This trial is active, not recruiting.

Condition hiv-1
Treatments efavirenz + emtricitabina + tenofovir, rilpivirina + emtricitabina + tenofovir
Phase phase 4
Sponsor Hospital Universitari Vall d'Hebron Research Institute
Collaborator Gilead Sciences
Start date September 2015
End date October 2016
Trial size 30 participants
Trial identifier NCT02547844, EfaRiLipidomics


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®.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Patients assigned to the control group will continue receiving the same medication than before to be included in the study: Atripla (efavirenz + emtricitabina + tenofovir)
efavirenz + emtricitabina + tenofovir atripla
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)
rilpivirina + emtricitabina + tenofovir eviplera

Primary Outcomes

Changes in plasma lipid profile measured by lipidomic in patients with chronic HIV-1 with antiretroviral therapy and viral suppression.
time frame: 12 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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®
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Hospital Universitari Vall d'Hebron Research Institute.