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®
1 other identifier
interventional
30
1 country
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®.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Sep 2015
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 10, 2015
CompletedFirst Posted
Study publicly available on registry
September 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedJune 14, 2017
June 1, 2017
1.1 years
September 10, 2015
June 13, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in plasma lipid profile measured by lipidomic in patients with chronic HIV-1 with antiretroviral therapy and viral suppression.
12 weeks
Study Arms (2)
efavirenz + emtricitabina + tenofovir
ACTIVE COMPARATORPatients assigned to the control group will continue receiving the same medication than before to be included in the study: Atripla (efavirenz + emtricitabina + tenofovir)
rilpivirina + emtricitabina + tenofovir
EXPERIMENTALPatients assigned to the experimental group will change the medication that are taking before to enter in the study ( atripla) for eviplera (rilpivirina + emtricitabina + tenofovir)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2015
First Posted
September 11, 2015
Study Start
September 1, 2015
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
June 14, 2017
Record last verified: 2017-06