HIV-1 Infection MedDRA version: 18.0 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Eviplera®
Product Name: Eviplera®
Pharmaceutical Form: Tablet
INN or Proposed INN: EMTRICITABINE
CAS Number: 143491-57-0
Concentration unit: mg milligram(s)
Concentration type: equal
Conce
Sponsors
Fundació Hospital Vall Hebron Institut de Recerca
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients aged 18 years or above - Patients infected with HIV-1 - Patients in treatment with Atripla for at least the last six months. - Patients with virologic suppression ( RNA -HIV =65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: - Any acute or chronic disease (besides the chronic infection for HIV 1) that could interfere in the lipidomic analysis - Pregnant or nursing women - Abuse of alcohol or other drugs - BMI > 25 - Use of drugs that may affect lipid metabolism ( lipid lowering drugs , steroids ... ) - Patients unable to understand the protocol of the study or any other condition that in opinion of the investigator could compromise the fulfillment of the protocol - History or presence of allergy to any of the study drugs or their components
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the lipidómic profile of patients with HIV -1 viral suppression changing efavirenz + emtricitabine + tenofovir ( Atripla) to rilpivirine + emtricitabine + tenofovir ( Eviplera® ) versus a group of patients who continue to Atripla after 12 weeks from the switch;Secondary Objective: - To compare the lipidomics profile of maintaining Atripla® versus switching to Eviplera® at study week 24 - To compare for both groups the lipidomics profile at study week 24 with what is already known about liver steatosis lipidomics in uninfected patients - (Owliver, http://www.ncbi.nlm.nih.gov/pubmed/22364559 ) - To correlate lipidomic parameters with changes on lipid parameters used in clinical practice (total cholesterol, HDL, LDL, triglycerides, apolipoprotein AI and apolipoprotein B) and insulin resistance (HOMA-IR) - To assess inmuno-virology (CD4+ cell, CD8+ and viral load) after the switch at week 4, 12 and 24 of treatment. - To evaluate clinical safety at study week 4,12 and 24 in both treatment groups;Primary end point(s): Changes in plasma lipid profile measured by lipidomic in patients with chronic HIV -1 antiretroviral therapy and viral suppression;Timepoint(s) of evaluation of this end point: week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Depending on the endpoint the timepoint will be different: Weeks 4, 12 and 24;Secondary end point(s): - Related to HIV infection: CD4 + lymphocytes , CD8 + lymphocytes, HIV viral load - Related lipid profile : total cholesterol, HDL , LDL , triglycerides, apolipoproteins . - Related to glucose metabolism : glucose, insulin. - Related to the liver : liver function - Related to the safety: adverse events that could appear. - Relative to the adherence: drug accoutability | — |
Countries
Spain
Contacts
Public ContactServicio Enfermedades Infecciosas
Hospital Vall Hebron
Outcome results
None listed