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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Hospital Universitari Vall d'Hebron Research Institute

Collaborator
Gilead Sciences

Information provided by (Responsible Party)
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier
NCT02547844

First received: September 10, 2015
Last updated: June 13, 2017
Last Verified: June 2017
History of Changes
Purpose

Purpose

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®.

Condition Intervention Phase
HIV-1

Drug : efavirenz + emtricitabina + tenofovir
Drug : rilpivirina + emtricitabina + tenofovir
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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®

Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

Primary Outcome Measures

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

Enrollment: 30
Study Start Date: September 2015
Study Completion Date: October 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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 Name: 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 Name: eviplera
Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02547844

Locations

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

Sponsors and Collaborators

Hospital Universitari Vall d'Hebron Research Institute
Gilead Sciences
More Information

More Information


Responsible Party: Hospital Universitari Vall d'Hebron Research Institute  
ClinicalTrials.gov Identifier: NCT02547844   History of Changes  
Other Study ID Numbers: EfaRiLipidomics  
Study First Received: September 10, 2015  
Last Updated: June 13, 2017  

Additional relevant MeSH terms:
Tenofovir
Efavirenz
Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Emtricitabine

ClinicalTrials.gov processed this data on October 18, 2017
This information is provided by ClinicalTrials.gov.