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

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®

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02547844

Enrollment

Registered

2015-09-11

Start date

2015-09-30

Completion date

2016-10-31

Last updated

2017-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1

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®.

Interventions

DRUGefavirenz + emtricitabina + tenofovir

DRUGrilpivirina + emtricitabina + tenofovir

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026