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

HIV-1 Clinical Trial

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®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02547844
• Other study ID #: EfaRiLipidomics
• Status: Completed
• Phase: Phase 4
• First received: September 10, 2015
• Last updated: June 13, 2017
• Start date: September 2015
• Est. completion date: October 2016

Study information

• Verified date: June 2017
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV-1

Intervention

Drug:
• efavirenz + emtricitabina + tenofovir

• rilpivirina + emtricitabina + tenofovir

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall d'Hebron	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute	Gilead Sciences

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in plasma lipid profile measured by lipidomic in patients with chronic HIV-1 with antiretroviral therapy and viral suppression.		12 weeks