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

NCT ID: NCT02547844

Last Updated: 2017-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-10-31

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®.

Detailed Description

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Conditions

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HIV-1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

efavirenz + emtricitabina + tenofovir

Intervention Type DRUG

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)

Group Type EXPERIMENTAL

rilpivirina + emtricitabina + tenofovir

Intervention Type DRUG

Interventions

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efavirenz + emtricitabina + tenofovir

Intervention Type DRUG

rilpivirina + emtricitabina + tenofovir

Intervention Type DRUG

Other Intervention Names

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atripla eviplera

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role collaborator

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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EfaRiLipidomics

Identifier Type: -

Identifier Source: org_study_id

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