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

June 13, 2017 updated by: Hospital Universitari Vall d'Hebron Research Institute

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®

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®.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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)
Drug: efavirenz + emtricitabina + tenofovir
Other Names:
  • atripla
Experimental: 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)
Drug: rilpivirina + emtricitabina + tenofovir
Other Names:
  • eviplera

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Collaborators

Gilead Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

September 10, 2015

First Submitted That Met QC Criteria

September 10, 2015

First Posted (Estimate)

September 11, 2015

Study Record Updates

Last Update Posted (Actual)

June 14, 2017

Last Update Submitted That Met QC Criteria

June 13, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EfaRiLipidomics

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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