Evolution of Plasma Lipid Profile in Patients With HIV1 Who Change Atripla to Eviplera Compared to Continue With Atripla
This trial is active, not recruiting.
|Treatments||efavirenz + emtricitabina + tenofovir, rilpivirina + emtricitabina + tenofovir|
|Sponsor||Hospital Universitari Vall d'Hebron Research Institute|
|Start date||September 2015|
|End date||October 2016|
|Trial size||30 participants|
|Trial identifier||NCT02547844, EfaRiLipidomics|
To compare the lipidomic profile in patients with HIV-1 with viral suppression changing efavirenz + emtricitabine + tenofovir (Atripla) to rilpivirine + emtricitabine + tenofovir (Eviplera®) versus a group of patients that continue with Atripla®.
|Intervention model||parallel assignment|
Changes in plasma lipid profile measured by lipidomic in patients with chronic HIV-1 with antiretroviral therapy and viral suppression.
time frame: 12 weeks
Male or female participants at least 18 years old.
Inclusion Criteria: - Patients aged 18 years or above - Patients infected with HIV-1 - Patients treated with Atripla at least the last 6 months. - Patients with virologic suppression (HIV RNA <50 copies / ml) for at least the last 6 months. - Women of childbearing potential must use contraception double barrier. - Voluntary signature of informed consent Exclusion Criteria: - Any acute or chronic (besides chronic HIV-1) disease that could interfere with the analysis of lipidomic - Women pregnant or lactating - Abuse of alcohol or other drugs - Body Mass Index (BMI)> 25 - Use of drugs that may affect lipid metabolism (lipid-lowering drugs, steroids ...) - Patients unable to understand the study protocol or any other condition that in the investigator's opinion could jeopardize compliance with the protocol - History or presence of allergy to any of the study drugs or their components
|Official title||Open Randomized Study to Assess the Evolution of Plasma Lipid Profile by Lipidomic in Patients Infected With Human Immunodeficiency Virus (HIV-1) With Viral Suppression That Change Atripla® to Eviplera® Compared to Continue With Atripla®|
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