact on comorbidities or risk of drug-drug interactions with their current regimen.

Full Title of Study: “Phase 3b, Single Arm, Simplification Study With Dual Therapy Including Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) in Virologically Suppressed HIV-1 Infected Patients Experiencing Inconvenience, Toxicity, Negative Impact on Co-morbidities or Risk of Drug-drug Interactions With Their Current Regimen. RALAM-II Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 30, 2020

Interventions

  • Drug: Raltegravir
    • Raltegravir (1200 mg once a day)
  • Drug: Lamivudine
    • Lamivudine (300 mg once a day)

Arms, Groups and Cohorts

  • Experimental: Raltegravir + Lamivudine

Clinical Trial Outcome Measures

Primary Measures

  • Therapeutic failure
    • Time Frame: 48 weeks
    • therapeutic failure at week 48, includes virological failure, change in treatment for any reason, consent withdrawal, loss to follow-up or death

Secondary Measures

  • Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was inconenience
    • Time Frame: 48 weeks
    • Changes in quality of life calculated by EQ-5D-5L if reason of switch was inconvenience
  • Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was neurological toxicity
    • Time Frame: 48 weeks
    • Changes on Pittsburgh Sleep Quality Index for neurological toxicity
  • Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was cardiovascular toxicity or co-morbidity
    • Time Frame: 48 weeks
    • Changes on plasma lipids cholesterol LDL
  • Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was cardiovascular toxicity or co-morbidity
    • Time Frame: 48 weeks
    • Changes on plasma lipids cholesterol HDL
  • Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was cardiovascular toxicity or co-morbidity
    • Time Frame: 48 weeks
    • Changes on plasma lipids triglycerides
  • Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was skeletal toxicity
    • Time Frame: 48 weeks
    • Changes on dual energy x-ray absorptiometry bone density
  • Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was digestive toxicity
    • Time Frame: 48 weeks
    • Apperance of any adverse event that resolve their digestive toxicity: as diarrhea or digestive discomfort
  • Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was drug-drug interactions
    • Time Frame: 48 weeks
    • Proportion of drug-drug interaction with antirretroviral treatment
  • Therapeutic failure
    • Time Frame: 24 weeks
  • Virological failure
    • Time Frame: 24 weeks
    • Defined as two consecutive measurements of plasma viral load above 50 copies/ml
  • Virological failure
    • Time Frame: 48 weeks
    • Defined as two consecutive measurements of plasma viral load above 50 copies/ml
  • Proportion of patients with viral load below ultrasensitive HIV-1 RNA detection limit (limit of detection 1 copy/mL)
    • Time Frame: 48 weeks
  • Changes from baseline in cholesterol total
    • Time Frame: 24 weeks
  • Changes from baseline in HDL
    • Time Frame: 24 weeks
  • Changes from baseline in triglycerides
    • Time Frame: 24 weeks
  • Changes from baseline in insulin resistance (HOMA-IR)
    • Time Frame: 24 weeks
  • Changes from baseline in cholesterol LDL
    • Time Frame: 24 weeks
  • Changes from baseline in cholesterol LDL
    • Time Frame: 48 weeks
  • Changes from baseline in cholesterol total
    • Time Frame: 48 weeks
  • Changes from baseline in cholesterol HDL
    • Time Frame: 48 weeks
  • Changes from baseline in triglycerides
    • Time Frame: 48 weeks
  • Changes from baseline in and insulin resistance (HOMA-IR)
    • Time Frame: 48 weeks
  • Changes from baseline in body fat composition
    • Time Frame: 48 weeks
  • Changes from baseline in immune activation markers including CD38
    • Time Frame: 48 weeks
  • Changes from baseline in immune activation markers including HLA-DR
    • Time Frame: 48 weeks
  • Changes from baseline in biomarkers of inflammation IL-6,
    • Time Frame: 48 weeks
  • Changes from baseline in biomarkers of inflammation high sensitivity C-reactive protein
    • Time Frame: 48 weeks
  • Changes from baseline in biomarkers of mononuclear activation SD-14
    • Time Frame: 48 weeks
  • Changes from baseline in biomarkers of mononuclear activation SD-163
    • Time Frame: 48 weeks
  • Changes from baseline in sleep quality (Pittsburgh Sleep Quality Index)
    • Time Frame: 24 weeks
  • Changes from baseline in sleep quality (Pittsburgh Sleep Quality Index)
    • Time Frame: 48 weeks
  • Change from baseline in EQ-5D-5L
    • Time Frame: 24 weeks
  • Change from baseline in EQ-5D-5L
    • Time Frame: 48 weeks
  • Incidence of adverse events
    • Time Frame: 48 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Eligible patients will be males or females at least 18 years of age. Women of childbearing potential must have a negative pregnancy test within 10 days prior to randomization into the study. – Patients seropositive for HIV-1 using standard diagnostic criteria. – Patients experiencing inconvenience, toxicity, negative impact on comorbidities or risk of drug-drug interactions with their current regimen – Patients virologically suppressed during at least 12 months prior to inclusion (viral load <50 copies/mL). – Patients who have signed informed consent to participate in the study. Exclusion Criteria:

  • Pregnancy, lactation, or planned pregnancy during the study period. – Previous failure to an integrase inhibitor-containing regimen. – Previous failure to a Lamivudine or Emtricitabine-containing regimen. – Resistance mutations to Lamivudine or integrase inhibitor if any resistance test had been previously performed. – Any disease or history of disease which, in the opinion of the investigator, might confound the results of the study or pose additional risk to patient treatment. – Chronic hepatitis B.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • David Garcia Cinca
  • Collaborator
    • Fundacion Clinic per a la Recerca Biomédica
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: David Garcia Cinca, Clinical Research Manager – Hospital Clinic of Barcelona
  • Overall Contact(s)
    • Esteban Martinez, MD, +34.93.227.54.00, ESTEBANM@clinic.cat

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