Evolution of Plasma Lipid Profile in Patients With HIV1 Who Change Atripla to Eviplera Compared to Continue With Atripla

Study Overview
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Brief Summary
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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®.

Official Title
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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®

Conditions
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HIV-1

Intervention / Treatment
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* Drug: efavirenz + emtricitabina + tenofovir
* Drug: rilpivirina + emtricitabina + tenofovir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: efavirenz + emtricitabina + tenofovir<br>Patients assigned to the control group will continue receiving the same medication than before to be included in the study: Atripla (efavirenz + emtricitabina + tenofovir) | Drug: efavirenz + emtricitabina + tenofovir<br> <br> * Other names: atripla;|
| Experimental: rilpivirina + emtricitabina + tenofovir<br>Patients assigned to the experimental group will change the medication that are taking before to enter in the study ( atripla) for eviplera (rilpivirina + emtricitabina + tenofovir) | Drug: rilpivirina + emtricitabina + tenofovir<br> <br> * Other names: eviplera;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in plasma lipid profile measured by lipidomic in patients with chronic HIV-1 with antiretroviral therapy and viral suppression. |  | 12 weeks |