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

Phase 4

Completed

• Conditions: HIV-1
• Interventions: Drug: efavirenz + emtricitabina + tenofovir; Drug: rilpivirina + emtricitabina + tenofovir

• Registration Number: NCT02547844
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

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®.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-10
• Study First Submitted QC: 2015-09-10
• Study First Posted: 2015-09-11
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-13
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
efavirenz + emtricitabina + tenofovir	efavirenz + emtricitabina + tenofovir	Patients assigned to the control group will continue receiving the same medication than before to be included in the study: Atripla (efavirenz + emtricitabina + tenofovir)
rilpivirina + emtricitabina + tenofovir	rilpivirina + emtricitabina + tenofovir	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)

Primary Outcome Measures

Name	Time	Method
Changes in plasma lipid profile measured by lipidomic in patients with chronic HIV-1 with antiretroviral therapy and viral suppression.	12 weeks

Trial Locations

Locations (1)

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain