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

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®.

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Key information

Conditions

HIV-1

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

efavirenz + emtricitabina + tenofovir

Drug

Other names: atripla

rilpivirina + emtricitabina + tenofovir

Drug

Other names: eviplera

Primary outcomes

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

Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Collaborators

Gilead Sciences

Registry information

Official study 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®

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Sep 11, 2015
Registry last updated: Jun 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed